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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
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.Check my eligibility
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.See study design
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 belowSelect...
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
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Overall response rate (ORR)
Secondary outcome measures
Best response
Clinical benefit rate
Incidence of adverse events
+2 moreTrial 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
Magnetic Resonance Imaging
2017
Completed Phase 3
~1160
Echocardiography
2013
Completed Phase 4
~11670
Nivolumab
2014
Completed Phase 3
~4740
Computed Tomography
2017
Completed Phase 2
~2720
Biospecimen Collection
2004
Completed Phase 2
~1720
Ipilimumab
2014
Completed Phase 3
~2610
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)Lead Sponsor
13,748 Previous Clinical Trials
40,958,583 Total Patients Enrolled
Sandip P PatelPrincipal InvestigatorSWOG Cancer Research Network
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have been cancer-free from another type for at least one year.I have a rare cancer type and can provide samples, except if I have GTD.My cancer has PD-L1 amplification, confirmed by a study chair.I was in the NCI-MATCH trial but didn't match any treatments or have finished all recommended treatments.My cancer has worsened after treatment and no other standard treatments are suitable or available for me.My cancer's origin is unknown.I've had a CT scan or MRI within the last 28 days showing measurable disease.My condition worsened after treatment, or no effective treatment exists for me.I meet specific health and treatment criteria for a new cancer trial.I agree to use birth control during and after the study for the time required.I do not have an active hepatitis B or C infection.I am HIV-positive with a specific CD4+ cell count and no AIDS-defining illnesses.I do not have any serious ongoing health issues that are not under control.I have recovered from major surgery effects for at least 14 days.My pregnancy-related cancer is confirmed by a specific blood test within the last 28 days.Criterion: For most groups, patients must have a rare cancer confirmed by tests. For the gestational trophoblastic disease group, patients must have the disease confirmed by a specific blood test. Patients with specific gene changes may be included in the study without needing to participate in another test.I have stage I or II thyroid or prostate cancer that is under control.I haven't needed treatment for an autoimmune disease in the last 2 years.
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Research Study Groups:
This trial has the following groups:- Group 1: Arm II (nivolumab)
- Group 2: Arm I (nivolumab, ipilimumab)
Pancreatic Neuroendocrine Tumors Patient Testimony for trial: Trial Name: NCT02834013 — Phase 2
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