No Placebo-Only Group

Pivotal Trial

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

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.

Ipilimumab

Nivolumab

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

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

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

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.

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

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

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

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 trial is testing tarlatamab, a special medicine, in people with Small Cell Lung Cancer. Tarlatamab helps the immune system find and destroy cancer cells.

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.

I can take care of myself and am up and about more than half of my waking hours.

I have had treatment for brain metastases and meet specific criteria.

I have had an organ transplant or autoimmune disease treated in the last 2 years.

I had severe side effects from immune therapy that stopped my treatment.

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

I have untreated or worsening brain cancer spread, including in the protective layers of the brain.

AMG 757

This study will investigate if nivolumab will improve recurrence-free survival (RFS) compared to placebo in participants with HCC who have undergone complete resection or have achieved a complete response after local ablation, and who are at high risk of recurrence

A Study of Nivolumab in Participants With Hepatocellular Carcinoma Who Are at High Risk of Recurrence After Curative Hepatic Resection or Ablation

Nivolumab for Liver Cancer

I have had treatments for liver cancer before.

I had surgery or ablation for liver cancer as my first treatment.

My liver cancer is not caused by a virus, or it's due to hepatitis B or C.

I have not received a live vaccine in the last 30 days.

My cancer has spread or I have more than one type of cancer.

My liver cancer is of a specific type (fibrolamellar, sarcomatoid, or mixed).

I have had a liver transplant or am waiting for one.

There are additional rules that determine who can participate in the study based on specific requirements set by the study protocol.

Placebo

Evaluate the safety and tolerability of sotorasib in adult subjects with KRAS p.G12C mutant advanced solid tumors.

Estimate the maximum tolerated dose (MTD) and/or a recommended phase 2 dose (RP2D) in adult subjects with KRAS p.G12C mutant advanced solid tumors.

A Phase 1/2, Study Evaluating the Safety, Tolerability, PK, and Efficacy of Sotorasib (AMG 510) in Subjects With Solid Tumors With a Specific KRAS Mutation (CodeBreaK 100)

Sotorasib for Solid Tumors

I have brain metastases not originating from a brain tumor.

My cancer is advanced or has spread, and tests show a KRAS p.G12C mutation.

I cannot take pills due to my GI condition.

I have not had a heart attack in the last 6 months.

Sotorasib (AMG 510)

GSK-3β is a potentially important therapeutic target in human malignancies. The Actuate 1801 Phase 1/2 study is designed to evaluate the safety and efficacy of 9-ING-41, a potent GSK-3β inhibitor, as a single agent and in combination with cytotoxic agents, in patients with refractory cancers.

9-ING-41 in Patients with Advanced Cancers

9-ING-41 for Advanced Cancers

My cancer is advanced, and current treatments aren’t working or suitable for me.

I do not have severe heart problems or recent strokes.

I have not taken any experimental cancer drugs recently nor am I in another clinical trial.

Your lab test results are within the normal range.

I have fast-growing brain tumors or cancer in the lining of my brain.

I have another active cancer besides the one being targeted.

I can take care of myself and perform daily activities.

I have completed my last dose of certain treatments as required before starting the study drug.

I am a man and will use birth control or abstain from sex to prevent pregnancy during and 90 days after the study.

You have tumors that can be measured and assessed using standard imaging or lab tests.

I have recovered from side effects of cancer treatment, except for hair loss or infertility.

I have had major surgery recently or will have one during the study.

9-ING-41

To assess the safety and efficacy of intensity-modulated proton therapy (IMPT) for small cell lung cancer (SCLC)

Prospective Study of Intensity-Modulated Proton Therapy (IMPT) for Small Cell Lung Cancer

Proton Therapy for Small Cell Lung Cancer

I am recommended to undergo a specific type of chest radiation therapy.

My lung cancer is confirmed to be small cell type.

I've had radiation therapy that overlaps with the area planned for my current treatment.

Principal Investigator, Associate Professor, Department of Radiation Oncology

Intensity-Modulated Proton Therapy (IMPT)

This study is open to adults with small cell lung cancer and other neuroendocrine cancers that are positive for the tumour marker delta-like 3 (DLL3). The study is in people with advanced cancer for whom previous treatment was not successful or no standard treatment exists.

The purpose of this study is to find out the highest dose of BI 764532 and the best treatment schedule that people can tolerate. BI 764532 is an antibody-like molecule (DLL3/CD3 bispecific) that may help the immune system fight cancer. In this study, BI 764532 is given to people for the first time. That means no clinical data are available for BI 764532.

Participants get BI 764532 either weekly or once every 3 weeks. If there is benefit for the participants and if they can tolerate it, the treatment is given for a maximum of 3 years. During this time, participants visit the study site about 20 times depending on the response to the treatment. Doctors record any unwanted effects and regularly check the general health of the participants.

A Study to Test Different Doses of BI 764532 in Patients With Small Cell Lung Cancer and Other Neuroendocrine Tumours That Are Positive for DLL3

BI 764532 for Small Cell Lung Cancer

My cancer is advanced or has spread and cannot be cured with surgery or radiation.

I cannot use or have not responded to standard treatments.

I can't use standard cancer treatments or they didn't work for me.

My cancer is a type of neuroendocrine or small cell carcinoma.

The patient has agreed to provide a pre-treatment and on-treatment fresh tumor biopsy as part of a mandatory back-fill cohort.

I have a measurable cancer lesion outside of my brain.

I have previously received treatments targeting DLL3.

I am not pregnant, nursing, or planning to become pregnant within 3 months after the trial ends.

I do not have an active infection needing treatment or recent COVID-19.

My tumor is mostly made up of neuroendocrine or small cells, at least 50%.

I have an immune system disorder or have been on steroids or other immune-weakening medicines in the last week.

I do not have another cancer that could affect my treatment.

I am on blood thinners that cannot be safely stopped.

My tumor is mostly made up of neuroendocrine/small tumor cells.

I have lasting side effects from past treatments that are mild or better.

I have at least one measurable cancer lesion outside of my brain.

My liver, kidneys, and bone marrow are working well.

I have brain metastases but meet certain conditions.

Winship Cancer Institute Clinical Trials 2022

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