A Study of BMS-986207 Given Alone and in Combination With Nivolumab or With Nivolumab and Ipilimumab in Advanced Solid Tumors

Bristol-Myers Squibb (BMS)

Status and phase: Completed; Phase 2; Phase 1

Conditions: Broad Solid Tumor

Treatments: Biological: Nivolumab; Biological: Ipilimumab; Drug: BMS-986207

Study type: Interventional

Funder types: Industry

Identifiers

NCT02913313

2016-002263-34 (EudraCT Number)

CA020-002

Details and patient eligibility

About

The purpose of this study is to evaluate the safety and effectiveness of experimental medication BMS-986207 by itself, in combination with Nivolumab, and in combination with both nivolumab and ipilimumab in participants with solid cancers that are advanced or have spread.

Enrollment: 101 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Must have pre-existing or prior programmed death-ligand 1 (PD-L1) immunohistochemistry (IHC) results within 3 months of enrollment from testing of tumor tissue; PD-L1 expression must be tumor cell positive ≥ 1% for a participant to be eligible for enrollment
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
• Measurable disease by computed tomography (CT) or magnetic resonance imaging (MRI) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 criteria; radiographic tumor assessment performed within 28 days before randomization

Exclusion criteria

• Primary central nervous system (CNS) disease, or tumors with CNS metastases as the only site of disease. Controlled brain metastases will be allowed to enroll
• Other active malignancy requiring concurrent intervention
• Uncontrolled or significant cardiovascular disease
• Active, known, or suspected autoimmune disease
• NSCLC without prior treatment in the advanced or metastatic setting (Part 2C)

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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101 participants in 6 patient groups

Part 1A: Dose Escalation Monotherapy

Experimental group

Treatment:

Drug: BMS-986207

Part 1B: Dose Escalation Combination Therapy

Experimental group

Treatment:

Drug: BMS-986207

Biological: Nivolumab

Part 2A: Expansion Monotherapy

Experimental group

Treatment:

Drug: BMS-986207

Part 2B: Expansion Combination Therapy

Experimental group

Treatment:

Drug: BMS-986207

Biological: Nivolumab

Part 1C: Triplet Cohort

Experimental group

Treatment:

Drug: BMS-986207

Biological: Ipilimumab

Biological: Nivolumab

Part 2C: Triplet Expansion

Experimental group

Treatment:

Drug: BMS-986207

Biological: Ipilimumab

Biological: Nivolumab