Search Trials

Normally, white blood cells are produced in a controlled way by the bone marrow. In someone with AML or ALL, this production process is abnormal and immature cells are produced and sent into the blood stream. In this immature state, the cells affect the production of other normal cells and these cannot perform their usual functions. Therefore patients with AML or ALL are vulnerable to infection, anemia, and bleeding.

The purpose of this study is to understand what causes the white blood cells to grow abnormally, and to determine if there are novel agents that can be used to stop this abnormal growth. In this research project, a sample of blood and bone marrow will be studied in the laboratory to learn more about the nature of the disease, and to understand what causes the defect in the growth of these cells.

The purpose of this research study is to examine many aspects of gastrointestinal disease including pancreatic and colon cancer, including its genetics, its early stages, and the effects of cancer on other tissues such as muscle and adipose (fat) tissue. Tissues from patients (with cancer as well as from those without), who are undergoing pancreatic surgery, will be used in this research.

Share your health data and a little blood to help with studies on all kinds of diseases— cancer, diabetes, heart disease. A ready pool of samples and treatment histories speeds up research. It’s simple to help. And your info is so important to the search for new ways to prevent and treat illnesses.

Want to make an impact in just 20 minutes? Give some blood, answer some questions, and share your health records with your study team’s database. Researchers use it to find disease patterns and search for new ways to prevent and treat illnesses.

Recruiting Research Participants for a New Study on the “Genetics of Prostate Cancer”

At the time of conception, fertilization of the egg by the sperm brings together the genetic material (DNA) from both parents, half from the mother and half from the father, producing the embryo. In the very early stages of embryonic development, the embryo is made up of cells that have the potential to develop into all types of cells, like skin, muscle, liver, brain, pancreas, breast, ovary, fallopian tube, or prostate cells. Because of this ability, these cells are called “pluripotent” embryonic stem cells (ESCs). However, about a week after fertilization, the embryonic cells lose their ability to develop into all of the different cells and tissues of the body and gradually “differentiate” into the various tissues and organs that have different specific functions. So, there is a relatively narrow window during which pluripotent ESCs exist in the embryo.

At the end of the in vitro fertilization (IVF) process for couples undergoing subfertility treatment, the doctors are usually left with one-week-old embryos. In 1998, using such embryos for research, scientists figured out how to grow pluripotent ESCs in the lab that can stay in their pluripotent state if the right growth conditions are present. Changing the growth conditions in certain ways, scientists learned how to stimulate the ESCs to go through a process called “differentiation,” in which the stem cells can develop into any of the different cell types present in the body. ESCs were used in the early animal cloning experiments that produced the cloned ewe named “Dolly;” however, cloning human cells is illegal. While ESCs offer promising and exciting opportunities, like the possibility of growing organs in the lab, because their production involves technical and ethical problems, efforts were directed to produce pluripotent stem cells from mature cells to avoid the use of embryos.

In 2007, Japanese researchers found an amazing way (for which they received a Nobel Prize) to transform mature cells, like regular skin or blood cells, directly into stem cells without using human eggs. They found a combination of proteins that, if injected into mature cells, gradually reprogrammed them into induced pluripotent stem cells, abbreviated iPSCs.

Research Project

Drs. Dan Theodorescu and Clive Svendsen, the Principal Investigators at the Cedars-Sinai Medical Center in Los Angeles, California in collaboration with Dr. William Catalona, the Principal Investigator at Northwestern University are engaged in research using iPSCs to develop a model of human prostate cancer using iPSCs from men who carry BRCA2 mutations that are related to a higher risk for developing aggressive prostate cancer (the Cedars-Sinai team has already accomplished this for ovarian cancer in women who carry BRCA1 mutations). As study controls, they will also enroll men with non-BRCA2-related prostate cancer and those without prostate cancer. They will not use embryos.

In the laboratory, the researchers will take the white blood cells from a blood sample back in time to when they were capable of making any cell type in the body and differentiate them forward into prostate cells carrying (or for non-BRCA2-mutation carriers, not carrying) the BRCA2 mutation in a petri dish. Using these transformed prostate cells, they will use current genetic engineering and molecular biology research methods to study the mechanisms of the transformation of normal prostate cells into aggressive prostate cancer cells. This model also can be used in cell-signaling studies and drug screening studies for designing future therapies. The bank of prostate iPSCs that they will create may be shared with research institutions around the world.

These researchers are now recruiting men and their male family members who carry a BRCA2 mutation and other prostate cancer patients and controls without prostate cancer to participate in this study. This research is being performed to discover the causes of prostate cancer and how it is passed down in families using the BRCA2 mutation as a model system and also can be applied to non-BRCA2-related cancers.

This study is called “The genetics of prostate cancer” and is approved by the Institutional Review Boards at Northwestern University (STU00018651) and Cedars Sinai, whose function is to protect the rights of research subjects and to oversee ethical issues. Participation in this study will involve having up to 50 ml of your blood drawn (10 teaspoons), and completing family history questionnaires (baseline and follow-ups) and clinical follow-up questionnaires, if applicable. The time involved includes the time required to read the 10-page consent form, and the time required to travel to Northwestern Memorial Hospital, Galter Pavilion, 675 North St. Clair Street, Chicago, IL 60611 for the research blood draw.If it is not convenient for you to come to our clinic you may be able to get blood drawn at a clinic of your choice and we will arrange to have it shipped to Cedars-Sinai in Los Angeles, California. It will take about 20 to 40 minutes to complete the questionnaire. In the case that your family history suggests familial prostate cancer, Dr. Catalona may want your family members to participate in the study as well. You may be asked to contact your relative(s) about the study. We will follow up with a family history follow-up questionnaire annually, which takes 15 to 30 minutes to finish, to update the file. If you develop prostate cancer, we will want you to fill out a clinical follow-up questionnaire about prostate cancer and follow you up with the questionnaire annually as well, which takes 10 minutes to finish.

In addition, we may request up one or more additional blood samples of 10 to 20 ml (2-4 teaspoons) from you at a later date, depending on the evolving needs of the study. You may refuse to provide these follow-up blood samples without affecting your participation in this study. The blood sample(s) will be saved for future analysis. Efforts will be made to limit the use and disclosure of your personal information, including research studies and medical records, to people who have a need to review this information. We cannot promise complete secrecy. Organizations that may inspect and copy your information include the IRB and other representatives of this institution.

Research results will not be available to you or your physician except under extraordinary circumstances. These are situations in which a life-threatening medical disorder is discovered for which medical treatment is available to prevent or alleviate long-term medical complications. If such a situation should occur, we will contact you via phone, email or mail.

Those interested in participating may contact Dr. Catalona at 312 695-4471 or william.catalona@nm.org.

Further background information on stem cells is available from the author who created the background information for this article: Meshorer E (2020) What Are Embryonic Stem Cells and How Can They Help Us?. Front. Young Minds. 8:32. doi: 10.3389/frym.2020.00032. Copyright © 2020 Meshorer

The main purpose of this project is to collect samples for research. The samples will be stored at the Pathology Core Facility (PCF) of the Robert H. Lurie Comprehensive Cancer Center of Northwestern University Medical School (NUMS). PCF serves as the centralized resource that addresses the sample collection needs for the research community. The samples collected can be used by researchers at Northwestern University and third party commercial and non-profit institutions who have approval from their Institutional Review Board (a committee which is responsible for the ethical oversight of the study) for their projects.

You will be asked to donate a sample of blood. In addition, any extra tissue or fluid from what has been collected from you for your routine care will be used. Examples of samples include but are not limited to tissue, blood, urine, and bone marrow.

The purpose of this research study is to help advance the scientific understanding of breast cancer. A portion of breast or skin tissue and a sample of blood, along with clinical information, will be collected and stored in a database for research purposes only.

Only tissue or fluid in excess of that required for clinical diagnosis and/or staging will be collected. Specific clinical data will include: treatment for cancer (surgical procedures, chemo or hormone therapy, radiation), cancer outcome (recurrence, metastases, death due to disease, and death without disease, alive, alive with disease).

In this research project, samples of blood and bone marrow will be studied in the laboratory to learn more about the nature of chronic myelogenous leukemia (CML) cells and how various medications and chemical agents affect them.

The purpose of this study is to learn about how CML leukemia cells become resistant to medications or progress to acute leukemia (blast crisis). This may prove to be helpful in the design of new more effective drugs for the treatment of CML in the future.

In this research study, samples of bone marrow or peripheral blood will be collected from patients with chronic myeloid leukemia (CML) to learn more about the effect of some new drugs on CML cells in the laboratory. The purpose of this study is to understand how these new drugs stop leukemia cells from growing. This research may prove to be helpful in the design of new and more effective treatments for leukemia in the future.

The Northwestern Brain Tumor Institute (NBTI) currently uses an electronic database to collect and store information about patients who come to the NBTI for evaluations, including diagnosis, treatment, follow-up, and/or to obtain additional opinions. This database is called the Northwestern Brain Tumor Institute Database or NBTIDB, and it was developed to replace older paper methods for collecting and storing information.

The purpose of this study is to allow researchers involved with the NBTIDB to use data stored in it for future research studies and projects. The NBTIDB also allows researchers to track whether or not patients have agreed to allow their information to be linked to their leftover tissue samples, which are kept in the hospital’s pathology department, for future research studies.

Researchers have found that about 60% of patients with acute myeloid leukemia (AML) will obtain a remission following treatment with combinations of chemotherapy drugs. However, relapse after treatment remains a problem, and can be as high as 80% in some types of AML patients. Therefore, it would be beneficial to identify specific treatment approaches for patients at a high risk for relapse. One characteristic associated with high relapse rates is an increase in proteins that are referred to as Hox proteins in the leukemia cells. Increase in Hox proteins prevents production of some other proteins, including a protein referred to as Triad1. An increase in Triad1 protein in bone marrow cells may be important to control the growth of such cells. Decreased Triad1 in leukemia cells may therefore promote their growth, but this has not been previously studied.

The purpose of this study is to investigate if the lack of Triad1 in leukemia cells contributes to resistance of some leukemias to chemotherapy drugs. This research may prove to be helpful in the design of new and more effective treatments for leukemia in the future.

At a time when you are having a bone marrow biopsy and aspirate performed as part of your standard medical care, about an additional 2.5 teaspoons (12.5 mL) of bone marrow will be collected for this research study.

Researchers would like to create a bio-specimen bank of tissue, blood, urine and saliva, which would then be used to study cancer and find better ways to detect, prevent, diagnose, treat and provide better care for future patients. Some of these studies may be about how genes affect the development of cancer, response or resistance to treatment as well as prognosis (course of disease and overall outcome including survival). Other studies may aim to identify measurable substances in the blood and/or urine (known as biomarkers) that can indicate early development of cancer, worsening or relapse of disease and response to treatment. Some studies may lead to new products, such as drugs or tests for detection of cancer.

The purpose of this registry is to collect clinical information on all consenting head and neck cancer patients seen at the Northwestern Medical Group (NMG) or Northwestern Memorial Hospital (NMH). With this information, researchers will conduct studies to learn more about the subtypes of head and neck cancers and determine the most effective treatments. The registry will also allow us to identify possible subjects for future studies.

The purpose of the study is to gather information about your cancer and the treatment you receive as a part of your routine clinical care. In this study, we are developing a research registry, which is a bank of information about many patients.

We are interested in learning about the relationship between your cancer and the different types of tests available to identify the best treatment option for you. That is, we are interested in the tests that identify possible ‘mutations’ (e.g., changes) or ‘drivers’ within your tumor, what treatments you receive after getting these tests, and how your cancer responds to the treatments.

The tests known as next generation sequencing or “NGS” are usually done on your cancer tissue or blood samples as a part of your routine clinical care. Your doctor can use the information to identify the best treatment option for you after discussing it with other doctors. These routine tests will be performed whether you participate in this study or not, but we want to collect the information about this process for this study.

If you participate in this study, extra samples of your blood will be collected and stored, and your health information from your medical record and NGS lab results will be collected and stored.

The purpose of this study is to allow researchers studying and treating melanoma and other cancers to have access to tissue for research purposes only. Northwestern University may use your medical record information, as well as tumor, blood, saliva, urine, and fecal samples (collectively called “tissue”) for research studies to help us understand melanoma and other skin cancers. Biopsies and surgery of your cancer will not be a part of this study but will be performed as part of your standard care.

