BMS-986525 alone and with nivolumab for relapsed or refractory small cell lung cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 1/2 trial gives BMS-986525 by itself and in combination with the checkpoint inhibitor nivolumab to adults with relapsed or refractory small cell lung cancer. Participants must have had at least one platinum-based chemotherapy regimen and, where first-line care includes anti‑PD‑(L)1 therapy, must have progressed on or be ineligible for those drugs. The study uses dose escalation and expansion cohorts to define safety, tolerability, and a recommended dose, with secondary measures of anti-tumor activity. Trial sites include multiple U.S. centers, including Duke Cancer Institute and hospitals in Detroit and Buffalo.

Why it matters

Who can join: the full rules

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.

Where it's running

• Karmanos Cancer Institute
  Detroit, Michigan, United States Recruiting
• Roswell Park Cancer Institute
  Buffalo, New York, United States Recruiting
• Duke Cancer Institute
  Durham, North Carolina, United States Recruiting
• University Hospitals Cleveland Medical Center
  Cleveland, Ohio, United States Recruiting
• SCRI Oncology Partners
  Nashville, Tennessee, United States Recruiting
• Shanghai East Hospital
  Shanghai, Shanghai Municipality, China Recruiting

Study contacts

• Study coordinator: BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
• Email: Clinical.Trials@bms.com
• Phone: 855-907-3286

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.