Nivolumab + Ipilimumab for Kidney Cancer

Recruiting in Palo Alto (17 mi)

+159 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: Bristol-Myers Squibb

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?

The purpose of this study is to test the effectiveness and safety of nivolumab combined with ipilimumab compared to nivolumab monotherapy in participants with previously untreated kidney cancer that has spread.

Research Team

Bristol-Myers Squibb

Principal Investigator

Bristol-Myers Squibb

Eligibility Criteria

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.

Inclusion Criteria

I have not had any drug treatments for kidney cancer.

My kidney cancer cannot be cured with surgery or radiation.

My cancer can be measured on scans according to specific criteria.

Exclusion Criteria

I do not have active brain metastases.

I have been treated with specific immune system targeting drugs.

I have an autoimmune disease.

Treatment Details

Interventions

• Ipilimumab (Checkpoint Inhibitor)
• Nivolumab (Checkpoint Inhibitor)

Trial Overview 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.

Participant Groups

Group I: Nivolumab + ipilimumab placebo Experimental Treatment 1 Intervention

Group II: Nivolumab + ipilimumab Experimental Treatment 2 Interventions

Who Is Running the Clinical Trial?

Bristol-Myers Squibb

Lead Sponsor

Trials

2,731

Recruited

4,127,000+

Headquarters

New York City, USA

Known For

Oncology & Cardiovascular

Top Products

Eliquis, Opdivo, Revlimid, Orencia

Christopher Boerner

Bristol-Myers Squibb

Chief Executive Officer since 2023

PhD in Business Administration from the Haas School of Business, University of California, Berkeley; BA in Economics and History from Washington University in St. Louis

Deepak L. Bhatt

Bristol-Myers Squibb

Chief Medical Officer since 2024

MD from Yale University; MSc in Clinical Epidemiology from the University of Pennsylvania