A Study of BMS-986442 With Nivolumab With or Without Chemotherapy in Solid Tumors and Non-small Cell Lung Cancer

Bristol-Myers Squibb (BMS)

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

Conditions: Advanced Solid Tumors; Non-small Cell Lung Cancer

Treatments: Drug: Carboplatin; Drug: Pemexetred; Drug: Docetaxel; Drug: Paclitaxel; Biological: Nivolumab; Biological: BMS-986442

Study type: Interventional

Funder types: Industry

Identifiers

NCT05543629

U1111-1283-1243 (Registry Identifier)

2022-501676-26 (EudraCT Number)

CA115-001

Details and patient eligibility

About

The purpose of this study is to evaluate BMS-986442 in combination with nivolumab (with or without chemotherapy) for its antitumor efficacy and benefit to participants.

Enrollment: 225 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Participants in all parts of the study must have measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.
• Participants must have an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.
• Participants must have a life expectancy of at least 3 months at the time of first dose.

Exclusion criteria

• Untreated symptomatic central nervous system metastases or leptomeningeal metastases.
• Concurrent malignancy (present during screening) requiring treatment, or history of prior malignancy active within 2 years prior to randomization in study Part B1 or treatment assignment in all other study parts.
• Participants with an active, known, or suspected autoimmune disease.

Other protocol-defined inclusion/exclusion criteria apply.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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225 participants in 6 patient groups

Part A: BMS-986442 + Nivolumab

Experimental group

Treatment:

Biological: BMS-986442

Biological: Nivolumab

Part B1: BMS-986442 + Nivolumab

Experimental group

Description:

Second line (2L) + Post-immuno-oncology (IO)/Platinum-Doublet Non-small cell lung cancer (NSCLC)

Treatment:

Biological: BMS-986442

Biological: Nivolumab

Part B2: BMS-986442 + Nivolumab

Experimental group

Description:

Post IO Gastric Cancer/Gastroesophageal Junction and Post-IO squamous cell carcinoma of the head and neck (SCCHN)

Treatment:

Biological: BMS-986442

Biological: Nivolumab

Part C: BMS-986442 + Nivolumab + Docetaxel

Experimental group

Treatment:

Biological: BMS-986442

Biological: Nivolumab

Drug: Docetaxel

Part D: BMS-986442 + Nivolumab + Carboplatin + Pemetrexed

Experimental group

Treatment:

Biological: BMS-986442

Biological: Nivolumab

Drug: Pemexetred

Drug: Carboplatin

Part E: BMS-986442 + Nivolumab + Carboplatin + Paclitaxel

Experimental group

Treatment:

Biological: BMS-986442

Drug: Paclitaxel

Biological: Nivolumab

Drug: Carboplatin