A Study to Assess the Safety and Tolerability of BMS-986525 Alone and in Combination With Nivolumab in Participants With Relapsed/Refractory Small Cell Lung Cancer

Bristol-Myers Squibb (BMS)

Status and phase: Begins enrollment in 1 month; Phase 2; Phase 1

Conditions: Relapsed/Refractory Small Cell Lung Cancer

Treatments: Drug: BMS-986525; Drug: Nivolumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT07325136

CA258-0001

2025-524090-16 (Other Identifier)

Details and patient eligibility

About

The purpose of this study is to assess the safety and tolerability of BMS-986525 alone and in combination with Nivolumab in participants with Relapsed/Refractory Small Cell Lung Cancer

Enrollment: 240 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria

• Participants must have histologically or cytologically documented relapsed/refractory small cell lung cancer (R/R-SCLC).
• Participants must have received at least 1 platinum-based chemotherapy regimen as per locally approved drug labels and institutional guidelines.
• In countries where standard of care first line systemic treatment includes platinum containing chemotherapy in combination with anti-PD-(L)1 therapy, it is required that participants have progressed on, are ineligible for or not have access to an anti-PD- (L)1 therapy.

Exclusion Criteria

• Participants must not have any untreated CNS metastases.
• Participants must not have an active, known or suspected autoimmune disease.
• Participants must not have had a prior organ or tissue allograft.
• 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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240 participants in 4 patient groups

Part 1A: BMS-986525 Monotherapy Dose Escalation

Experimental group

Treatment:

Drug: BMS-986525

Part 1B: BMS-986525 Combination with Nivolumab Dose Escalation

Experimental group

Treatment:

Drug: Nivolumab

Drug: BMS-986525

Part 2A: BMS-986525 Monotherapy Dose Expansion

Experimental group

Treatment:

Drug: BMS-986525

Part 2B: BMS-986525 Combination with Nivolumab Dose Expansion

Experimental group

Treatment:

Drug: Nivolumab

Drug: BMS-986525