A Study to Evaluate the Safety and Tolerability of BMS-986408 Alone and in Combination With Nivolumab or Nivolumab and Ipilimumab in Participants With Advanced Solid Tumors

Bristol-Myers Squibb (BMS)

Status and phase: Active, not recruiting; Phase 2; Phase 1

Conditions: Advanced Solid Tumors

Treatments: Biological: Platinum-doublet chemotherapy; Biological: Nivolumab; Drug: Rabeprazole; Biological: Ipilimumab; Drug: BMS-986408

Study type: Interventional

Funder types: Industry

Identifiers

NCT05407675

CA099-003

Details and patient eligibility

About

The primary purpose of this study is to characterize the safety profile of BMS-986408 as monotherapy and in combination with nivolumab or nivolumab and ipilimumab to establish the maximum tolerated dose (MTD). The Recommended Phase 2 Dose (RP2D) that optimizes the pharmacokinetic/pharmacodynamic (PK/PD) relationship of BMS-986408 will also be determined.

Enrollment: 402 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Participants with a histologically or cytologically confirmed, advanced, unresectable/metastatic, solid malignancy of any histology measurable by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
• Participants who have received, been refractory to, ineligible for, or intolerant of existing therapy(ies) known to provide clinical benefit for the condition of the participant
• Participants with melanoma should have documentation of mutation status for B-type Raf proto-oncogene (BRAF) and neuroblastoma ras viral oncogene homolog (NRAS)
• Participants must have experienced radiographically documented progressive disease on or after the most recent therapy

Exclusion criteria

• An active, known or suspected autoimmune disease
• Conditions requiring systemic treatment with either corticosteroids within 14 days or other immunosuppressive medications within 30 days of the first dose of study treatment
• Current or recent gastrointestinal disease or gastrointestinal surgery that could impact the absorption of study drug
• Untreated central nervous system (CNS) metastases or leptomeningeal metastasis

Other protocol-defined inclusion/exclusion criteria apply

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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402 participants in 7 patient groups

Part 1: BMS-986408 Monotherapy

Experimental group

Treatment:

Drug: BMS-986408

Part 2: BMS-986408 in combination with nivolumab

Experimental group

Treatment:

Drug: BMS-986408

Biological: Nivolumab

Part 2: BMS-986408 in combination with nivolumab and ipilimumab

Experimental group

Treatment:

Drug: BMS-986408

Biological: Nivolumab

Biological: Ipilimumab

Part 2: BMS-986408 in combination with nivolumab and chemotherapy

Experimental group

Treatment:

Drug: BMS-986408

Biological: Nivolumab

Biological: Platinum-doublet chemotherapy

Part 2: BMS-986408 in combination with rabeprazole

Experimental group

Treatment:

Drug: BMS-986408

Drug: Rabeprazole

Part 3: BMS-986408 in combination with nivolumab

Experimental group

Treatment:

Drug: BMS-986408

Biological: Nivolumab

Part 3: BMS-986408 in combination with nivolumab and chemotherapy

Experimental group

Treatment:

Drug: BMS-986408

Biological: Nivolumab

Biological: Platinum-doublet chemotherapy