Nivolumab + Ipilimumab for Kidney Cancer

Recruiting in Palo Alto (17 mi)

+383 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 compare the objective response rate, progression free survival and the overall survival of Nivolumab combined with Ipilimumab to Sunitinib monotherapy in patients with previously untreated Renal Cell Cancer.

Research Team

Bristol-Myers Squibb

Principal Investigator

Bristol-Myers Squibb

Eligibility Criteria

This trial is for adults with advanced or metastatic renal cell carcinoma who haven't had systemic therapy for it, except possibly one adjuvant/neoadjuvant therapy not targeting VEGF if recurrence was over 6 months ago. Participants must have a KPS of at least 70%, measurable disease, and provide tumor tissue samples. Exclusions include brain metastases, prior VEGF/VEGF receptor targeted therapies or immunotherapies, current CNS metastases, and certain autoimmune diseases.

Inclusion Criteria

I am able to care for myself but may not be able to do active work.

My kidney cancer cannot be cured with surgery or radiation.

My kidney cancer diagnosis includes clear-cell features.

Exclusion Criteria

I have previously been treated with specific immunotherapy drugs.

I have had or currently have cancer spread to my brain.

I don't have an active autoimmune disease or need strong immune system medications.

Treatment Details

Interventions

• Ipilimumab (Checkpoint Inhibitor)
• Nivolumab (Checkpoint Inhibitor)
• Sunitinib (Tyrosine Kinase Inhibitor)

Trial Overview The study compares the effectiveness of combining Nivolumab (an immune checkpoint inhibitor) with Ipilimumab (another immune-modulating drug) against Sunitinib monotherapy in untreated renal cell cancer patients. It looks at response rate to treatment, how long patients live without their disease getting worse, and overall survival rates.

Participant Groups

Group I: Arm A: Nivolumab 3 mg/kg + Ipilimumab 1 mg/kg Experimental Treatment 2 Interventions

Nivolumab 3 mg/kg combined with Ipilimumab 1 mg/kg solutions intravenously every 3 weeks for 4 doses then Nivolumab 3 mg/kg solutions intravenously every 2 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends

Group II: Arm B: Sunitinib 50 mg Active Control 3 Interventions

Sunitinib 50 mg capsules by mouth once daily for 4 weeks then 2 weeks off, continuously until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends After completion of final analysis eligible participants may switch from receiving Sunitinib to receiving Nivolumab 3 mg/kg IV combined with Ipilimumab 1 mg/kg IV every 3 weeks for 4 doses then Nivolumab 240mg flat dose IV every 2 weeks

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

Ono Pharmaceutical Co. Ltd

Industry Sponsor

Trials

182

Recruited

97,100+

Shinji Takai

Ono Pharmaceutical Co. Ltd

Chief Medical Officer since 2023

MD from an unspecified institution

Gyo Sagara

Ono Pharmaceutical Co. Ltd

Chief Executive Officer since 2024

PhD in Pharmaceutical Sciences from Kyoto University