A Study of Nivolumab Combined With Ipilimumab Versus Nivolumab Alone in Participants With Advanced Kidney Cancer

Bristol-Myers Squibb (BMS)

Status and phase

Active, not recruiting

Phase 3

Conditions

Renal Cell Carcinoma

Treatments

Biological: Ipilimumab

Biological: Nivolumab

Other: Ipilimumab placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT03873402

2018-004695-35 (EudraCT Number)

CA209-8Y8

Details and patient eligibility

About

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.

Enrollment

437 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

Histological confirmation of renal carcinoma with clear cell component including participants who may have sarcomatoid features.
Advanced (not amenable to curative surgery or radiation therapy) renal cell carcinoma (RCC) or metastatic RCC (mRCC).
Measurable disease by computed tomography (CT) or magnetic resonance imaging (MRI) per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) criteria.
No prior systemic therapy for RCC
Must be intermediate or poor risk as per International Metastatic RCC Database Consortium (IMDC).

Exclusion Criteria:

Any active central nervous system (CNS) metastases.
Active, known, or suspected autoimmune disease.
Prior treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, anti-CTLA-4 antibody, or any other agents specifically targeting T-cell co-stimulation or checkpoint pathways

Other protocol-defined inclusion/exclusion criteria apply