The purpose of this study is to determine if including thedrug olaparib taken along with radiation treatment decreases the recurrence of cancerin patients who have inflammatory breast cancer and have already hadchemotherapy and surgery to remove the cancer. The drug olaparib is already approved by the Food and DrugAdministration (FDA) for use in ovarian, fallopian tube, peritoneal cancer, andgBRCA mutated her2-negative metastatic breast cancer, however olaparib is notapproved for inflammatory breast cancer.

The purpose of this study is to compare any good and bad effects of using proton therapy to using photon

therapy. Photon therapy is the usual treatment approach for brain cancer. Proton therapy uses a beam of

proton particles to send radiation inside the body to the tumor. This study will allow the researchers to know

whether proton therapy is better, the same, or worse than the usual approach. Proton therapy may have less

negative effects on brain function than photons because less brain is exposed to radiation when proton therapy

is used. However, proton therapy might also be associated with more frequent tumor recurrences.

The purpose of this study is to test your tumor tissue for certain biomarker (which may be the cause of your cancers, such as specific mutations in certain proteins). This will help determine your eligibility to participate in either matched sub-studies involving investigational agents that targets the specific mutated protein or alternatively to un-matched sub-studies.

The purpose of this research study is to create a MTBC biorepository (the “MTBC Biobank”) of human biospecimens (the “Biospecimens”) and medical and health history information, for example, test and treatment results, age, gender, history of sun exposure (the “Annotating Data”). This part of the project is called the “Biobanking Study”. The second purpose is for MTBC to provide the Biospecimens and/or Annotating Data from the MTBC Biobank to researchers around the world for them to use in specific studies in order to study melanoma (“Future Use Study).

Melanoma is a lethal form of skin cancer and more research is necessary to help scientists to understand what causes it, how to diagnose it, how it can be prevented, and how it can be treated. To do this research, scientists need biospecimens (like biopsied tissue and blood samples) from people who have been diagnosed with melanoma and other skin disorders. This study will help scientists learn about melanoma and the projects being conducted on behalf of the Melanoma Tissue Bank Consortium(“MTBC”).

In the study, there will be many patients, like you, with hepatocellular carcinoma (HCC) who are eligible to receive a treatment called Y90 radioembolization and who may also be liver resection candidates.

Y90 radioembolization is a non-invasive, out-patient treatment that uses radioactive beads (microspheres), which are tiny glass particles that are loaded with radiation. The beads are injected into an artery of the liver that supplies blood to the tumor(s). The beads flow to the tumor(s) and become trapped inside. The beads release the Y90 radiation inside the tumor(s).

Liver resection is used to remove the part of the liver that has the liver tumor(s). It has been shown that Y90 radioembolization can increase the untreated liver’s size and volume. Patients with HCC may be liver resection candidates if they have a large enough liver.

The purpose of this research is to determine if there is an ideal Y90 dose to increase liver volume. This research may help determine the best Y90 dose for future patients who need a larger liver to have a liver resection.

If you participate in this study, you will have standard-of-care Y90 radioembolization as well as study-specific imaging and two optional liver biopsies. You will participate in the study for up to 3 months. Your health status will continue to be followed for up to 5 years.

Patients enrolled in the study will receive up to $195.00 for their participation.

The purpose of this research is to find a safe and tolerable dose of the study drug, IMSA101, for the treatment of your type of cancer and other types of cancer.

This study is being done to answer the following question: Can we prolong life for patients with

advanced kidney cancer, by adding a drug called cabozantinib to another treatment after

receiving the standard treatment?

We are doing this study because we want to find out if this approach isbetter or worse than the usual approach for your advanced kidney cancer. The usual approach is defined as care mostpeople get for advanced kidney cancer.

The purpose of this study is to compare the treatment of carboplatin/paclitaxel and letrozole hormonal therapy to letrozole alone. The use of the hormonal therapy drug letrozole without chemotherapy may shrink or stabilize cancer in the same way that chemotherapy also does, but without the added side effects of chemotherapy. Letrozole is a drug called an aromatase inhibitor, which indirectly stops the body from producing estrogen.

This study will investigate if this approach is better, the same, or worse than the usual approach. In order to determine if the use of letrozole alone helps to improve treatment for patients with low-grade serous ovarian or peritoneal cancer compared to combined chemotherapy and letrozole, half of patients in this study will receive letrozole with paclitaxel/carboplatin and the other half will receive letrozole alone. The study doctors will be looking to see if the letrozole alone prolongs the time cancer is in remission, or the duration of time participants are alive after treatment.

Letrozole is approved by the FDA for breast cancer, but is not FDA approved for ovarian cancer and is therefore considered experimental in this setting.

Participants will get either the combination of paclitaxel and carboplatin for four and a half months followed by letrozole or letrozole alone. Patients who are assigned to letrozole monotherapy will continue taking the letrozole for as long as they are tolerating the drug (i.e., have not developed any allergies or severe side effects with the medication) and have not experienced a recurrence or progression of their disease.

After participants finish their study treatment, their doctor and study team will continue to follow their condition and watch for side effects during clinic visits or by phone. Participants will be checked every 3 months for the first 3 years after treatment. After that, this will happen every 6 months for two years.

The purpose of this study is to test good and bad effects of different drugs against metastatic brain tumors with altered genes. This trial is trying to see if tumor genetic testing would be helpful at guiding treatment in patients such as you. Researchers have looked at the DNA material (genes) that can be affected in brain metastases and have found several genes that are altered, or mutated. There are medications that target these genes.

We are doing this study because we want to find out if this approach is better or worse than the usual approach for your metastatic cancer. The usual approach is defined as care most people get for your metastatic cancer.

This study will helpthe study doctors find out if this different approach is the same as the usualapproach. To decide if it is aseffective, the study doctors will be looking to see if the study approach showsat least the same results as the normal approach.

This study has 2 studygroups.

· Participants in groupA will get the standard dose of chemoradiation therapy: this includesMitomycin-C and 5-Fluorouracil or Capecitabine, as well as radiation. Therewill be 28 radiation treatment sessions in this group.

· Group 2 (Arm B)

Participants in group2 you will get the lower dose of chemoradiation therapy: this includesMitomycin-C and 5-Fluorouracil or Capecitabine, as well as radiation. Therewill be 20 or 23 radiation treatment sessions in this group, depending on thesize of the tumor.

Prostate cancer is the most commonly diagnosed malignancy in U.S. men. There are approximately 1 million prostate biopsy performed annually in the U.S. Almost all biopsies are performed as an office based procedure in under 15 minutes. The precision of biopsy has improved over the last decade with the introduction of MRI guidance/targeting of suspicious lesions within the prostate.

However, significant limitations remain with this approach, including a significantly increasing risk of post-biopsy infection. This arises because more than 97% of all prostate biopsy are performed via a transrectal approach that introduces rectal bacteria with each pass of the biopsy needle into the sterile urinary tract. The current risk of post-transrectal biopsy infection, even with antimicrobial prophylaxis, is high at approximately 7% overall with 3% (30,000 men) requiring hospitalization annually.

Transperineal biopsy is an alternate approach that eliminates the direct introduction of bacteria from the rectum to the prostate. This approach, which is perfomed without antimicrobial prophylaxis, instead passes the biopsy needle through the perineal skin and pelvic floor.

Transperineal biopsy has not been widely adopted for several reasons. Historically, it has been considered too painful for patients in the clinic and thus was traditionally performed under general anesthesia. The added time, inconvenience and cost has limited its national adoptance. Second, when transrectal biopsy was initially adopted over 40 years ago, antibiotic resistance of rectal flora was not a challenge.

Beyond the potential for in-office transperineal biopsy to significantly reduce or eliminate biopsy infections, transperineal biopsy may also improve cancer detection: studies of transperineal biopsy (performed under general anesthesia) demonstrate higher detection rates for prostate cancer, particularly for anterior zone tumors, compared to transrectal biopsy. This is notable, as anterior tumors are difficult to sample with transrectal. Anterior tumors are also twice as likely to occur in African American men. In fact, our research demonstrates that some of the outcomes disparities in African American men may stem from an underdiagnosis of anterior prostate cancers.

Although transrectal biopsy is used widely, it is associated with a significant and increasing risk of biopsy infections due to growing antibiotic resistance, highlighting the urgent need for a safer alternative approach to prostate biopsy. The study investigators have refined a transperineal approach under local anesthesia with MRI-targeting/guidance without the need for antibiotic prophylaxis. The investigators hypothesize that transperineal MRI targeted biopsy will: (1) largely eliminate post-biopsy infections and costly hospitalizations for urosepsis; (2) be performed in the office with similar discomfort and non-infectious complications compared to transrectal MRI targeted biopsy; and (3) have significantly better detection of prostate cancer.

This multi-center randomized controlled trial will be conducted to evaluate in-office transperineal MRI targeted vs. transrectal MRI targeted biopsy, the current gold standard. This has transformative impact to change current standard of practice.

The purpose of this research study is to determineif the experimental therapy called JCAR017 is effective and safe to treatFollicular Lymphoma or Marginal Zone Lymphoma.

This study will have 4 cohorts or patientgroups. Assignment to one of these patient groups depends on if you haveFollicular Lymphoma or Marginal Zone Lymphoma and the number and type oftreatments that you have received in the past, as well as how long it took foryour lymphoma to return after your last treatment. Everyone in all 4 patientgroups will receive the same dose of JCAR017 T cells. JCAR017 is a type oftherapy known as chimeric antigen receptor (CAR) T cell therapy which isco-developed with Juno Therapeutics. The visit schedule will also be the samefor all 4 patient groups. At the time you decide to take part in the study andgo through the screening procedures, it will be determined which patient groupyou will be assigned to.

In this study, your immunecells will be collected from your blood in a procedure called leukapheresis.The T cells will be separated from the collected immune cells and will bemodified in a laboratory. In the laboratory, a new gene will be put into your Tcells using genetic modification techniques. After they have been modified, thecells will be grown in the laboratory to reach the expected dose for thetreatment. Adding in the new gene may enable your T cells (now called JCAR017 Tcells) to bind to the CD19 protein, which your type of cancer cells carry ontheir surface. Binding to these cells activates the JCAR017 T cells, and theyattack the cancer cells. The JCAR017 T cells will persist in your body afterattacking the cancer cells, you will be monitored during the study to evaluatehow long these JCAR017 T cells persist. The JCAR017 T cells will be given backto you via infusion (IV).

Note:This is only a partial description of treatment. Please contact the Robert H.Lurie Comprehensive Cancer Center of Northwestern University if you areinterested in the trial.

Primary Aim:

To determine the 28-daymortality rate from the time of COVID 19 diagnosis for CLL patients infectedwith SARS-CoV2 at MSKCC and other institutions.

Secondary Aims:

To describe baseline characteristics, prior and current CLL directed therapies, COVID19 clinical course and outcomes for CLL patients infected with SARS-CoV2.

To examine relationships between CLL directed therapy and COVID19 disease course and outcomes.

To examine current practices regarding management of CLL directed therapy in CLL patients infected with SARS-CoV2.

All prospective patients will undergo screening tests to determine if they are eligible to take part in the study. A computer will by chance assign patients to one of the two arms in the study. This is called randomization.

•Arm A: Carboplatin + Pemetrexed + Avastin + Tecentriq

•Arm B: Carboplatin + Pemetrexed + Avastin

Arm A: Participants will receive carboplatin, pemetrexed, Avastin and Tecentriq for 4 cycles in the treatment phase, followed by pemetrexed, Avastin and Tecentriq for the rest of the cycles, called the maintenance phase.

Arm B: Participant will receive carboplatin, pemetrexed and Avastin for 4 cycles in treatment phase, followed by pemetrexed and Avastin during the following cycles of the maintenance phase.

Participants will be asked to take the study drugs as long as they are benefitting from the treatment or their disease does not get worse. Participants will be removed from the study if the study doctor thinks that they have unacceptable toxicities due to the study drug/s and it is in their best interest to stop participating in the study.

All the drugs will be administered intravenously on Day 1 of each cycle. Each cycle is made of 21 days. The number of cycles will depend on how participants respond to treatment. During the study, participants will have a CT scan every 6 weeks (every 9 weeks during the maintenance phase). Participants will also undergo a physical exam, blood tests, performance status, and vital signs. Blood will be collected during the study. A biopsy for tissue will be collected if the participant agrees.

Note: This is only a partial description of treatment. Please contact the Robert H. Lurie Comprehensive Cancer Center of Northwestern University if you are interested in the trial.

