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

Conditions

• Advanced or Metastatic (Medically or Surgically Unresectable) Clear-cell Renal Cell Carcinoma

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Nivolumab — BIOLOGICAL
• Everolimus — DRUG

Study Details

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

Key Dates

Start date

Oct 9, 2012

Status verified

Jul 2022

Primary completion

May 6, 2015

Completion

Jul 19, 2021

Study Design

Enrollment

821 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Arm 1: Nivolumab
  Nivolumab 3 mg/kg solution intravenously every 2 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends
• Active Comparator: Arm 2: Everolimus
  Everolimus 10 mg tablets by mouth daily until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends

Primary Outcome Measure

Overall Survival (OS) at Primary Endpoint [ Time Frame: Randomization until 398 deaths, up to May 2015 (approximately 30 months) ]

Locations (39)

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