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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

Study 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 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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My cancer has PD-L1 amplification, confirmed by a study chair.
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I was in the NCI-MATCH trial but didn't match any treatments or have finished all recommended treatments.
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My cancer's origin is unknown.
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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 meet specific health and treatment criteria for a new cancer trial.
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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 am HIV-positive with a specific CD4+ cell count and no AIDS-defining illnesses.
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I do not have any serious ongoing health issues that are not under control.
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I have recovered from major surgery effects for at least 14 days.
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My pregnancy-related cancer is confirmed by a specific blood test within the last 28 days.
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I haven't needed treatment for an autoimmune disease in the last 2 years.

Timeline

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

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 more

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
Magnetic Resonance Imaging
2017
Completed Phase 3
~1190
Computed Tomography
2017
Completed Phase 2
~2720
Nivolumab
2014
Completed Phase 3
~4750
Echocardiography
2013
Completed Phase 4
~11670
Biospecimen Collection
2004
Completed Phase 2
~1730
Ipilimumab
2014
Completed Phase 3
~2670

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor
13,654 Previous Clinical Trials
40,932,335 Total Patients Enrolled
1 Trials studying PEComas
140 Patients Enrolled for PEComas
Sandip P PatelPrincipal InvestigatorSWOG Cancer Research Network

Media Library

Ipilimumab (Checkpoint Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT02834013 — Phase 2
PEComas Clinical Trial 2023: Ipilimumab Highlights & Side Effects. Trial Name: NCT02834013 — Phase 2
Ipilimumab (Checkpoint Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02834013 — Phase 2
PEComas Research Study Groups: Arm II (nivolumab), Arm I (nivolumab, ipilimumab)
PEComas Patient Testimony for trial: Trial Name: NCT02834013 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

For what medical conditions is Ipilimumab commonly given?

"Ipilimumab can be used to treat conditions such as previous anti-angiogenic therapy, malignant neoplasms, and unresectable melanoma."

Answered by AI

Are there any metropolitan hospitals participating in this research project?

"Currently, this trial is being run at 100 different sites. They are situated in locations such as Fremont, Los Angeles and Ontario as well as 100 other places. It would be advantageous to choose the location nearest you to cut down on travel if you decide to participate."

Answered by AI

Are there other medical studies that have used Ipilimumab as a treatment?

"Ipilimumab was first trialled in 2009 Texas Children's Hospital. Subsequently, there have been a total of 369 completed trials with 796 currently active trials; many of which are based out of Fremont, California."

Answered by AI

What is the FDA's opinion of Ipilimumab?

"While there is some evidence to support the safety of Ipilimumab, it only received a score of 2 because this treatment is still in Phase 2 clinical trials."

Answered by AI

Is there still room for more participants in this experiment?

"That is correct. The listing on clinicaltrials.gov indicates that this trial, which was first posted on January 13th 2017, has currently open recruitment and is looking for 818 patients at 100 different sites."

Answered by AI

Who else is applying?

What site did they apply to?
University of South Alabama Mitchell Cancer Institute
Cancer Center of Kansas-Kingman
Tidelands Georgetown Memorial Hospital
What portion of applicants met pre-screening criteria?
Did not meet criteria
How many prior treatments have patients received?
1

What questions have other patients asked about this trial?

Do I have to pay for the treatment? How long will my treatment process take?
PatientReceived 2+ prior treatments

Why did patients apply to this trial?

I hope thus clinical trial help me.
PatientReceived no prior treatments
Recent research and studies
~177 spots leftby May 2026