The purpose of this study is to determine if the study drug, ALVR-105, is safe and works well in the treatment for HC. The study will compare ALVR-105 to placebo in reducing your bladder pain, reducing the amount of blood in your urine, and seeing if specific viruses are lowered in your blood and urine.

This is a randomized double-blind study. “Randomized” means that you will be randomly assigned (like the flip of a coin) to receive either ALVR-105, or placebo (inactive substance). You will have a 60% chance of receiving ALVR-105 and a 40% chance of receiving placebo.

Your participation in this study will last approximately 6 months and include about 10 study visits to the study site. Some of these study visits will occur when you are already in the hospital in which case the study team will visit you to complete the study visit.

In healthy people, T-cells defend the body against viruses. Because of the early stage / premature engraftment and /or immune suppressing therapy given for the HCT, T-cell numbers are low, and it is more difficult for the body to control viruses that are already in your body, but are not active. If you have low T-cell numbers and your body cannot control viruses, some of these viruses can cause HC.

Viralym-M (ALVR-105) is a research study medicine that contains T-cells made from healthy human donors to potentially help defend your body against specific viruses. The research study medicine is “investigational.” It has not been approved by the United States Food and Drug Administration (FDA), the health authority that approves new medicine being prescribed for use in the United States. This means that it is not approved to treat patients with hemorrhagic cystitis or any other disease.

All prospective patients will undergo screening tests to determine if they are eligible to take part in the study.

If you qualify, the research study medicine (ALVR-105 or placebo) will be given to you by an infusion into a vein (IV injection). You will receive a second dose of research study medicine about two weeks after your first dose.

Note: This is only a partial description of treatment. Please contact the Robert H. Lurie Comprehensive Cancer Center of Northwestern University if you are interested in the trial.

The purpose of this study is tocompare the two approaches for monitoring pancreatic cysts. The doctors want tosee if less frequent monitoring is better or worse than more frequentmonitoring for patients with pancreatic cysts.

This study has 2 study groups:

Group 1

Participants in this group willget less frequent monitoring. Participants will receive an MRI or CT imagingscan at the beginning of the study and repeat the scan 1 year after joining thestudy. If the scans show normal results, scans will be repeated every 2 years.If the scans show abnormal results, participants will receive an endoscopicultrasound.

Group 2

Participants in this group willget more frequent monitoring. Participants will receive an MRI or CT imagingscan at the beginning of the study. . The frequency of repeat imaging couldrange from every 6 months to every 2 years, based on the size of theparticipant's pancreatic cyst.

Participants will be enrolled forup to five years.

Eligible patients will undergo craniotomy for tumor resection. During the tumor resection and when possible, an initial low dose of albumin-bound paclitaxel will be given following sonication. In select patients, the sonication procedure may occur immediately after the test dose of chemotherapy is administered. The sonication device will be implanted at the end of the procedure. In phase 1, about two weeks after surgery, patients will undergo sonication and albumin-bound paclitaxel administration with MRI to quantify extent of blood brain barrier opening. Sonication and administration of albumin-bound paclitaxel will continue every 3 weeks until disease progression. The planned albumin-bound paclitaxel starting dose is 40 mg/m2, to be escalated in the absence of significant toxicity up to 260 mg/m2. Blood samples for circulating tumor DNA will also be collected before and after each sonication. In phase 2, pre-sonication carboplatin at AUC 5 will be added to the regimen, with a safety run-in for the first 6 patients.

This study is being done to answer the following questions: 1) will neck and shoulder function and discomfort be better if you have a procedure called sentinel lymph node (SLN) biopsy instead of the usual surgery for this type of cancer; and 2) is SLN biopsy the same as the usual surgery in extending the time you have without cancer returning? The usual approach is defined as care most people get for this cancer.

The purpose of this study is to determine whether Gemcitabine and Nab-paclitaxel or 5-Fluorouracil,

Leucovorin, and Liposomal Irinotecan are more effective treatments for vulnerable patients

over the age of 70 with newly diagnosed metastatic pancreatic cancer (mPCA).

These drugs are already approved by the FDA for use in pancreatic cancer. But, it is unknown

which combination is the most effective for vulnerable mPCA patients over the age of 70.

This study will help the study doctors find out which approach is better at prolonging the life

of patients over 70 with mPCA. To determine this, the study doctors will be looking to see which

of the two approaches shows better results.

Participants who participate will be randomized to either get Gemcitabine and Nab-paclitaxel

every other week or 5-Fluorouracil, Leucovorin, and Liposomal Irinotecan every other week.

This study has 2 study groups.

Group 1 (Arm A)

Participants in this group will get the combination treatment of Gemcitabine and Nab-paclitaxel.

Group 2 (Arm B)

Participants in this group will get the combination treatment of 5-Fluorouracil, Leucovorin,

and Liposomal Irinotecan.

Your doctor will continue to follow your condition for up to 2 years after you start the study,

and watch you for side effects and monitor your cancer.

Hepatocellular carcinoma (HCC) is the most common form of liver cancer, making up approximately 90% of all liver cancers. It is the fourth largest contributor to cancer-related deaths worldwide. HCC is considered to be a complex tumor. Despite recent drug approvals for HCC, it has become clear that only some populations of patients benefit from certain drugs. This leads researchers to suspect that treatment for HCC would be more effective if we could match specific characteristics of a patient’s tumor with a drug that targets them best. Genomic analysis using an FDA-approved method called Next Generation Sequencing (NGS) could be used to potentially help physicians make such treatment decisions. The purpose of this study is to see how long patients will benefit if genomic analysis of their tumors is used to recommend more targeted treatments for HCC from a number of FDA-approved drugs.

This study isbeing done to answer the following question:

Can participantswith HER2-positive breast cancer who have no cancer remaining at surgery(either in the breast or underarm lymph nodes) after 12 weeks of chemotherapyand two HER-targeted therapies eliminate further chemotherapy after surgery?

This would be adecrease in the total number of chemotherapy drugs and the amount ofchemotherapy typically received to treat this type of cancer. We are doing thisstudy because we want to find out if this approach can enable you to take fewerchemotherapy drugs than the usual approach for your type of breast cancerwithout compromising your outcome. The usual approach is defined as care mostpeople get for HER2-positive breast cancer. Usual treatment includes additional chemotherapy drugs that might not benecessary, since the HER2-targeted drugs are so effective.

The names of thestudy drugs involved in this study are:

• Paclitaxel (also called Taxol). Thisis chemotherapy. [Alternativechemotherapy drugs allowed in the trial include docetaxel (also called Taxotere)or nab-paclitaxel (also called Abraxane)].

• Trastuzumab (alsocalled Herceptin). This is HER2-therapy.

• Pertuzumab (also called Perjeta).This is HER2-therapy.

All chemotherapy drugs will be givenintravenously through vein for 4 cycles. A cycle consists of 3 weeks. Before surgery, paclitaxel will be givenweekly for 12 weeks; pertuzumab will be given once every cycle; and trastuzumabonce every cycle or once weekly for 12 weeks. Alternatives to paclitaxel include docetaxel that will be given once percycle or nab-paclitaxel that would be given weekly for 12 weeks.

The purpose of this Managed Access Program(MAP), which is an intermediate size patient

population Expanded Access, is to allowtreatment with tisagenlecleucel (CTL019) for eligible

patients diagnosed with B-cell acutelymphoblastic leukemia (ALL) or large B-cell lymphomas who meet all of thefollowing criteria: are 1) consistent with the approved prescribing information,2) unable to receive commercially manufactured product due to failure of the incomingapheresis material to meet acceptance specifications or final outgoing productto meet the commercial release specifications or other specification within theprescribing information, and 3) where no overwhelming safety concerns has beenidentified for manufacture and release of the out of specification product.

Participation inthis treatment plan involves an experimental approach called gene transfer forALL or large B-cell lymphoma that involves cells in your blood called B cells(your tumor cells and also normal antibody-producing cells). During thistreatment, some of your own white blood cells (T cells) will be taken andchanged to turn against your tumor cells. T cells from your body will bechanged in a way that may allow them to identify and kill your tumor cells.This change may allow your T cells to go to the tumor cells, turn"on" and potentially kill the tumor cells. The modification is doneby gene transfer and results in a genetic change to your T cells. This mayallow the changed T cells to recognize your tumor cells but also normalantibody-producing cells called B cells. These changed cells are calledtisagenlecleucel cells.

If you are eligible andchoose to participate in this MAP, you will be asked to come to the doctor’soffice/clinic/study site at least 3 times in order to make sure you areeligible to receive the tisagenlecleucel cells, and to prepare you for theexperimental treatments. Once you receive the tisagenlecleucel cells, acaregiver, relative, or friend should be in your presence at all times for thefirst 10 days to monitor your well-being and contact your study physician incase of fever or changes in your condition. If you become ill, immediatelycontact your study physician. Additionally, you may be required to spend about4 weeks after you have received tisagenlecleucel cells in close proximity tothe trial treatment center while the doctor and study team see how thetreatment is working and monitor your safety.

Note:This is only a partial description of treatment. Please contact the Robert H.Lurie Comprehensive Cancer Center of Northwestern University if you areinterested in this Managed Access Plan (MAP).

The purpose of this study is to compare theusual treatment alone to adding immune system activating therapy, Pembrolizumab(MK-3475), to the usual treatment. This study will help the study doctors findout if this different approach is better than the usual approach. To decide if it is better, the study doctorswill be looking to see if the addition of pembrolizumab results in fewerdetectable leukemia using new methods.

Pembrolizumab (MK-3475), is already approvedby the FDA for use in several cancers, including advanced or metastaticsmall-cell and non-small cell lung cancer, melanoma, head and neck cancer,urothelial cancer, hepatocellular carcinoma, gastric cancer, among others. However, Pembrolizumab (MK-3475) is notapproved by the FDA or known to be safe for use in AML either alone or incombination with standard chemotherapy.

This study has 2 study groups. You will be putinto a group by chance. You will have anequal chance of being in Group 1 or Group 2

Group 1

Participants in group 1 will get the usualstudy drugs, cytarabine on Days 1-7 and either daunorubicin or idarubicin onDays 1-3. If you have evidence ofresidual leukemia in the bone marrow at Day 14, you will receive a second roundof the first part of therapy (5+2 chemotherapy), which means cytarabine on Days1-5 and either daunorubicin or idarubicin on Days 1-2. If you have a complete remission after thefirst part of therapy, you will continue with the second part of therapy thatconsists of up to four cycles of high dose cytarabine. If you remain in complete remission aftersecond part of therapy, you will be monitored without further therapy for up to3 years. If you proceed with atransplant, you will forgo any remaining protocol-defined therapy.

Group 2

Participants in group 2 will get the usualstudy drugs, cytarabine on Days 1-7 and either daunorubicin or idarubicin onDays 1-3. If you have evidence ofresidual leukemia in the bone marrow at Day 14, you will receive second dose ofthe first part of therapy (5+2 chemotherapy), which means cytarabine on Days1-5 and either daunorubicin or idarubicin on Days 1-2. Regardless of your bone marrow findings onDay 14, you will receive Pembrolizumab (MK-3475) IV on Day 8. If you have a complete remission after thefirst part of therapy, you will continue with the second part of therapy thatconsists of up to four cycles of high dose cytarabine with Pembrolizumab(MK-3475). If you remain in completeremission after the second part of therapy, you will be monitored withoutPembrolizumab (MK-3475) therapy on Day 1 of each 21-day cycle for up to 2years. If you proceed with a transplant,you will forgo any remaining protocol-defined therapy.

Almost allpatients with relapsed and refractory Hodgkin lymphoma require additionaltreatment. Typical treatments for relapsed or refractory Hodgkin lymphoma inthe United States can include additional chemotherapy regimens such asbrentuximab vedotin, or nivolumab. Webelieve that the addition of entinostat to pembrolizumab may provide benefit tothese patients and without having the need to undergo a stemcell transplant ( SCT)

Pembrolizumab has already been approved by theUS Food and Drug Administration (FDA) to treat relapsed or refractory classicalHodgkin lymphoma and other cancers. The combination of Entinostat andPembrolizumab has been tested in patients with lung cancer and has been foundto be safe.

The purpose of this study is for the study doctors to learn if miRNA 371 is useful for predicting relapse

in patients with germ cell cancer. A germ cell tumor is a type of cancer that occurs in the ovaries (for females) or the testes (for males). This tumor may also be found in the pelvis along the tailbone, the chest, the abdomen and in other structures of the body, generally along the midline of the body.

