No Placebo-Only Group

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. IM-862 may kill tumor cells by stopping blood flow to the tumor and by stimulating a person's white blood cells to kill tumor cells. Combining chemotherapy and IM-862 may kill more tumor cells.

PURPOSE: Randomized phase II trial to study the effectiveness of combination chemotherapy and IM-862 in treating patients who have resected stage III ovarian cancer or primary peritoneal cancer.

Combination Chemotherapy Plus IM-862 in Treating Patients With Resected Stage III Ovarian Cancer or Primary Peritoneal Cancer

Combination Chemotherapy + IM-862 for Ovarian Cancer

This study is evaluating whether a combination of chemotherapy and IM-862 might be more effective than chemotherapy alone in treating patients who have resected stage III ovarian cancer or primary peritoneal cancer.

I am not currently undergoing gene therapy.

I am not currently receiving IL-2 treatment.

I have not had chemotherapy for my current cancer.

I am not currently taking any drugs that stop the formation of new blood vessels.

I have not had radiation for my current cancer.

I have stage III ovarian or primary peritoneal cancer.

I had surgery to reduce my tumor size within the last 6 weeks.

My surgery removed the cancer well, leaving no large remaining tumors.

All my cancer outside the reproductive tract has been removed.

My liver function tests are within normal ranges.

My kidney function tests are within normal ranges.

I haven't had any other cancer in the last 5 years.

I don't have any serious illnesses that would shorten my life.

I am in good overall health with no major medical or social issues affecting study participation.

I can take care of myself but might not be able to do heavy physical work.

I have had surgery to remove my uterus, ovaries, and fallopian tubes.

I have not received IL-2 treatment recently.

I have not received hormone therapy for my current cancer.

I am not receiving any other chemotherapy treatments.

I haven't had biologic therapy for my current cancer.

Combination Chemotherapy

IM-862

Pivotal Trial

The purpose of this study is to show that Nivolumab and/or Nivolumab in combination with Ipilimumab will extend progression free survival and overall survival compared to Ipilimumab alone.

Phase 3 Study of Nivolumab or Nivolumab Plus Ipilimumab Versus Ipilimumab Alone in Previously Untreated Advanced Melanoma (CheckMate 067)

Nivolumab +/− Ipilimumab for Melanoma

I have active cancer spread to my brain or its coverings.

I haven't taken high-dose steroids or other immune-weakening drugs in the last 2 weeks.

My melanoma is at an advanced stage and cannot be surgically removed.

I have been treated with specific immune therapy drugs before.

I have not received any treatment for my condition.

I can provide a tissue sample from my cancer that cannot be surgically removed or has spread.

I am fully active or restricted in physically strenuous activity but can do light work.

You have a known autoimmune disease that is currently active or suspected.

Ipilimumab

Nivolumab

To investigate the safety and efficacy of nivolumab as a single agent or in combination with ipilimumab in 6 tumor types - triple-negative breast cancer (TNBC), gastric cancer (GC), pancreatic adenocarcinoma (PC), small cell lung cancer (SCLC), bladder cancer (BC), and ovarian cancer (OC). A combination of nivolumab with ipilimumab and cobimetinib is also investigated in PC.

A Study of Nivolumab by Itself or Nivolumab Combined With Ipilimumab in Patients With Advanced or Metastatic Solid Tumors

Nivolumab + Ipilimumab for Solid Tumors

This study is evaluating whether nivolumab is safe and effective in treating cancer.

I have not received treatments like anti-PD-1 or Ipilimumab.

My cancer is one of the specified types and is advanced or has spread.

My blood and organ tests are within normal ranges.

I can perform all my usual activities without assistance.

Cobimetinib

The purpose of this study is to compare the objective response rate, progression free survival and the overall survival of Nivolumab combined with Ipilimumab to Sunitinib monotherapy in patients with previously untreated Renal Cell Cancer.

