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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)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 4 years
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 belowSelect...
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.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 4 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 4 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Objective response rate (ORR) by BICR
Progression free survival (PFS) by blinded independent central review (BICR)
Secondary outcome measures
Disease control rate (DCR) by BICR
Disease control rate (DCR) by investigator
Duration of response (DoR) by BICR
+21 moreTrial 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
2014
Completed Phase 3
~2610
Nivolumab
2014
Completed Phase 3
~4750
Find a Location
Who is running the clinical trial?
Bristol-Myers SquibbLead Sponsor
2,650 Previous Clinical Trials
4,130,395 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I do not have active brain metastases.I have been treated with specific immune system targeting drugs.I have not had any drug treatments for kidney cancer.I have an autoimmune disease.My kidney cancer cannot be cured with surgery or radiation.My cancer can be measured on scans according to specific criteria.My kidney cancer has been confirmed to have clear cell features, possibly with sarcomatoid traits.My kidney cancer is classified as intermediate or poor risk.
Research Study Groups:
This trial has the following groups:- Group 1: Nivolumab + ipilimumab
- Group 2: Nivolumab + ipilimumab placebo
Awards:
This trial has 1 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
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.
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