A sample of your blood will be collected during regular clinic visits to look for the presence of a tumor marker called miRNA 371. The study doctors do not know if the test is as good as the usual care (tumor scans and bloodwork) in predicting when cancer will return (relapse) in patients with germ cell cancer. If better, this blood test could change the way patients are monitored for relapse in the future.

If you decide to take part in this study, an extra tube of blood will be collected during your regular clinic visits for miRNA 371

analysis for up to 3 years from enrollment into the study.

This study is being done to answer the following question:

Can we increase the chance of your pancreatic cancer staying away by giving you chemotherapy before and after surgery?

We are doing this study because we want to find out if this approach is better or worse than the usual approach for your pancreatic cancer. The usual approach is defined as care most people get for removable pancreatic cancer.

The purpose of this study is to test the safety of the treatment with the copanlisib and olaparib

doublet combination, and the copanlisib, olaparib and MEDI4736 (durvalumab) triplet combination.

This study tests different doses of each combination treatment to see which dose is safest for people.

Another purpose of this study is for the doctors to learn if and how your genes can influence how you

respond to these specific drug combinations.

If you decide to take part in this study, you will either get the study drugs copanlisib and olaparib

in a doublet combination, or you will get the triplet combination of copanlisib, olaparib,

and MEDI4736 (durvalumab), until your disease gets worse or the side effects become too severe.

After you finish the study treatment, your doctor will continue to follow your condition

every 3 to 6 months via phone calls for up to 2 years, and will set up clinic visits as needed,

in order to watch you for side effects and cancer progression.

About the Study

Opt2Move is a 6-month smartphone-based study to help adolescent and young adult cancer survivors become more active.

What’s involved?

Assessments

Complete before starting study and at 3 and 6 months:

• 45-min online survey
• Wear activity monitor 24/7 for 7 days
• You will be compensated for assessment completion

Physical Activity Program

All Participants

• Receive Fitbit, Opt2Move app, exercise prescription, 15-min orientation call
• Track physical activity with Fitbit and use Opt2Move app daily
• Additionally, you may receive 0-4 additional Opt2Move features focused on mindfulness and/or social support.

How can I learn more?

For questions: Phone: 312-503-3465; Email: O2M@nm.org

To complete online screening: https://redcap.link/O2M

The purpose of this research is to determine whether radiotherapy after surgery to remove a breast cancer can help decrease the number of circulating tumor cells (CTCs) in the blood. Circulating tumor cells are cancer cells that are shed from the tumor into the blood stream and are believed to be one of the first indicators that breast cancer cells may remain after surgery. Approximately 20% of women with early-stage breast cancer can be found to have CTCs in a small sample of blood taken several weeks after surgery. Radiotherapy is used after surgery to remove a breast cancer in order to sterilize any cancer cells that may be remaining in the breast. It is not known if radiotherapy can help decrease or eliminate CTCs that are found in the blood. This study aims to find out if testing for CTCs can be clinically useful for guiding radiotherapy treatment decisions. Another aim of this study is to evaluate whether CTCs can be used to measure the effectiveness of radiotherapy in an individual patient.

This is a Phase 2anonrandomized, open-label, multicenter study to be conducted concurrently in 2Parts (Parts A and B). Both parts are designed to evaluate safety,tolerability, and efficacy of the combination therapy of intravenous (IV)DKN-01 and tislelizumab ± CAPOX in G/GEJ adenocarcinoma patients. Treatmentcontinues in repeating 21-day cycles until patient meets criteria fordiscontinuation or is no longer deriving clinical benefit. Parts A and B willbe enrolled concurrently. Two doses of DKN-01 will be evaluated in Part B (PartB1 and Part B2)

This study is being done to learn how the microbiome evolves through stem cell transplantation, how it can be shaped by socioeconomic status, the neighborhoods that people reside in, and their diet, as well as certain clinical factors (such as antibiotic usage). Study participants will be asked to provide a saliva sample and complete a questionnaire.

• To test the safety of Q702 and see what effects (good and bad) it has on you and your cancer.
• To find the highest dose of Q702 that can be given without causing serious side effects when treatment is given every day for 7 days, followed by 7 days of no treatment, repeated two times during a 28-day cycle.
• To find the dose of Q702 that should be used in future studies.
• To evaluate what the human body does and how the body reacts to Q702.

This research is being performed because improvements are needed in the treatment of patients with cancer.

The purpose of this study is to compare the usual treatment of SRS alone to SRS plus HA-WBRT

(whole brain radiation therapy with hippocampus avoidance) and memantine for patients with cancer

that has spread to the brain and come back in other areas of the brain after earlier treatment with SRS.

The addition of HA-WBRT and memantine to the usual treatment could better control your brain cancer.

This study will help the study doctors find out if this different approach is better, the same,

or worse than the usual approach.

Memantine is FDA approved for treating dementia and is commonly used off-label

(that is, for a purpose for which it is not FDA approved) for patients receiving whole-brain

radiation therapy for cancer that has spread to the brain.

This study has 2 study groups. You will be told which group you are in.

Group 1

If you are in this group, you will get the usual treatment, SRS. In addition to the usual

SRS treatment, you will also receive HA-WBRT. You will also be given the drug memantine,

which has also been shown to preserve memory function. Memantine will be taken for up to 6 months.

Group 2

If you are in this group, you will get the usual treatment of SRS.

After you finish your treatment, your doctor and study team will watch you for side effects and

follow your condition. They will check you every 2 to 3 months for at least 1 year after you finish

SRS. If you are receiving memantine, your doctor will continue to see you in the clinic as needed.

The purpose of this expanded access protocol is to allow patients to receive lisocabtagene maraleucel T cells that did not meet all of the prespecified release criteria (nonconforming) to be used as a routine prescription drug. The study will evaluate the safety and effectiveness of this therapy through the collection of information.

Participation in this treatment plan involves receiving the nonconforming product and performing tests as part of your routine clinical care. The information or results from these evaluations will be collected for research purposes.

If you are eligible and choose to participate in this EAP, you will be asked to complete test as part of routine care, you will undergo lymphodepleting therapy (chemotherapy administered to help prepare your bone marrow and immune system to receive lisocabtagene maraleucel), and receive the nonconforming lisocabtagene maraleucel product through your vein as an intravenous (IV) infusion.

Approximately 3 months after receiving your nonconforming lisocabtagene maraleucel, your participation in this study will end.

Note: This is only a partial description of treatment. Please contact the Robert H. Lurie Comprehensive Cancer Center of Northwestern University if you are interested in the trial.

Participants ages 18 years or older who have high-risk prostate cancer will be enrolled into this study.

This study is being done to answer the following questions:

If you have high risk prostate cancer, a low gene risk score and plan to receive radiation therapy, is a shorter hormone therapy treatment as effective at controlling your cancer compared to the usual 24 month hormone therapy treatment?

If you have high risk prostate cancer, a high gene risk score and plan to receive radiation therapy, does adding two new hormone therapy drugs to the usual treatment increase the length of time without your prostate cancer spreading as compared to the usual treatment?

The study doctors want to find out if these approaches are better, similar, or worse than the usual approach for your type of prostate cancer.

This study has 4 study groups.

If you have a low Decipher risk score, you will be randomly assigned to one of these two study groups:

· Group 1: If you are in this group, you will get the usual approach, hormone therapy and radiation therapy, used to treat this type of cancer.

· Group 2: If you are in this group, you will get the usual radiation treatment and a shorter period of hormone therapy used to treat this type of cancer.

If you have a high Decipher risk score and/or positive pelvic node(s), you will be randomly assigned to one of these two study groups:

· Group 3: If you are in this group, you will get the usual approach, hormone therapy and radiation therapy, used to treat this type of cancer.

· Group 4: If you are in this group, you will get study drugs called apalutamide and abiraterone acetate with prednisone plus the usual approach (hormone therapy and radiation therapy) used to treat this type of cancer.

After you finish your study treatment, your doctor will continue to follow your condition for at least annually and watch you for side effects.

The purpose of this research study is to evaluate an investigational cell and gene treatment called MB-CART2019.1 that may help to eliminate cancer cells in subjects who have relapsed (responded to treatment but then returns) and/or refractory (has not responded to initial treatment) DLBCL. In order to produce the investigational treatment, white blood cells (T-cells) will be collected at the study center by a process called leukapheresis.

Participation in this study is for up to two years, and additionally subjects must enroll in the separate Gene Therapy Long-Term Follow Up protocol for 13 years (total study participation to equal up to 15 years).

The T‑cells (obtained from blood) will be modified in order for them to express molecules called chimeric antigen receptors (CARs) on their surfaces. When the modified cells, called CAR T‑cells, are reinfused into the body, the new receptors will enable them to bind onto specific antigens on cancer cells and by doing so destroy them. The CAR T-cells act as a “living drug” against your cancer cells.

Before your cells are reinfused, participants will first receive a conditioning regimen consisting of two chemotherapy drugs, fludarabine and cyclophosphamide. The conditioning regimen helps make room in the bone marrow for new blood stem cells to grow, and helps prevent rejection of the transplanted cells, as well as helps kill any cancer cells that are in the body.

Note: This is only a partial description of treatment. Please contact the Robert H. Lurie Comprehensive Cancer Center of Northwestern University if you are interested in the trial.

The purpose of this study is to compare the usual treatment of chemotherapy and radiation to adding MEDI4736 (durvalumab) immunotherapy to the usual treatment. This study will help determine if this different approach is better than the usual approach. To decide if it is better, the study doctors will be looking to see if the study approach increases the life of patients compared to the usual approach.

This immunotherapy drug,MEDI4736 (durvalumab), is already approved by the FDA for use in metastatic bladder cancer.

Participants who decide to take part in this study will either get chemotherapy and radiation for 6-8weeks, or will get MEDI4736 (durvalumab) immunotherapy in addition to chemotherapy and radiation for 6.5-8 weeks. Participants in the MEDI4736(durvalumab) Group 1 whose bladder cancer has responded (shrunk, gone away or remained stable) to treatment with chemotherapy, radiation and MEDI4736(durvalumab) will be offered more treatments with MEDI4736 (durvalumab) alone for up to 9 months.

Participants who are in the arm with chemotherapy and radiation, and whose cancer has responded, will be watched closely without any additional chemotherapy and radiation treatments. Participants whose cancer has not responded, may be offered surgery or some other treatment.

After study treatment is finished, participants will be followed by the study doctor for up to 3 years.

Participants 18 years or older who have metastatic melanoma, and the cancer has a change in the gene called the BRAF, and is not responsive to treatment with MEK and BRAF inhibitors will be enrolled.

This study has two phases. Phase 1 and Phase 2.

The purpose of Phase 1 is to test the safety of the study drug, tazemetostat, in combination with the usual treatment, dabrafenib and trametinib. This study tests different doses of tazemetostat with the usual dose of dabrafenib and trametinib to see which dose of tazemetostat is safest for people. Tazmetostatis not approved by the FDA for treatment of this type of cancer.

All people taking part in this study will get the same dose of the usual intervention, dabrafenib and trametinib. However, people in this study will get different doses of the study drug, tazemetostat. Once the highest safe dose is found, phase 1 of the study is stopped.

The purpose of Phase II is to compare the combination of tazemetostat, dabrafenib, and trametinib to tazemetostat alone. This study will help the study doctors find out if this different approach is better, the same, or worse than the usual approach. Another purpose of this study is for the study doctors to learn if a genetic test is helpful to decide if tazemetostat is more effective in patients whose cancer has an abnormal EZH2 gene. The combination of tazemetostat, trametinib, and dabrafenib, has not been administered together in patients and the combination of these agents are not FDA approved for the treatment of this type of cancer.

Participants who take part in this study will either get a combination of usual approach of dabrafenib and trametinib, and the study drug, tazemetostat or will get the study drug, tazemetostat alone, until their disease gets worse or the side effects become too severe.

The purpose of this study is to compare the early treatment(before you have symptoms) of venetoclax and obinutuzumab (V-O) to the usual treatment of V-O after you have symptoms. This study will help the study doctors find out if this different approach is better, the same, or worse than the usual approach. Another purpose of this study is to find out how early V-O treatment affects patients’ physical, social, and emotional well-being, compared to patients receiving the standard delayed V-O treatment.