Nivolumab Combined With Ipilimumab Versus Sunitinib in Previously Untreated Advanced or Metastatic Renal Cell Carcinoma (CheckMate 214)

Nivolumab + Ipilimumab for Kidney Cancer

This study is evaluating whether a combination of two drugs is better than one drug alone.

I am able to care for myself but may not be able to do active work.

My kidney cancer cannot be cured with surgery or radiation.

My kidney cancer diagnosis includes clear-cell features.

I have previously been treated with specific immunotherapy drugs.

I have kidney cancer and haven't had systemic therapy, except possibly one treatment that didn't target VEGF if my cancer returned 6+ months after.

You have a measurable tumor according to specific guidelines.

I have had or currently have cancer spread to my brain.

I don't have an active autoimmune disease or need strong immune system medications.

I have previously been treated with drugs targeting blood vessel growth in cancer.

I haven't taken high-dose steroids or immunosuppressants in the last 14 days.

My tumor sample is ready and suitable for the study's requirements.

Sunitinib

This open-label, multicenter, randomized Phase III study is designed to compare the efficacy and safety of a combined regimen of obinutuzumab and venetoclax versus obinutuzumab + chlorambucil in participants with chronic lymphocytic leukemia (CLL) and coexisting medical conditions. The time on study treatment was approximately one year and the follow-up period will be up to 9 years.

Comparison of the Treatments of Obinutuzumab + Venetoclax Versus Obinutuzumab + Chlorambucil in Patients With Chronic Lymphocytic Leukemia

Obinutuzumab + Venetoclax vs. Chlorambucil for Chronic Lymphocytic Leukemia

This study is evaluating whether a combination of obinutuzumab and venetoclax is more effective than obinutuzumab + chlorambucil in people with chronic lymphocytic leukemia.

I haven't had a serious infection needing treatment in the last 2 months.

I have chronic lymphocytic leukemia that has not been treated before.

I have an uncontrolled immune system disorder affecting my red blood cells or platelets.

I had cancer before but have recovered from the treatment side effects.

My blood cell counts are good without needing extra help, unless it's because of my CLL.

I need to take blood thinners like warfarin.

I haven't used any experimental drugs or cancer treatments in the last 4 weeks.

I haven't taken strong or moderate CYP3A inhibitors or inducers in the last week.

I am currently pregnant or breastfeeding.

My CLL has transformed into a more aggressive form of lymphoma.

My health issues won't stop me from getting the trial's treatment, except for problems with my eyes, ears, nose, or throat.

My cancer has spread to my brain or spinal cord.

I have been diagnosed with progressive multifocal leukoencephalopathy.

Chlorambucil

Obinutuzumab

Venetoclax

The purpose of this study is to determine whether nivolumab is better than ipilimumab to prevent recurrence of melanoma.

Efficacy Study of Nivolumab Compared to Ipilimumab in Prevention of Recurrence of Melanoma After Complete Resection of Stage IIIb/c or Stage IV Melanoma

Nivolumab vs Ipilimumab for Preventing Melanoma Recurrence

This study is evaluating whether a new drug called nivolumab is better than a drug called ipilimumab to prevent recurrence of melanoma.

I am at least 15 years old, or 18 where required by local laws.

My cancer was stage IIIb/C or IV before it was fully removed.

I have had cancer spread to the lining of my brain and spinal cord.

I have not received any anti-cancer treatments before.

You have had an autoimmune disease in the past.

My melanoma was fully removed by surgery within the last 12 weeks.

I received treatment for melanoma after surgery.

This is an open-label, multicenter, global Phase 2 basket study of entrectinib (RXDX-101) for the treatment of patients with solid tumors that harbor an NTRK1/2/3, ROS1, or ALK gene fusion. Patients will be assigned to different baskets according to tumor type and gene fusion.

Basket Study of Entrectinib (RXDX-101) for the Treatment of Patients With Solid Tumors Harboring NTRK 1/2/3 (Trk A/B/C), ROS1, or ALK Gene Rearrangements (Fusions)

Entrectinib for Solid Tumors

This study is evaluating whether a drug may help treat tumors with certain gene fusions.

