Recruiting
Phase 1
Phase 2

BMS-986525 & Nivolumab

Sponsor:

Bristol-Myers Squibb

Code:

NCT07325136

Conditions

Relapsed/Refractory Small Cell Lung Cancer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

BMS-986525

Pumitamig

Study Details

Brief summary:

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

Conditions

Relapsed/Refractory Small Cell Lung Cancer

Study ID

NCT07325136

Start date

Feb 3, 2026

Status verified date

Aug, 2026

Completion date

Apr 24, 2029

Anticipated

Primary completion date

Apr 23, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

240 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Part 1A: BMS-986525 Monotherapy Dose Escalation

experimental: Part 2A: BMS-986525 Monotherapy Dose Expansion

experimental: Part 1B: BMS-986525 Combination with Pumitamig Dose Escalation

experimental: Part 2B: BMS-986525 Combination with Pumitamig Dose Expansion

Interventions

BMS-986525

Specified dose on specified days

Pumitamig

Specified dose on specified days

Primary outcome measure

  • Number of participants with adverse events (AEs) [ Time Frame: Up to approximately 2 years ]
  • Number of participants with serious adverse events (SAEs) [ Time Frame: Up to approximately 2 years ]
  • Number of participants with AEs meeting dose-limiting toxicity (DLT) criteria [ Time Frame: Up to 21 days ]
  • Number of participants with AEs leading to discontinuation [ Time Frame: Up to approximately 2 years ]
  • Number of participants with AEs leading to death [ Time Frame: Up to approximately 2 years ]

Central Contacts and Locations

Central contacts

BMS Clinical Trials Contact Center www.BMSClinicalTrials.com

855-907-3286Clinical.Trials@bms.com

Locations

Karmanos Cancer Institute

Recruiting

Detroit, Michigan, United States, 48201

Contacts

Hirva Mamdani, Site 0011

313-576-8711

Duke Cancer Institute

Recruiting

Durham, North Carolina, United States, 27710

Contacts

Neal Ready, Site 0005

919-681-7460

University Hospitals Cleveland Medical Center

Recruiting

Cleveland, Ohio, United States, 44106

Contacts

Afshin Dowlati, Site 0004

216-844-5432

SCRI Oncology Partners

Recruiting

Nashville, Tennessee, United States, 37203

Contacts

Melissa Johnson, Site 0006

615-329-7274

More Information

Sponsor

Bristol-Myers Squibb

Last update posted

Aug 18, 2026

Last verified

Aug, 2026

Keywords

  • Extensive stage-small cell lung cancer (ES-SCLC)

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Bristol-Myers Squibb on 2026-08-18.