The antibody, obinutuzumab, and the drug, venetoclax are already approved by the FDA for use in patients with previously untreated CLL or SLL. Most of the time these drugs are not used until a patient has symptoms that make treatment necessary.

Participants who decide to take part in this study will either get treatment with venetoclax and obinutuzumab (V-O) that starts before symptoms start (now), or participants will get treatment with venetoclax and obinutuzumab (V-O) that will start after symptoms start (later). For all patients, the treatment with V-O will continue for 12 months or until the cancer gets worse, or the side effects are too great.

After treatment is finished, participants will be followed for up to 10 years after enrollment.

The purpose of this study is to compare the usual treatment with T-DM1 alone toT-DM1 plus tucatinib. This study will help the study doctors find out if this different approach is better than the usual approach. T-DM1 is already approved by the FDA for use in patients with HER2-positive cancer. Tucatinib has not been FDA-approved to treat breast cancer.

Participants who decide to participate will either get treatment with T-DM1 and placebo (a pill that looks like the study drug but contains no medication) or T-DM1 and tucatinib, for up to 14 cycles, unless the breast cancer returns or the side effects become too severe.

After study treatment is finished, the study doctor will follow participants to watch for side effects and for signs of breast cancer returning. This may include a clinic visit every 6 months for 10 years.

Studyparticipants are being treated with Tumor Treating Fields (TTFields) formalignant glioma. The TTFields device uses low-intensity electrical fields totreat cancer, and this type of therapy can cause skin side effects, such asitching, sores, or infections. Researchers want to know if using clindamycingel and triamcinolone topical (on the skin) lotion before these side effectsoccur may be able to prevent their appearance, so that TTFields can be usedwith less need for interruptions

Patients with unresectable Hepatocellular carcinoma (HCC) with underlying Child-Pugh classB cirrhosis have no options for systemic therapy based on current guidelines and available evidence.The aim of this study is to determine the safety and efficacy of cabozantinib in the management of HCCin this patient population

The purposeof this study is to determine the effectiveness (how well the experimentaldrugs work) and safety of envafolimab, when given alone or in combination withipilimumab to patients with advanced or metastatic undifferentiated pleomorphicsarcoma (UPS) or myxofibrosarcoma (MFS) in order to stimulate the immune systemto attack cancer cells.

Undifferentiatedpleomorphic sarcoma (UPS) is a rare type of cancer that begins mostly in thesoft tissues of the body and myxofibrosarcoma (MFS) is a type of cancer thattypically appears as a slow-growing, painless lump on one of your legs or arms.

The main purposes of this study are to learn about the safety and profile of any side effects from the study drugs and to determine the highest, safe dose that can be given to patients with ovarian cancer and to look for signs that the study drugs can treat ovarian cancer

This study will look at the safety and tolerability of an investigational anticancer drug currently known as BGB-11417. In addition, this study also aims to look at the safety of BGB-11417 when given in combination with zanubrutinib (also known as BGB-3111).

BGB-11417 is made by BeiGene, Ltd. BGB-11417 is an experimental drug. This means that it has not been approved for treatment by the Food and Drug Administration (FDA) in the United States or other regulatory agencies outside the United States where the Sponsor seeks approval of BGB-11417. As of 04 February 2021, BGB-11417 as a single drug has been given to over 9 participants enrolled in this research study.

This study aims to determine the range of BGB-11417 doses that can safely be used, the safest dosing schedule to minimize side effects when first taking BGB-11417, what side effects may be experienced when taking this drug, how your body processes this drug, and if this drug is effective against your cancer.

Background:

More than 130 primary tumors of the central nervous system (CNS) have been identified. Most affect less than 1,000 people in the United States each year. Because these tumors are so rare, there are few proven therapies. This study will test whether the immunotherapy drug nivolumab is an effective treatment for people with rare CNS tumors.

Objectives:

To learn if stimulating the immune system using the drug nivolumab can shrink tumors in people with rare CNS (brain or spine) tumors or increase the time it takes for these tumors to grow or spread.

Eligibility:

Adults whose rare CNS tumor has returned.

Design:

Participants will be screened:

• Heart and blood tests
• Physical and neurological exam
• Hepatitis tests
• Pregnancy test
• MRI. They will lay in a machine that takes pictures.
• Tumor tissue sample. This can be from a previous procedure.

At the start of the study, participants will have blood tests. They will answer questions about their symptoms and their quality of life.

Participants will get nivolumab in a vein every 2 weeks for up to 64 weeks.

Participants will have monthly blood tests. Every other month they will have an MRI and a neurologic function test. They will also answer questions about their quality of life.

Genetic tests will be done on participants' tumor tissue. Participants will be contacted if any clinically important results are found.

After treatment ends, participants will be monitored for up to 5 years. They will have a series of MRIs and neurological function tests. They will be asked to report any symptoms they experience....

The purpose of this open-label research study is to assess the effectiveness and safety of once-daily buparlisib in combination with weekly paclitaxel compared to weekly paclitaxel alone in subjects with refractory, (a disease or condition which does not respond to previous forms of treatment) recurrent, or metastatic (disease that has returned or spread) head and neck cancer that has progressed after prior immunotherapy (treatment that uses the immune system to attack cancer, such as antiPD1/antiPDL1 treatments) with or without prior platinum-based chemotherapy.

The study will consist of the following parts:

•A preliminary (screening) period of up to 4 weeks (28 days) to determine eligibility

•A treatment period of up to 15 cycles (1 cycle is 21 days)

•End-of-treatment visit

•A follow-up visits 30 days after the end-of-treatment visit

•Continued follow-up to monitor health status every 3 months for up to 5 years

Participants will continue to receive the study drug until they are no longer benefiting, or experience unacceptable side effects or withdraw from the study.

Participants will be assigned into one of two study treatment groups:

•80 mg/m2/week paclitaxel intravenous infusion in combination with 100 mg/day buparlisib given orally in 21-day cycles

•80 mg/m2/week paclitaxel intravenous infusion

Study treatment assignment will be random. Participants will be assigned to the study treatment groups in a 2:1 ratio, which means 2 out of 3 subjects will be in the buparlisib group and 1 out of 3 subjects placed in the paclitaxel only study treatment group.

Note: This is only a partial description of treatment. Please contact the Robert H. Lurie Comprehensive Cancer Center of Northwestern University if you are interested in the trial.

The purpose of this research is to determine whether providing an individual polygenic risk score (PRS), in addition to the Breast Cancer Risk Assessment Tool (BCRAT) or Tyrer-Cuzick (IBIS) score, to women at high risk of breast cancer will improve their ability to make a better informed decision to accept preventive therapy and/or supplemental breast cancer screening.

Study participation involves: 2 separate visits at which you will be asked to complete surveys and blood draws; and 8 annual visits of which you will be asked to complete surveys remotely.

The purpose of this study is to assess if the use of a 3D imaging device called the Clarix Imaging Volumetric Specimen Imager (VSI) can help guide and assist surgeons in identifying and removing all positive margins while in the operating room for breast conservation surgery.

If you are undergoing breast conservation surgery and meet all criteria, the 3D imaging device, VSI, will be used to guide and assist the surgeon in identifying and removing all positive margins while in the operating room. The lumpectomy procedure will be performed per standard practice.

If eligible, the lumpectomy procedure will be performed per standard practice. Promptly after excision, the tumor specimen will be imaged using the VSI device to take additional 3D images of the removed tissue during the standard of care surgery.

During surgery, after the tumor has been removed, the investigators will use the VSI device to identify the margins on the main sample. The surgeon will use this information to remove additional tissue from the cavity. The surgeon will then complete the standard of care surgery according to standard of care practices which may include additional shaves of the remaining issue. The amount of tissue removed as a result of VSI-directed shaving will not be more than the amount that your surgeon would normally remove as part of standard of care.

Participants will be asked to come for a post-operative visit as per standard of care and will be followed-up up to 2 months after surgery.

Note: This is only a partial description of the study procedures. Please contact the Robert H. Lurie Comprehensive Cancer Center of Northwestern University if you are interested in the trial.

Dedifferentiated liposarcoma often has a protein called CDK4 that is over-active. Researchers think that abemaciclib (the study drug), which blocks CDK4, may slow or stop the growth of the liposarcoma tumors. This study is being done to see if the study drug can slow or prevent liposarcoma from growing. The US Food and Drug Administration (FDA) has not approved abemaciclib for liposarcoma, although it is approved for breast cancer. The use of abemaciclib in this study is considered investigational.

The main purpose of this study is to determine if the investigational drug, called DT2216, is safe, and to determine the anti-cancer activity. This is the first time that the study drug has been used in people.

The study will consist of the following parts:

•A preliminary (screening) period of up to 28 days to determine eligibility

•A treatment period of up to 1 year

•A follow-up visit 28 days after the last dose of drug

•Continued follow-up to monitor health status every 3 months for up to 2 years

Participants will continue to receive the study drug until they are no longer benefiting, or experience unacceptable side effects or withdraw from the study.

On the first day of the study treatment period (Day 1), the study doctor will perform some tests before participants receive the first dose of study drug. After these are completed, participants will receive a single dose of study drug by intravenous (IV) line on Day 1 and again on Day 4 each week for at least 4 weeks (this is known as 1 cycle of study treatment). During each cycle clinic visits, the study doctor will perform some tests to check for health status.

Note: This is only a partial description of treatment. Please contact the Robert H. Lurie Comprehensive Cancer Center of Northwestern University if you are interested in the trial.

The purpose of this study is to determine how safe, at what dose and how well TAK-007 works as a therapy in participants with worsened or refractory B-cell Non Hodgkin Lymphoma.

If you meet all the eligibility criteria for being in this study, the study consists of two parts:

Part 1: You will be given one of two dose levels to determine the safety and tolerability of TAK-007. The information from this part of the study will help the Sponsor determine what dose level to explore in a larger number of participants. Both doses expected to be safe.

Part 2: You will be given the recommended phase 2 dose, determined in part 1 of the study, to further evaluate the safety and effectiveness of TAK-007.

The purpose is to determine if mycophenolate motfetil (MMF) combine with temozolomide (TMZ) can stop glioblatoma.

Mycophenolate Mofetil is an antimetabolite immunosuppressant and is FDA approved for the prophylaxis of organ rejection in recipients of allogeneic kidney, heart or liver transplant, and is used in combination with other immunosuppressants.

Group S (Pre-surgical): Window of Opportunity Study, pre-operative MMF and temozolomide (TMZ)

Participants with suspected newly diagnosed or recurrent glioblastoma who plan to have surgical resection are eligible. Study treatment must begin within 7 days after registration. Group S will open in Part 1 after one participant in Group 1 has successfully completed the first dose level DLT period and subsequent DSMB review. The MMF dose for Group S will be adjusted each time DSMB has approved a subsequent dose escalation. The MMF dose for Group S will always be 1 dose level below the current enrolling dose level (the last safe dose level as indicated by the DSMB) in Group 1. Participants will have 5 days of pre-operative MMF (BID) and TMZ (200 mg/m2 QD)

Group 1 (Adjuvant): Adjuvant therapy+ MMF (dose escalation)

Four to six weeks after the completion of chemoradiation, participants will be registered to the study. Study treatment must begin within 7 days after registration. On study, participants will receive maintenance TMZ and MMF. Each maintenance cycle is 28 days long.

TMZ will be taken orally once a day on Days 1-5, at a dose of 150 mg/m2, for up to 6 cycles. On Cycles 2-6, the TMZ dose may be increased to 200 mg/m2 in the absence of toxicity. Starting Cycle 1 Day 1, MMF will be taken orally twice daily for up to 6 cycles (each cycle is 28 days). The dose of MMF will depend on the dose level each participant is accrued to. See MMF Dose Level table in Section 4.2. The DLT period for Group 1 is the duration of Cycle 1 (28 days), and 7 days thereafter.

Group 2 (Chemoradiation): RT + MMF for MGMT unmethylated tumors (dose escalation)

About 4 weeks after surgical resection, participants confirmed to have unmethylated glioblastoma will be registered and treated with concurrent MMF and TMZ (75 mg/m2 daily) and 6 weeks of focal radiation therapy (60 Gy). Study treatment must begin within 7 days after registration. MMF will be taken twice daily for the entire 6 week period of focal radiation therapy. The dose of MMF will depend on the dose level each participant is accrued to.

