A Study to Test Combination Treatments in People With Advanced Renal Cell Carcinoma (FRACTION-RCC)

Bristol-Myers Squibb (BMS)

Status and phase: Completed; Phase 2

Conditions: Advanced Cancer

Treatments: Biological: Relatlimab; Biological: Ipilimumab; Drug: BMS-986205; Drug: BMS-813160; Biological: Nivolumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT02996110

CA018-005

2016-003082-26 (EudraCT Number)

Details and patient eligibility

About

The purpose of this study is to test the effectiveness and safety of various nivolumab combinations compared to nivolumab and ipilimumab in participants with advanced kidney cancer

Enrollment: 182 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Advanced Renal Cell Carcinoma
• Must have at least 1 lesion with measurable disease
• Life expectancy of at least 3 months
• Karnofsky Performance Status (KPS) must be =>70%

Exclusion criteria

• Patients/subjects with suspected or known central nervous system metastases unless adequately treated
• Patients/subjects with autoimmune disease
• Patients/subjects who need daily oxygen therapy

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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182 participants in 4 patient groups

Nivolumab + Ipilimumab

Active Comparator group

Description:

Nivolumab + Ipilimumab

Treatment:

Biological: Nivolumab

Biological: Ipilimumab

Nivolumab + Relatlimab

Experimental group

Description:

Nivolumab + Relatlimab

Treatment:

Biological: Nivolumab

Biological: Relatlimab

Nivolumab + BMS-986205

Experimental group

Description:

Nivolumab + BMS-986205

Treatment:

Drug: BMS-986205

Biological: Nivolumab

Nivolumab + BMS-813160

Experimental group

Description:

Nivolumab + BMS-813160 (CCR2/5 dual antagonist)

Treatment:

Biological: Nivolumab

Drug: BMS-813160