An Investigational Study of Immunotherapy Combinations in Participants With Solid Cancers That Are Advanced or Have Spread

Bristol-Myers Squibb (BMS)

Status and phase: Completed; Phase 2; Phase 1

Conditions: Advanced Cancer

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT03459222

2018-000058-22 (EudraCT Number)

CA224-048

Details and patient eligibility

About

The purpose of this study is to demonstrate the safety and preliminary activity with triple combinations of relatlimab in combination with nivolumab and BMS-986205, or in combination with nivolumab and ipilimumab in immunotherapy-naive and pretreated populations across select advanced tumor types.

Enrollment: 229 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Histologic or cytologic confirmation of select incurable solid malignancies that are advanced (metastatic and/or unresectable), with measurable disease per RECIST v1.1
• Available tumor tissue for biomarker analysis
• Eastern Cooperative Oncology Group Performance Status (ECOG) status of 0 or 1

Exclusion criteria

• Known or suspected central nervous system (CNS) metastases or with the CNS as the only site of active disease
• History of interstitial lung disease / pneumonitis
• Prior malignancy active within the previous 2 years except for locally curable cancers that have been cured, such as basal or squamous cell skin cancer
• Encephalitis, meningitis, or uncontrolled seizures in the year prior to informed consent

Other protocol-defined inclusion/exclusion criteria apply

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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229 participants in 2 patient groups

Arm A

Experimental group

Description:

Relatlimab + Nivolumab + BMS-986205

Treatment:

Biological: Relatlimab

Biological: Nivolumab

Drug: BMS-986205

Arm B

Experimental group

Description:

Relatlimab + Nivolumab + Ipilimumab

Treatment:

Biological: Relatlimab

Biological: Nivolumab

Biological: Ipilimumab