After radiation therapy, participants will start adjuvant treatment with TMZ. TMZ will be taken orally once a day on Days 1-5, at a dose of 150 mg/m2, for up to 6 cycles. On Cycles 2-6, the TMZ dose may be increased to 200 mg/m2 in the absence of toxicity

The DLT period for Group 2 is the duration of radiation therapy (6 week period), and 7 days thereafter.

Group 3 (Expansion): MMF during RT and during adjuvant phase. Enrollment to begin only AFTER the completion of groups 1 and 2.

About 4 weeks after surgical resection, participants will be registered and treated with concurrent MMF and 6 weeks of focal radiation therapy (60Gy) and concurrent TMZ at a dose of 75 mg/m2 daily. Study treatment must begin within 7 days after registration. After completion of chemoradiation, participants will go on to have adjuvant TMZ (at a dose of 150 mg/m2 on days 1-5 of each cycle, may be up to 200 mg/m2 during cycles 2-6) with concurrent twice-daily MMF for a total of 6 planned cycles (each cycle is 28 days). The dose of MMF during radiation therapy and during adjuvant treatment will be the RP2D determined in dose escalation Groups 1 and 2.

Optune® Device (Tumor Treating Fields) Concurrent use of the Optune® device (TTFields) is permitted, but not required for participation on this study. It’s use will be according to standard of care.

The purpose of this study is to:

• Test the safety of the study drugs, pembrolizumab/MK-3475 in combination with Bacillus Calmette-Guérin (BCG)

• See how well the drugs work

• See how the body handles pembrolizumab and BCG

• See how well pembrolizumab in combination with different doses of BCG works compared to BCG alone

• See if pembrolizumab helps patients getting BCG have a better quality of life

• See if pembrolizumab helps patients getting BCG live longer

Pembrolizumab has been approved for patients with certain types of bladder cancer; however, it has not been approved for your type of bladder cancer, and is therefore considered experimental in this study.

The purpose of this study is to see if using a combination of bevacizumab, atezolizumab, and erlotinib is safe and will cause your tumors to shrink.

The use of bevacizumab and atezolizumab in this study is considered investigational which means this combination has not been approved by the U.S. Food and Drug Administration (FDA) to treat kidney cancer. However, the FDA has given us permission to use bevacizumab and atezolizumab in this study.

The purpose of this study is to see how well transplant works in adults with a mismatched unrelated donor using stem cells from a donor’s blood. We’ll look at how well the transplant treats your disease, what the side effects may be, and what your life looks like after your transplant. The study will also help us give better care to future patients. This study treatment does not include any investigational drugs.

Before you begin the study, your doctor will review your test results to decide if it’s safe for you to be in the study. If you join the study, you will have tests and evaluations to closely watch your health and safety. Most of these tests and evaluations are considered part of the standard care you would get if you receive a transplant and weren’t in this study. You may have had some of them done already. Your study doctor will determine if any of these tests or procedures will need to be repeated for you to participate in the study. There are some surveys we will ask you to fill out before and after the transplant that are not part of routine care.

The medicines and procedures in this study are also standard for transplant. You may still receive these medicines and procedures if you are not part of the study and receive a transplant.

Transplant day

On your transplant day (Day 0), the donor cells will be given to you through your central line, like a blood transfusion. The cells will travel to your bone marrow where they will start to make healthy, new blood cells after several weeks.

After your transplant

Graft-versus-host disease (GVHD) is a common complication of transplant. It happens because of differences between the donated cells (graft) and your body’s cells (host). Your new cells from your donor might see your body’s cells as different and attack them. You’ll get standard medicines to lower your risk of getting graft versus host disease (GVHD). You’ll start these medicines around the time of your transplant, and continue taking them for many months afterwards. They may not completely prevent GVHD and you may need more medicines to treat GVHD if you develop it.

The Survey Research Group (SRG) team of the Center for Blood and Marrow Transplant Research (CIBMTR) will contact you to do the surveys 4 times during the 1 year you’re in the study. Each survey will take between 15 and 25 minutes to complete.

oBefore transplant

oAbout 3 months after transplant

oAbout 6 months after transplant

oAbout 1 year after transplant

Note: This is only a partial description of treatment. Please contact the Robert H. Lurie Comprehensive Cancer Center of Northwestern University if you are interested in the trial.

This research study is ultimately designed to evaluate a new drug called BNT152+153. Since this drug is a combination of two investigational drugs called BNT152 and BNT153, the sponsor must first evaluate each of the two drugs separately (called “monotherapy”). “Investigational” means that BNT152 and BNT153, whether given as monotherapy or combination therapy, are not approved by the United States (U.S.) Food and Drug Administration (FDA) or by any regulatory authority in the world.

In this research study, BNT152 monotherapy, BNT153 monotherapy, and BNT152+153 combination therapy will be tested in humans for the first time.

The overall purpose of this research study is to assess the safety and to establish a safe and effective dose of BNT152 and BNT153 when each is given alone (monotherapy) and when given in combination (BNT152+153). The study will also collect information about how well the drug(s) works against cancer.

Purpose

The purpose of this study is to determine if radiation therapy alone is as effective at controlling unfavorable intermediate risk prostate cancer, cancer compared to the usual combination of radiation and hormone therapy.

Who May be Eligible:

Some of the key eligibility criteria include:

· Cytologically or histologically confirmed diagnosis of adenocarcinoma of the prostate.

· Unfavorable intermediate risk prostate cancer

· Age ≥18 years

Note: This is only a partial list of eligibility criteria. Please contact the Robert H. Lurie Comprehensive Cancer Center of Northwestern University for complete screening information if you are interested in this clinical trial.

All prospective patients will undergo screening tests to determine if they are eligible to take part in the study.

The purpose of this study is to test any good and bad effects of the study drug called ruxolitinib. Ruxolitinib works by blocking a protein called JAK. JAK works along with another protein called STAT and is important for survival of many T or NK-cell lymphomas. By blocking JAK, ruxolitinib may cause T or NK-cell lymphomas to shrink.

The purpose of this study is to test any good and bad effects of the study drug, XmAb20717, and test how well it works on your type of cancer, anaplastic thyroid cancer (ATC) or Hurthle cell thyroid cancer (HCC). ATC is the most advanced and aggressive thyroid cancer. It is very rare and is found in less than 2% of patients with thyroid cancer. HCC is another aggressive form of thyroid cancer found in 5% of patients with thyroid cancer.

If the study requirements are met, the enrolled patient will be given the study drug, XmAb20717, as treatment. There will be 2 cohorts receiving treatment—patients with ATC and patients with HCC.

Each cycle of treatment will be 28 days (4 weeks), and the study drug will be administered on days 1 and 15 of each 28-day cycle. The treatment cycles may repeat until the patient has received treatment for 24 months (2 years).

After the last dose of the study drug, the study doctor will continue to watch the patient for side effects and follow the patient’s condition for up to 5 years.

The purpose of this study is to test the safety and tolerability of a drug called BAY 1895344 given with pembrolizumab and radiation. This study tests different doses of the drug and radiation to see which dose is safest for people as part of the combination treatment. There will be up to 37 people taking part in this study.

Pembrolizumab has already been approved by the FDA to treat your cancer. The combination of BAY 1895344, pembrolizumab, and radiation is not FDA-approved to treat your cancer. BAY 1895344 is not FDA-approved to treat your cancer or any cancer.

If the study requirements are met, the enrolled patient will be enrolled into one of the two parts of this study below:

· Dose escalation part: different patients will get different doses of the study drug BAY 1895344 and different doses of radiation, as well as the same doses of pembrolizumab

OR

· Dose expansion part: patients will receive the highest dose of BAY 1895344 with manageable side effects, along with pembrolizumab and radiation

The doctor and the study team will watch for side effects during the trial. Patients will also be followed for 5 years after starting the study.

This study is being done to collect, process, and store blood samples of plasma cell disorder patients. The collected blood samples will be used for research projects to study the abnormal plasma cells and compare the results to current tests being done. This will provide an opportunity to better understand how a patient is responding to treatment and to assess the stage of the patient’s disease.

This study will use different tests that are not FDA approved. This test is being studied as a less invasive way to monitor amount of disease in a patient (versus invasive bone marrow biopsy). Current blood tests show the levels of the product of the cancer cell - not the levels of the cells themselves. Sometimes the cancer cells do not make this product and can therefore go undetected in standard tests. This study will show the number of cells. These tests will help identify, and analyze circulating plasma cells (CPCs), which are cells that have escaped into the bloodstream (a characteristic of plasma cell disorders). We will also look at any plasma cell components, such as genes in the DNA and RNA. Part of your samples will be used for Next Generation Sequencing (NGS) to evaluate any changes in your genes. NGS is a useful tool that determines the sequence of your DNA.

The purpose of this study is to evaluate the effectiveness and safety of an investigational drug, unesbulin. This study drug is used to treat unresectable (can’t be removed with surgery) or metastatic (spread to other parts of the body), relapsed (has come back after treatment or refractory (did not respond to prior treatment) leiomyosarcoma along with Dacarbazine (DTIC). Dacarbazine is a drug that is United States Food and Drug Administration (FDA)-approved for the treatment of other types of cancer and recommended by the cancer treatment guidelines for sarcomas. Laboratory studies showed the combination of unesbulin and dacarbazine was significantly more effective than either agent alone in suppressing tumor growth.

If the study requirements are met, patients will be assigned to one of the two groupgs:

· Unesbulin in combination with Dacarbazine: Subjects will receive Unesbulin twice a week in 3-week study treatment cycles, and Dacarbazine once every 21 days

OR

· Placebo in combination with Dacarbazine: Subjects will receive placebo (pill with no active medicine) twice a week in 3-weeks study treatment cycles, and Dacarbazine once every 21 days.

Twice the number of the subjects will be in the unesbulin arm vs the placebo. As a result, you are more likely to be on the unesbulin group than the placebo group. After treatment, the study doctor will also call you every 3 months via telephone for up to 2 years to monitor your health.

In this research study, we are examining how effective talazoparib is in patients with metastatic breast cancer with a BRCA mutation in their tumor.

The U.S. Food and Drug Administration (FDA) has not approved talazoparib for your specific disease but it has been approved for metastatic breast cancer with a germline (inherited) BRCA mutation.

Talazoparib is a study drug that inhibits (stops) the normal activity of certain proteins called “poly (ADP-ribose) polymerases” also called “PARPs”. PARPs are proteins (made from genes which are part of your DNA) that are found in all normal and cancer cells that are involved in the repair of DNA. PARPs are needed to repair mistakes that can happen in DNA when cells divide. If the mistakes are not repaired, the defective cell will usually die and be replaced. Cells with mistakes in their DNA that do not die can become cancer cells. Cancer cells may be killed by a study drug, like talazoparib, that stops the normal activity of PARPs. In clinical trials, the use of talazoparib and other PARP inhibitors have shown that these drugs can reduce tumor size and slow tumor growth in some cancer patients with BRCA1 or BRCA2 mutations

This study is being done to answer the following question:

Can daratumumab-hyaluronidase reduce the level of MRD in T-ALL patients previously treated with chemotherapy?

We are doing this study because we want to find out if this approach is better or worse than the usual approach for your T-ALL. The usual approach is defined as care most people get for Acute Lymphoblastic Leukemia (ALL). The usual approach for patients who are not in a study is treatment with chemotherapy, and possibly stem cell transplant. Sometimes, combinations of these treatments are used. Currently there is no SOC treatment for MRD positive T ALL. Many patients if eligible would undergo stem cell transplant, but still have a high risk for T ALL relapse if MRD positive

The purpose of this study is to test the good and bad effects of the drug called daratumumab and hyaluronidase. Daratumumab and hyaluronidase could be effective in preventing your cancer from returning, but it could also cause side effects. The study doctors hope to learn if the study drug will be effective in treating patients with MRD positive T-ALL and preventing reoccurrence of your disease.

The purpose of this study is to test any good and bad effects of the study drug called Libtayo(cemiplimab) in patients with the diagnosis of Cutaneous Squamous Cell Carcinoma (CSCC,) when given before resection surgery. This investigational approach could shrink your cancer, but it could also cause side effects. Researchers hope to learn if the use of this drug before surgery will reduce the amount of cancer cells by at least 50% compared to the original amount in more than 40% of patients. Libtayo (cemiplimab) is FDA-approved to treat metastatic CSCC.

