Study of Nivolumab (BMS-936558) vs. Everolimus in Pre-Treated Advanced or Metastatic Clear-cell Renal Cell Carcinoma (CheckMate 025)

Recruiting in Palo Alto (17 mi)

+174 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 the study is to compare the clinical benefit, as measured by duration of overall survival, of Nivolumab vs. Everolimus in subjects with advanced or metastatic clear-cell renal cell carcinoma who have received prior anti-angiogenic therapy

Research Team

Bristol-Myers Squibb

Principal Investigator

Bristol-Myers Squibb

Eligibility Criteria

Inclusion Criteria

Men & women ≥18 years of age

Histologic confirmation of renal cell carcinoma (RCC) with clear-cell component

Advanced/metastatic RCC

See 4 more

Treatment Details

Interventions

Everolimus (mTOR inhibitor)
Nivolumab (Checkpoint Inhibitor)

Participant Groups

2Treatment groups

Experimental Treatment

Active Control

Group I: Arm 1: NivolumabExperimental Treatment1 Intervention

Nivolumab 3 mg/kg solution intravenously every 2 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends

Group II: Arm 2: EverolimusActive Control1 Intervention

Everolimus 10 mg tablets by mouth daily until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends

Everolimus is already approved in United States, European Union, United States for the following indications:

🇺🇸 Approved in United States as Afinitor for: