BMS-986525 alone and with nivolumab for relapsed or refractory small cell lung cancer
A Phase 1/2 Study of BMS-986525 as Monotherapy and in Combination With Nivolumab in Participants With Relapsed/Refractory Small Cell Lung Cancer
PHASE1; PHASE2 · Bristol-Myers Squibb · NCT07325136
This trial will test whether BMS-986525, alone or together with nivolumab, is safe and tolerable for people whose small cell lung cancer has returned or not responded to prior platinum chemotherapy.
Quick facts
| Phase | PHASE1; PHASE2 |
|---|---|
| Study type | Interventional |
| Enrollment | 240 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Bristol-Myers Squibb (industry) |
| Drugs / interventions | chemotherapy, Nivolumab |
| Locations | 11 sites (Detroit, Michigan and 10 other locations) |
| Trial ID | NCT07325136 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults with histologically confirmed relapsed or refractory SCLC who have received at least one platinum-based chemotherapy and, where applicable, have progressed on or are ineligible for anti‑PD‑(L)1 therapy and can attend a participating U.S. site.
Not a fit: Patients with untreated central nervous system metastases, active autoimmune disease, prior organ or tissue transplant, or other protocol exclusions are unlikely to benefit or be eligible.
Why it matters
Potential benefit: If successful, this approach could provide a new, tolerable treatment option that may improve disease control for people with relapsed or refractory SCLC.
How similar studies have performed: Other trials combining immune checkpoint inhibitors with novel agents in SCLC have produced some responses but durable benefits have been limited, so combination approaches remain experimental.
Eligibility criteria
Show full inclusion / 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.
Where this trial is running
Detroit, Michigan and 10 other locations
- Local Institution - 0011 — Detroit, Michigan, United States (NOT_YET_RECRUITING)
- Local Institution - 0026 — Buffalo, New York, United States (NOT_YET_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)
- Local Institution - 0001 — Rozzano, Milano, Italy (NOT_YET_RECRUITING)
- Local Institution - 0020 — Hirakata, Osaka, Japan (NOT_YET_RECRUITING)
- Local Institution - 0018 — Chuo-ku, Tokyo, Japan (NOT_YET_RECRUITING)
- Local Institution - 0023 — Timișoara, Timiș County, Romania (NOT_YET_RECRUITING)
- Local Institution - 0003 — Craiova, Romania (NOT_YET_RECRUITING)
- Local Institution - 0009 — Madrid, Spain (NOT_YET_RECRUITING)
Study contacts
- Study coordinator: BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
- Email: Clinical.Trials@bms.com
- Phone: 855-907-3286
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Relapsed/Refractory Small Cell Lung Cancer, Extensive stage-small cell lung cancer