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Checkpoint Inhibitor

Nivolumab + Ipilimumab for Kidney Cancer

Phase 3
Waitlist Available
Research Sponsored by Bristol-Myers Squibb
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
No prior systemic therapy for RCC
Advanced (not amenable to curative surgery or radiation therapy) renal cell carcinoma (RCC) or metastatic RCC (mRCC)
Must not have
Any active central nervous system (CNS) metastases
Prior treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, anti-CTLA-4 antibody, or any other agents specifically targeting T-cell co-stimulation or checkpoint pathways
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
Pivotal Trial

Summary

This trial will test a new combination therapy for kidney cancer that has spread. The goal is to see if it is more effective and safe than a monotherapy treatment.

Who is the study for?
This trial is for adults with advanced kidney cancer that can't be removed by surgery or treated with radiation. They should not have had any previous systemic treatments for their cancer, must show measurable signs of the disease on scans, and be classified as having an intermediate or poor prognosis.
What is being tested?
The study is comparing the effectiveness of two approaches: one group will receive Nivolumab combined with Ipilimumab (both are immunotherapy drugs), while another group gets Nivolumab alone. The goal is to see which treatment works better for new kidney cancer patients.
What are the potential side effects?
Nivolumab and Ipilimumab may cause immune-related side effects such as inflammation in various organs, skin rash, hormone gland problems like thyroiditis, digestive issues like colitis, liver inflammation called hepatitis, and potential lung issues known as pneumonitis.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have not had any drug treatments for kidney cancer.
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My kidney cancer cannot be cured with surgery or radiation.
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My cancer can be measured on scans according to specific criteria.
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My kidney cancer is classified as intermediate or poor risk.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I do not have active brain metastases.
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I have been treated with specific immune system targeting drugs.
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I have an autoimmune disease.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups
Experimental Treatment
Group I: Nivolumab + ipilimumab placeboExperimental Treatment1 Intervention
Group II: Nivolumab + ipilimumabExperimental Treatment2 Interventions
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ipilimumab
2015
Completed Phase 3
~3420
Nivolumab
2015
Completed Phase 3
~4010

Find a Location

Who is running the clinical trial?

Bristol-Myers SquibbLead Sponsor
2,696 Previous Clinical Trials
4,098,634 Total Patients Enrolled

Media Library

Ipilimumab (Checkpoint Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT03873402 — Phase 3
Kidney Cancer Research Study Groups: Nivolumab + ipilimumab, Nivolumab + ipilimumab placebo
Kidney Cancer Clinical Trial 2023: Ipilimumab Highlights & Side Effects. Trial Name: NCT03873402 — Phase 3
Ipilimumab (Checkpoint Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03873402 — Phase 3
~67 spots leftby Dec 2025
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