I have been treated with specific inhibitors for my cancer due to certain gene changes.

My cancer can be measured or seen on tests.

I finished my radiotherapy more than 14 days ago.

My cancer is advanced and tests positive for specific genetic changes.

I have a family or personal history of bone disorders.

I am still recovering from a recent surgery.

I have had heart failure symptoms or a low heart pump function in the last 3 months.

I have a history of long QT intervals not caused by medication.

I have risk factors for irregular heartbeats.

My brain involvement from cancer is either symptom-free or was treated and is now under control.

I have lung scarring or inflammation from previous treatments.

I have moderate to severe numbness, tingling, or pain in my hands or feet.

I have a condition that affects my stomach or intestines' ability to absorb nutrients.

I can provide a tissue sample for testing unless it's medically unsafe for me.

I have had cancer treatment but not with Trk, ROS1, or ALK inhibitors for specific gene changes.

It's been over 2 weeks since my last cancer treatment.

It has been over 4 weeks since my last antibody therapy.

I can care for myself and doctors expect me to live at least another month.

I have no other cancers that would affect this trial's results.

Entrectinib

This study is about a medicine called TAK-788, also known as mobocertinib, given to adults with non-small cell lung cancer. The main aims of this study are to check if there are any side effects from TAK-788, to learn how TAK-788 is processed by the body, and to determine the best dose of TAK-788 to treat this condition. Participants will take TAK-788 capsules with chemotherapy. Participants will continue to take TAK-788 unless they or their doctor decide they should stop this treatment. Participants will take TAK-788 capsules with or without chemotherapy under antidiarrhea prevention to determine the safety of TAK-788 treatment. Non-Asian, non-White participants will take TAK-788 to determine the safety and tolerability of TAK-788 treatment.

A Study of TAK-788 in Adults With Non-Small Cell Lung Cancer

TAK-788 for Non-Small Cell Lung Cancer

I have no other cancers except for certain skin, cervical, or treated prostate cancers.

I haven't taken strong or moderate CYP3A affecting drugs in the last 10 days.

I am willing and able to follow the study's schedule and procedures.

My condition hasn't improved with standard treatments.

Your heart's electrical activity is normal on the screening test.

My cancer has a specific EGFR gene change and there's enough tissue for more tests.

I've had 1 or 2 treatments for my advanced cancer.

I have previously been treated with TAK-788.

My cancer has a specific EGFR mutation, but not the exon 20 insertion.

My NSCLC with EGFR exon 20 mutation responded to treatment but has worsened without spreading to my brain.

I haven't taken any cancer drugs except for EGFR inhibitors within the last 14 days.

I have brain metastases needing steroids for symptom control recently.

I do not have active brain tumors, uncontrolled heart issues, severe infections, lung conditions, or am not pregnant or breastfeeding.

My cancer has a specific HER2 gene change.

I have new or worsening brain metastases that haven't been treated before.

My lung cancer has a specific genetic change and hasn't been treated yet for its advanced stage.

I had radiotherapy less than 14 days ago or still have side effects.

My cancer has a specific EGFR gene change.

I have enough tumor tissue available for testing.

I have not had major surgery in the last 4 weeks.

You have a disease that can be measured using specific guidelines for evaluating tumors.

My cancer, not lung, has specific mutations and no brain metastases.

I haven't taken cancer immunotherapy or similar treatments in the last 28 days.

My cancer is advanced or has spread and is confirmed by lab tests.

You are expected to live for at least 3 months.

TAK-788

This study looked at how effective the study drug (tepotinib) was at stopping the growth and spread of lung cancer. This study also measures a number of other things including safety of the study drug and the side effects, how body processes the study drug, or how the study drug affects your quality of life. The study also has an optional pharmacogenetic research part. Pharmacogenetic research is an important way to try to understand the role of genetics in human disease and how genes impact the effectiveness of drugs, because differences in genes can change the way a person responds to a particular drug.