Cemiplimab will be administered as an IV infusion over 30 minutes in an outpatient setting. Cemiplimab will be used at a flat 350 mg IV dose every 21 days for a total of 9 weeks (or 12 weeks). One cycle is 21 days. After discontinuation of treatment, if the tumor is potentially resectable, the patient will proceed with surgical resection.

Note: This is only a partial description of treatment. Please contact the Robert H. Lurie Comprehensive Cancer Center of Northwestern University for complete description of treatment.

Patients with a primary invasive melanoma are recommended to undergo excision of the primary lesion with a wide margin. There is evidence that less radical margins of excision may be just as safe. This is a randomised controlled trial of 1 cm versus 2 cm margin of excision of the primary lesion for adult patients with stage II primary invasive cutaneous melanomas (AJCC 8th edition) to determine differences in disease-free survival. A reduction in margins is expected to improve patient quality of life.

Note: This is only a partial description of the study. Please contact the Robert H. Lurie Comprehensive Cancer Center of Northwestern University if you are interested in the trial.

This phase III trial compares denosumab to placebo for the prevention of breast cancer in women with a BRCA1 germline mutation. A germline mutation is an inherited gene change which, in the BRCA1 gene, is associated with an increased risk of breast and other cancers. Denosumab is a monoclonal antibody that is used to treat bone loss in order to reduce the risk of bone fractures in healthy people, and to reduce new bone growths in cancer patients whose cancer has spread to their bones. Research has shown that denosumab may also reduce the risk of developing breast cancer in women carrying a BRCA1 germline mutation.

Note: This is only a partial description of the study. Please contact the Robert H. Lurie Comprehensive Cancer Center of Northwestern University if you are interested in the trial.

This phase II trial tests whether the addition of radiation to the primary tumor, typically given with stereotactic ablative radiation therapy (SABR), in combination with standard of care immunotherapy improves outcomes in patients with renal cell cancer that is not recommended for surgery and has spread to other places in the body (metastatic). Radiation therapy uses high energy photons to kill tumor cells and shrink tumors. Stereotactic body radiation therapy uses special equipment to position a patient and deliver radiation to tumors with high precision. This method may kill tumor cells with fewer doses of radiation over a shorter period and cause less damage to normal tissue. Immunotherapy with monoclonal antibodies, such as nivolumab, ipilimumab, avelumab, and pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Axitinib, cabozantinib, and lenvatinib are in a class of medications called antiangiogenic agents. They work by stopping the formation of blood vessels that bring oxygen and nutrients to tumor. This may slow the growth and spread of tumor. Giving SABR in combination with standard of care immunotherapy may help shrink or stabilize the cancer in patients with renal cell cancer.

Note: This is only a partial description of the study. Please contact the Robert H. Lurie Comprehensive Cancer Center of Northwestern University if you are interested in the trial.

This Phase II/III trial will evaluate what kind of chemotherapy to recommend to patients based on the presence or absences of circulating tumor DNA (ctDNA) after surgery for colon cancer.

Note: This is only a partial description of the study. Please contact the Robert H. Lurie Comprehensive Cancer Center of Northwestern University if you are interested in the trial.

A Phase II/III Randomized Study of R-MiniCHOP with or Without CC-486 (Oral Azacitidine) in Participants Age 75 Years or Older with Newly Diagnosed Diffuse Large B Cell Lymphoma, Grade IIIB Follicular Lymphoma, Transformed Lymphoma, and High-Grade B-Cell Lymphomas with MYC AND BCL2 and/or BCL6 Rearrangements

This phase III trial compares the effects of nivolumab with chemo-immunotherapy versus chemo-immunotherapy alone in treating patients with newly diagnosed primary mediastinal B-cell lymphoma (PMBCL). Immunotherapy with monoclonal antibodies, such as nivolumab, may help the body's immune system attack the cancer, and may interfere with the ability of cancer cells to grow and spread. Treatment for PMBCL involves chemotherapy combined with an immunotherapy called rituximab. Chemotherapy drugs work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Rituximab is a monoclonal antibody. It binds to a protein called CD20, which is found on B cells (a type of white blood cell) and some types of cancer cells. This may help the immune system kill cancer cells. Giving nivolumab with chemo-immunotherapy may help treat patients with PMBCL.

This phase II/III trial tests whether adding trastuzumab and hyaluronidase-oysk (Herceptin HylectaTM) or pertuzumab, trastuzumab and hyaluronidase-zzxf (PhesgoTM) to the usual chemotherapy (paclitaxel and carboplatin) works to shrink tumors in patients with HER2 positive endometrial serous carcinoma or carcinosarcoma. Trastuzumab and pertuzumab are monoclonal antibodies and forms of targeted therapy that attach to specific molecules (receptors) on the surface of tumor cells, known as HER2 receptors. When trastuzumab or pertuzumab attach to HER2 receptors, the signals that tell the cells to grow are blocked and the tumor cell may be marked for destruction by the body's immune system. Hyaluronidase is an endoglycosidase. It helps to keep pertuzumab and trastuzumab in the body longer, so that these medications will have a greater effect. Hyaluronidase also allows trastuzumab and trastuzumab/pertuzumab to be given by injection under the skin and shortens their administration time compared to trastuzumab or pertuzumab alone. Paclitaxel is a taxane and in a class of medications called antimicrotubule agents. It stops cancer cells from growing and dividing and may kill them. Carboplatin is in a class of medications known as platinum-containing compounds. It works in a way similar to the anticancer drug cisplatin, but may be better tolerated than cisplatin. Carboplatin works by killing, stopping or slowing the growth of tumor cells. Giving Herceptin Hylecta or Phesgo in combination with paclitaxel and carboplatin may shrink the tumor and prevent the cancer from coming back in patients with HER2 positive endometrial serous carcinoma or carcinosarcoma.

Note: This is only a partial description of the study. Please contact the Robert H. Lurie Comprehensive Cancer Center of Northwestern University if you are interested in the trial.

The purpose of this study is to compare how safe and effective the investigational medicine, ANV419, is when given alone, or in combination with pembrolizumab or ipilimumab, which are medicines approved for use to treat melanoma.

This clinical study has three parts, and you will take part in one of these parts:

In Part 1, the goal is to understand how effective ANV419 is when given alone at two different doses.

In Part 2, the goal is to understand how safe different doses of ANV419 are when given in combination with pembrolizumab or ipilimumab, and to select the best dose of ANV419.

In Part 3, the dose of ANV419 selected from Part 2 will be used to further investigate the efficacy and safety of ANV419 in combination with pembrolizumab or ipilimumab.

IMGN853-0420 is a multicenter, open-label, phase 2 study of carboplatin plus mirvetuximab soravtansine followed by mirvetuximab soravtansine continuation in folate receptor-alpha positive, recurrent platinum sensitive, high-grade epithelial ovarian, primary peritoneal, or fallopian tube cancer following 1 prior line of platinum-based chemotherapy.

Note: This is only a partial description of the study. Please contact the Robert H. Lurie Comprehensive Cancer Center of Northwestern University if you are interested in the trial.

This is a randomized open-label study to evaluate the risk of MACE in patients with prostate cancer with defined high-risk cardiovascular disease who are appropriate to be treated either with

relugolix or leuprolide acetate for a planned duration of 12 months or more. This study will collect clinical and cardiovascular baseline risk factor data on these patients.

Colon and rectal cancer are cancers that involve the lowest part of the digestive system: the large intestine and the rectum. A colorectal cancer that has already spread to distant sites by the time it is diagnosed is referred to as metastatic (stage IV) colorectal cancer (CRC). In colorectal cancer, mutations in the BRAF gene are present in approximately 10% of patients with metastatic disease. Outcomes in these patients are poor relative to patients with non-BRAF mutated colon cancer. Encorafenib and cetuximab are standard of care therapy for metastatic colorectal cancer (CRC) patients who have disease progression (worsening of disease) after a previous line of therapy. Addition of hydroxychloroquine (HCQ) with encorafenib has shown to overcome the tumor’s resistance to encorafenib in laboratory studies. This study examines adding hydroxychloroquine to encorafenib and cetuximab in patients with worsening metastatic colon cancer on previous therapy. HCQ is an oral drug which is approved by the Food and Drug Administration (FDA) for other indications such as for treatment of uncomplicated malaria, preventive against malaria in select geographic regions, and for treatment of rheumatoid arthritis, systemic lupus erythematosus, and chronic discoid lupus erythematosus in adults. It is not currently FDA approved for the indication to be investigated in this study. As such, hydroxychloroquine will be the drug to be investigated (investigational drug) in this study in combination with encorafenib and cetuximab. Another drug named Panitumumab is also FDA approved for treatment of metastatic CRC in combination with other standard therapy. Panitumumab may also be used instead of Cetuximab in the above-mentioned treatment combination, depending on the choice of your doctor.

The purpose of this research study is to evaluate how CGT9486 (also known as bezuclastinib) plus sunitinib affects gastrointestinal stromal tumor (GIST) compared to just treatment with sunitinib along. You may participate in this study if you have received prior therapy with imatinib only and no other anticancer drug for GIST, and no other tyrosine kinase inhibitors (TKIs).

Participants will receive study treatment during 28-day study treatment cycles. The total number of study treatment cycles you may have will depend on how you respond to your study treatment. If you respond well, meaning your GIST does not progress or become worse, you may continue to receive treatment in 28-day cycles for a year, or longer. If your GIST progresses, meaning it grows, spreads, or gets worse, you will no longer receive treatment with the study drug and the study doctor will review other treatment options that may be available to you outside the study. Once you have stopped taking study drug, and all safety and imaging studies are completed, you will be contacted every 3-6 months to see how you are doing for up to 5 years, or until the study is over, whichever happens first. This follow-up can be done over the phone or by other electronic means.

The primary objective is to estimate the Overall Response Rate (ORR) of treatment with CPI-613 plus HCQ and, depending on the cohort and indication, either 5-FU or gemcitabine.

Under this protocol, patients in cohorts 1 and 2 will be treated with combination of 2000 mg/m2 CPI-613 Day 1 and Day 15, plus 2400 mg/m2 Fluorouracil (5-FU) IV infusion over 46 hours Day 1 and Day 15, plus 400 mg hydroxychloroquine (HCQ) PO BID over 28-day cycles.

Patients in cohort 3 will be treated with combination of 2000 mg/m2 CPI-613 Day 1 and Day 15 plus 400 mg HCQ PO BID and, depending on indication, either 1000 mg/m2 gemcitabine or 2400 mg/m2 5-FU.

Note: This is only a partial description of the study. Please contact the Robert H. Lurie Comprehensive Cancer Center of Northwestern University if you are interested in the trial

This phase III trial compares the addition of stereotactic radiosurgery before or after surgery in treating patients with cancer that has spread to the brain (brain metastases). Stereotactic radiosurgery is a type of radiation therapy that delivers a high dose of radiation only to the small areas of cancer in the brain and avoids the surrounding normal brain tissue. Surgery and radiation may stop the tumor from growing for a few months or longer and may reduce symptoms of brain metastases.

Note: This is only a partial description of the study. Please contact the Robert H. Lurie Comprehensive Cancer Center of Northwestern University if you are interested in the trial.

The purpose of this study is to see if sacituzumab govitecan can improve lifespans of patients with advanced TNBC and their tumor does not grow or spread when compared to chemotherapy (paclitaxel, or nab-paclitaxel, or the combination of gemcitabine and carboplatin), a commonly used treatment for previously untreated advanced TNBC

This phase II trial tests whether cabozantinib with or without atezolizumab works to shrink tumors in patients with papillary kidney cancer that has spread to other places in the body (metastatic). Cabozantinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Immunotherapy with monoclonal antibodies, such as atezolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving cabozantinib with atezolizumab may prevent papillary kidney cancer from growing or spreading compared to cabozantinib alone.

Note: This is only a partial description of the study. Please contact the Robert H. Lurie Comprehensive Cancer Center of Northwestern University if you are interested in the trial.

This phase II/III trial compares the addition of radiation therapy to the usual treatment (immunotherapy with or without chemotherapy) versus (vs.) usual treatment alone in treating patients with non-small cell lung cancer that has spread to nearby tissue or lymph nodes (advanced) or has spread to other places in the body (metastatic) whose tumor is also negative for a molecular marker called PD-L1. Stereotactic body radiation therapy (SBRT) is a type of radiation therapy that uses high energy x-rays to kill tumor cells and shrink tumors. This method uses special equipment to position a patient and precisely deliver radiation to tumors with fewer doses over a shorter period and may cause less damage to normal tissue than conventional radiation therapy. Immunotherapy with monoclonal antibodies, such as nivolumab, ipilimumab and pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Chemotherapy drugs, such as carboplatin, pemetrexed, paclitaxel and nab-paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. The addition of radiation therapy to usual treatment may stop the cancer from growing and increase the life of patients with advanced non-small cell lung cancer who are PD-L1 negative.

