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

Purpose

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

Condition

  • Relapsed/Refractory Small Cell Lung Cancer

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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

Phase
Phase 1/Phase 2
Study Type
Interventional
Allocation
Non-Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Part 1A: BMS-986525 Monotherapy Dose Escalation
  • Drug: BMS-986525
    Specified dose on specified days
Experimental
Part 1B: BMS-986525 Combination with Nivolumab Dose Escalation
  • Drug: BMS-986525
    Specified dose on specified days
  • Drug: Nivolumab
    Specified dose on specified days
    Other names:
    • Opdivo
Experimental
Part 2A: BMS-986525 Monotherapy Dose Expansion
  • Drug: BMS-986525
    Specified dose on specified days
Experimental
Part 2B: BMS-986525 Combination with Nivolumab Dose Expansion
  • Drug: BMS-986525
    Specified dose on specified days
  • Drug: Nivolumab
    Specified dose on specified days
    Other names:
    • Opdivo

Recruiting Locations

Duke Cancer Institute
Durham, North Carolina 27710
Contact:
Neal Ready, Site 0005
919-681-7460

University Hospitals Cleveland Medical Center
Cleveland, Ohio 44106
Contact:
Afshin Dowlati, Site 0004
216-844-5432

SCRI Oncology Partners
Nashville, Tennessee 37203
Contact:
Melissa Johnson, Site 0006
615-329-7274

More Details

Status
Recruiting
Sponsor
Bristol-Myers Squibb

Study Contact

BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
855-907-3286
Clinical.Trials@bms.com