A Study to Evaluate the Safety and Efficacy of Nivolumab With Ipilimumab in Participants With Untreated Advanced Kidney Cancer Conducted in India (CheckMate 7C9)

Bristol-Myers Squibb (BMS)

Status and phase

Completed

Phase 4

Conditions

Kidney Neoplasms

Treatments

Biological: Nivolumab

Biological: Ipilimumab

Study type

Interventional

Funder types

Industry

Identifiers

NCT04513522

CA209-7C9

Details and patient eligibility

About

The purpose of this study is to assess the safety and efficacy of nivolumab combined with ipilimumab in intermediate and poor-risk participants with previously untreated advanced renal cell carcinoma (RCC) or metastatic RCC (mRCC) in India.

Enrollment

101 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Histological confirmation of renal cell carcinoma (RCC) with clear cell component including participants who may have sarcomatoid features
Qualifies as intermediate or poor risk by meeting at least one of the prognostic factors as per the International Metastatic RCC Database Consortium (IMDC) criteria
Indian participants with Indian ethnicity living in India
No prior systemic therapy for RCC
Measurable disease lesion by computed tomography (CT) or magnetic resonance imaging (MRI) per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria

Exclusion criteria

Participants with active, untreated, symptomatic central nervous system (CNS) metastases
Major surgery less than 28 days prior to the first dose of study treatment
Participants with an autoimmune disease, or any other condition, requiring systemic treatment with either corticosteroids or other immunosuppressive medications

Other protocol-defined inclusion/exclusion criteria apply