SL03-OHD-105 is an open-label, multicenter, phase 1b trial designed to evaluate SL-172154 administered in combination with pegylated liposomal doxorubicin (PLD) or mirvetuximab soravtansine (MIRV) in patients with platinum resistant ovarian cancer. Approximately 102 participants will be enrolled in this study in two phases: dose escalation and dose expansion.

Note: This is only a partial description of the study. Please contact the Robert H. Lurie Comprehensive Cancer Center of Northwestern University if you are interested in the trial.

This is a multi-center, open-label Phase 2 study designed to evaluate the efficacy and safety of BA3021 in PD-1/L1 failure patients with ROR-2 expression in recurrent or metastatic squamous cell carcinoma of the head and neck.

Note: This is only a partial description of the study. Please contact the Robert H. Lurie Comprehensive Cancer Center of Northwestern University if you are interested in the trial.

This phase I trial investigates the side effects of cabozantinib and nivolumab in treating patients with cancer that has spread to other places in the body (advanced) and who are undergoing treatment for human immunodeficiency virus (HIV). Cabozantinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Immunotherapy with monoclonal antibodies, such as nivolumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving cabozantinib and nivolumab may shrink or stabilize cancer in patients undergoing treatment for HIV.

Note: This is only a partial description of the study. Please contact the Robert H. Lurie Comprehensive Cancer Center of Northwestern University if you are interested in the trial.

This study is being done to answer the following question: Can we lower the chance of pNET coming back by giving chemotherapy after surgery? We are doing this study because we want to find out if this approach is better or worse than the usual approach for patients that have had surgery for pNET. The usual approach is defined as care most people get after surgery for pNET.

If you decide to take part in this study, you will either get the study drugs capecitabine and temozolomide for up to four months or you will receive the usual approach of observation only. Observation means you will not receive treatment for pNET. After the first four months, your doctor will continue to follow your condition for 5 years, watch you for side effects, and see if your tumor comes back. During this time you will need to visit the clinic every 6 months for the first 3 years, then once every 12 months for 2 more years.

The purpose of this study is to collect and store tumor tissue samples and clinical data from participants with any type of sarcoma, obtained when participants undergo routine biopsy and/or surgery, for use in future research. Participants will be asked to allow for blood, tissue and archival tissue samples, and clinical data, to be used for this biorepository. Samples will only be collected during standard of care procedures. Additional blood will be requested at the time of standard of care labs. Leftover tissue will be requested from patients’ standard of care biopsy or surgery. Information related to cancer and its response to therapy, including pathology and radiology results, will be collected.

Note: This is only a partial description of the study. Please contact the Robert H. Lurie Comprehensive Cancer Center of Northwestern University if you are interested in the trial.

This is an open label Phase 1b/2 study to evaluate the efficacy and safety of ACR-368 as monotherapy or in combination with low dose gemcitabine in participants with platinum-resistant ovarian carcinoma, endometrial adenocarcinoma, and urothelial carcinoma based on Acrivon's OncoSignature® test status.

Note: This is only a partial description of the study. Please contact the Robert H. Lurie Comprehensive Cancer Center of Northwestern University if you are interested in the trial.

The purpose of this study is to see if sacituzumab govitecan in combination with pembrolizumab can improve lifespans of patients with advanced, PD-L1 positive TNBC and their tumor does not grow or spread when compared to pembrolizumab in combination with chemotherapy (paclitaxel, or nab-paclitaxel, or the combination of gemcitabine and carboplatin), a commonly used treatment for previously untreated advanced TNBC.

• Sacituzumab govitecan (Trodelvy®) is currently approved by the United States (U.S.) Food and Drug Administration (FDA) and other regulatory agencies for previously treated advanced TNBC. It is also approved by the U.S. FDA for the treatment of patients with bladder cancer and cancers of the urinary tract.

• Pembrolizumab, is approved by the U.S. FDA and other regulatory agencies for the treatment of certain types of TNBC. It is also approved for the treatment of several different types of other cancers.

The combination of sacituzumab govitecan and pembrolizumab has not been approved by any health authorities for previously untreated advanced TNBC.

This is a randomized, open-label study.

Participants will be randomly assigned to receive either the experimental treatment, sacituzumab govitecan in combination with pembrolizumab, OR 1 of the following 3 standard chemotherapy treatment regimens chosen by the doctor:

• Pembrolizumab in combination with paclitaxel

• Pembrolizumab in combination with nab-paclitaxel

• Pembrolizumab in combination with gemcitabine with carboplatin

This study will evaluate erdafitinib administered via an intravesical delivery system for both NMIBC and MIBC. The TAR-210 intravesical delivery system has been developed to provide

continuous intravesical drug delivery for prolonged periods over multiple voiding cycles, thereby minimizing the number of intravesical instillations required and providing sustained drug exposure at the tumor site while minimizing systemic exposure and improving tolerability.

This phase I/Ib trial tests the safety and best dose of ipatasertib in combination with the usual treatment approach using chemotherapy together with radiation therapy ("chemo-radiation") in patients with stage III-IVB head and neck cancer. Ipatasertib is in a class of medications called protein kinase B (AKT) inhibitors. It may stop the growth of tumor cells and may kill them. Cisplatin which is a chemotherapy used in this trial is in a class of medications known as platinum-containing compounds. It works by killing, stopping or slowing the growth of cancer cells. Radiation therapy uses high energy to kill tumor cells and shrink tumors. Giving ipatasertib in combination with chemo-radiation may be better than chemo-radiation alone in treating patients with advanced head and neck cancer.

Note: This is only a partial description of the study. Please contact the Robert H. Lurie Comprehensive Cancer Center of Northwestern University if you are interested in the trial.

This is a first-in-human, open label, multicenter study to assess the safety, tolerability, pharmacokinetics, pharmacodynamics, and the preliminary antitumor activity of BDTX-1535 in patients with GBM or NSCLC harboring sensitive EGFR alterations and who have disease progression following standard of care

Note: This is only a partial description of the study. Please contact the Robert H. Lurie Comprehensive Cancer Center of Northwestern University if you are interested in the trial.

Patients will be centrally allocated in a randomized fashion (3:1:1:3) to receive either:

• Arm 1: nemvaleukin and pembrolizumab combination therapy

• Arm 2: pembrolizumab monotherapy

• Arm 3: nemvaleukin monotherapy

• Arm 4: Investigator’s choice chemotherapy. Options for protocol-specific Investigator’s choice chemotherapy include one of the following: pegylated liposomal doxorubicin (PLD), paclitaxel, topotecan, or gemcitabine. The Investigator will pre-select the Investigator’s choice treatment before the randomization of each patient

Note: This is only a partial description of treatment. Please contact the Robert H. Lurie Comprehensive Cancer Center of Northwestern University if you are interested in the trial.

This phase II trial tests whether nivolumab in combination with cabozantinib works in patients with mucosal melanoma. Immunotherapy with monoclonal antibodies, such as nivolumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Cabozantinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It works by blocking the action of an abnormal protein that signals tumor cells to multiply. This helps stop the spread of tumor cells. Giving nivolumab in combination with cabozantinib could prevent cancer from returning.

Note: This is only a partial description of the study. Please contact the Robert H. Lurie Comprehensive Cancer Center of Northwestern University if you are interested in the trial.

This study is being done to answer the following question: Which standard therapy is better for controlling your cancer for a longer period of time? We are doing this study because we want to find out which approach is better or worse for your advanced pancreatic neuroendocrine cancer. The usual approach is defined as care most people get for advanced pancreatic neuroendocrine cancer.

If you decide to take part in this study, you will either get lutetium Lu 177 dotatate, a radioactive drug given through your vein, for up to 8 months, or you will get the drugs temozolomide and capecitabine, as tablets you take by mouth, for up to 12 months.

After you finish your treatment, your doctor will continue to follow your condition at clinic visits and watch you for side effects. If you finish or choose to stop your treatment before your cancer gets worse, they will check on you every 3 months at clinic visits until your cancer gets worse or you start a different treatment. If your cancer gets worse or you start a different cancer treatment, they will check on you every 6 months by phone or medical record for a maximum of 8 years starting from the day you enrolled on the study.

The purpose of this study is to learn if the study drug called Lutetium-177 PSMA I&T is safe and effective in patients with castration-resistant metastatic prostate cancer.

The study is divided into 2 phases, a Safety Lead-In phase and a randomized perioperative phase. In the Safety Lead-In Phase, the recommended combination dose (RCD) of vorasidenib will be determined. In the Randomized Perioperative Phase, the Lymphocytes infiltration in tumors will be evaluated following pre-surgical treatment with vorasidenib and pembrolizumab combination, compared to untreated control tumors. Prior to surgery, participants will be randomized to receive vorasidenib at the RCD in combination with pembrolizumab, or vorasidenib only, or no treatment (untreated control group). Following surgery, participants will have the option to receive treatment with vorasidenib in combination with pembrolizumab in 21-day cycles.

Study treatment will be administered until participant experiences unacceptable toxicity, disease progression, or other discontinuation criteria are met.

DRUG GLSI-21-01: A Randomized, Multicenter, Placebo-controlled, Phase 3 study to Evaluate the Efficacy and Safety of HER2/neu Peptide GLSI-100 (GP2 + GM-CSF) in HER2/neu Positive Subjects with Residual Disease or High-Risk PCR after both Neoadjuvant and Postoperative Adjuvant Trastuzumab-based Therapy (FLAMINGO-01)

This phase II trial compares the effect of adding ipatasertib to pembrolizumab (standard immunotherapy) vs. pembrolizumab alone in treating patients with squamous cell cancer of the head and neck that has come back (recurrent) or that has spread from where it first started (primary site) to other places in the body (metastatic). Ipatasertib is in a class of medications called protein kinase B (AKT) inhibitors. It may stop the growth of tumor cells and may kill them. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving ipatasertib in combination with pembrolizumab may be more effective than pembrolizumab alone in improving some outcomes in patients with recurrent/metastatic squamous cell cancer of the head and neck.

Note: This is only a partial description of the study. Please contact the Robert H. Lurie Comprehensive Cancer Center of Northwestern University if you are interested in the trial.

A Phase 1/2 study to assess the safety and tolerability and how prostate cancer responds to two different doses of investigational study drug ARV-766 given by mouth in men with metastatic castration-resistant prostate cancer who have progressed on prior approved systemic therapies

This is a first-in-human, Phase I, open-label, multicenter study designed to evaluate the safety, tolerability and preliminary efficacy of WTX-124, a conditionally activated IL-2 prodrug, when administered as monotherapy and in combination with pembrolizumab, for the treatment of patients with advanced solid tumors. Part 1 of the study is dose escalation of WTX-124, both as monotherapy and in combination with pembrolizumab. Part 2 is comprised of four arms in which WTX-124 will be administered as monotherapy and in combination with pembrolizumab to patients with advanced or metastatic cutaneous malignant melanoma or advanced or metastatic renal cell carcinoma.

Note: This is only a partial description of the study. Please contact the Robert H. Lurie Comprehensive Cancer Center of Northwestern University if you are interested in the trial.

Multicenter, open-label, dose-escalation, safety, tolerability, PK and pharmacodynamic study with a dose expansion at the RP2D to evaluate safety and potential antitumor activity of Q901

Note: This is only a partial description of the study. Please contact the Robert H. Lurie Comprehensive Cancer Center of Northwestern University if you are interested in the trial.

The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics of intravenous (IV) administration of XmAb808 in combination with pembrolizumab in subjects with selected advanced solid tumors and to identify the minimum safe and biologically effective/recommended dose (RD) and schedule for XmAb808.

Note: This is only a partial description of the study. Please contact the Robert H. Lurie Comprehensive Cancer Center of Northwestern University if you are interested in the trial.

As the number of available treatments for CTCL grow, there is a need to find a way to identify which treatment will work best for each subject. The goal of this study is to develop a test called a gene expression assay to see if the assay can predict treatment success and/or failure in subjects with CTCL.

Compassionate use access to belantamab mafodotin (GSK2857916) for eligible participants with refractory/relapsing multiple myeloma