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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

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

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.