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Checkpoint Inhibitor

Nivolumab + Ipilimumab for Rare Cancers

Phase 2

Waitlist Available

Led By Sandip P Patel

Research Sponsored by National Cancer Institute (NCI)

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Any other cancer from which the patient has been disease free for one year

Patients must have histologically and/or biochemically confirmed rare cancer and be able to submit specimens, except for the gestational trophoblastic disease (GTD) cohort

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 10 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is studying nivolumab and ipilimumab in treating patients with rare tumors.

Who is the study for?

This trial is for patients with rare cancers, including various carcinomas and tumors. Eligible participants must have progressed after standard therapy or have no survival-prolonging treatment available. They should not have uncontrolled illnesses or active infections like HBV/HCV, and must agree to use birth control if of reproductive potential. A negative pregnancy test is required for women of childbearing age.

What is being tested?

The study tests nivolumab and ipilimumab, two immunotherapy drugs that may help the immune system fight cancer by stopping tumor cells from growing. It's a phase II trial where patients are grouped based on their specific type of rare tumor to see how well these treatments work.

What are the potential side effects?

Potential side effects include immune-related reactions such as inflammation in organs, skin rash, hormone gland problems (like thyroid dysfunction), digestive issues (colitis), liver inflammation (hepatitis), lung issues (pneumonitis), infusion reactions, fatigue, and flu-like symptoms.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have been cancer-free from another type for at least one year.

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I have a rare cancer type and can provide samples, except if I have GTD.

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I've had a CT scan or MRI within the last 28 days showing measurable disease.

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My condition worsened after treatment, or no effective treatment exists for me.

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I agree to use birth control during and after the study for the time required.

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I do not have an active hepatitis B or C infection.

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I do not have any serious ongoing health issues that are not under control.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 10 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 10 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 10 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Overall response rate (ORR)

Secondary study objectives

Best response

Clinical benefit rate

Incidence of adverse events

+2 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Arm II (nivolumab)Experimental Treatment5 Interventions

Patients receive nivolumab IV over 30 minutes on days 1, 15 and 29. Treatment repeats every 42 days for up to 17 cycles (2 years) in the absence of disease progression or unacceptable toxicity. After 17 cycles (2 years) of therapy, patients may receive nivolumab once every 14 or 28 days (2 weeks or 4 weeks) in the absence of disease progression or unacceptable toxicity. Patients undergo ECHO during screening and on study. Patients also undergo MRI or CT throughout the trial. Additionally, patients undergo blood sample collection throughout the trial.

Group II: Arm I (nivolumab, ipilimumab)Experimental Treatment6 Interventions

Patients receive nivolumab IV over 30 minutes on days 1, 15, and 29 and ipilimumab IV over 60 minutes on day 1. Treatment repeats every 42 days for up to 17 cycles (2 years) in the absence of disease progression or unacceptable toxicity. Patients who complete 17 cycles (2 years) of therapy, may continue receiving the same treatment with nivolumab and ipilimumab, or receive nivolumab once every 14 or 28 days (2 weeks or 4 weeks) per physician discretion in the absence of disease progression or unacceptable toxicity. Patients who stop treatment prior to the completion of 17 cycles of therapy may receive nivolumab once every 14 or 28 days (2 weeks or 4 weeks) in the absence of disease progression or unacceptable toxicity. Patients undergo ECHO during screening and on study. Patients also undergo MRI or CT throughout the trial. Additionally, patients undergo blood sample collection throughout the trial.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Echocardiography

2013

Completed Phase 4

~11580

Computed Tomography

2017

Completed Phase 2

~2790