Tepotinib Phase II in NSCLC Harboring MET Alterations (VISION)

Tepotinib for Lung Cancer

This study is evaluating whether a drug may help treat lung cancer.

I agree to use, and ensure my partner uses, effective birth control.

My lung cancer is advanced and has been confirmed by lab tests.

I am not pregnant or breastfeeding and either cannot become pregnant or agree to use effective birth control.

You have a current drug or alcohol problem, ongoing infection, or other serious health or mental issues that could make it risky for you to take part in the trial, as decided by the doctors in charge.

I am legally unable to make my own decisions.

My cancer has EGFR mutations sensitive to targeted therapy.

I do not have HIV, hepatitis B, or hepatitis C.

My cancer's size can be measured and has been confirmed by a review committee.

My cancer has a specific genetic change called METex14.

I have a condition that affects my ability to swallow or absorb medications.

I needed a blood transfusion within the last 14 days.

My only measurable cancer is in my brain.

I have been treated with drugs targeting the HGF/c-Met pathway before.

My high blood pressure is not controlled below 150/90 mmHg despite treatment.

I have only had NSCLC or skin/cervical cancer that was fully treated over 5 years ago with no signs of return.

I haven't had cancer treatment except for palliative radiotherapy in the last 21 days.

My blood, liver, kidney, or heart function is not normal.

I have had no more than 2 previous treatments for my condition.

My cancer is sensitive to ALK-targeted therapy due to specific genetic changes.

I have not had major surgery in the last 28 days.

I am fully active or can carry out light work.

I don't have any lasting side effects from cancer treatment worse than Grade 1.

I have brain metastases causing symptoms and affecting my neurological stability.

Tepotinib

The main purpose of this study is to compare how long subjects with esophageal cancer live overall or live without disease progression after receiving nivolumab and ipilimumab or nivolumab combined with fluorouracil plus cisplatin versus fluorouracil plus cisplatin

A Study to Evaluate Efficacy in Subjects With Esophageal Cancer Treated With Nivolumab and Ipilimumab or Nivolumab Combined With Fluorouracil Plus Cisplatin Versus Fluorouracil Plus Cisplatin

Immunotherapy + Chemotherapy for Esophageal Cancer

This study is evaluating whether a combination of two drugs can improve survival for people with esophageal cancer.

I have tested positive for hepatitis B or C.

I can walk and do light activities like housework or office work.

I have cancer in my brain or spinal cord that shows symptoms or needs treatment.

My cancer is a type of esophageal cancer called squamous cell or adenosquamous carcinoma.

My esophageal cancer is advanced, cannot be surgically removed, or treated with the intent to cure.

I do not have any serious or uncontrolled health issues or active infections.

I agree to provide a sample of my tumor tissue for the study.

Cisplatin

Fluorouracil

A study to assess the safety, tolerability, and PK of tarlatamab in participants with SCLC

Study Evaluating Safety, Tolerability and Pharmacokinetics (PK) of Tarlatamab in Adults With Small Cell Lung Cancer (SCLC)

Tarlatamab for Small Cell Lung Cancer

This study is evaluating whether a drug may help treat small cell lung cancer.

I have a lung condition not caused by an infection.

I have not taken steroids or immunosuppressants in the last 7 days.

I have not had any other cancer besides my current one in the last 2 years.

It's been over 28 days since my last cancer treatment, or 14 days if it was chemotherapy and I've recovered from side effects.

I haven't had signs of a serious infection in the last week.

My small cell lung cancer has returned or worsened after platinum-based treatment.

Winship Cancer Institute Clinical Trials 2022

Trials at this site

Combination Chemotherapy + IM-862 for Ovarian Cancer

Nivolumab +/− Ipilimumab for Melanoma

Obinutuzumab + Venetoclax vs. Chlorambucil for Chronic Lymphocytic Leukemia

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