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

Bristol-Myers Squibb (BMS)

Status and phase: Completed; Phase 3

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

Treatments: Drug: Everolimus; Biological: Nivolumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT01668784

2011-005132-26 (EudraCT Number)

CA209-025

Details and patient eligibility

About

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

Enrollment: 821 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Men & women ≥18 years of age
• Histologic confirmation of renal cell carcinoma (RCC) with clear-cell component
• Advanced/metastatic RCC
• Measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria
• Received 1 or 2 prior anti-angiogenic therapy regimens in advanced or metastatic setting
• No more than 3 total prior systemic treatment regimens in the advanced or metastatic setting, and evidence of progression on or after last treatment regimen received and within 6 months of enrollment
• Karnofsky Performance Score ≥70%

Exclusion criteria

• Any Central Nervous System (CNS) metastases or history of CNS metastases
• Prior therapy with an Mammalian target of rapamycin (mTOR) inhibitor
• Any active known or suspected autoimmune disease
• Uncontrolled adrenal insufficiency
• Active chronic liver disease
• Prior malignancy active within past 3 years, except for locally curable cancers

Other protocol-defined inclusion/exclusion criteria apply

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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821 participants in 2 patient groups

Arm 1: Nivolumab

Experimental group

Description:

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

Treatment:

Biological: Nivolumab

Arm 2: Everolimus

Active Comparator group

Description:

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

Treatment:

Drug: Everolimus