Testing BMS-986482 for advanced solid tumors
A Phase 1/2 Study of BMS-986482 as Monotherapy or Combination Therapy in Participants With Advanced Solid Tumors
PHASE1; PHASE2 · Bristol-Myers Squibb · NCT06697197
This study is testing a new treatment called BMS-986482, alone and with other therapies, to see if it can help people with advanced solid tumors who haven't had success with other treatments.
Quick facts
| Phase | PHASE1; PHASE2 |
|---|---|
| Study type | Interventional |
| Enrollment | 413 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Bristol-Myers Squibb (industry) |
| Locations | 21 sites (Irvine, California and 20 other locations) |
| Trial ID | NCT06697197 on ClinicalTrials.gov |
What this trial studies
This study evaluates the safety and effectiveness of BMS-986482, both alone and in combination with other therapies, for patients with advanced solid tumors. Participants will be enrolled based on specific cancer types and prior treatment history, including those who have not responded to existing therapies. The study aims to assess how well these treatments work in managing advanced malignancies, utilizing various immuno-oncology approaches.
Who should consider this trial
Good fit: Ideal candidates include adults with advanced, unresectable solid tumors who have previously received or are intolerant to standard therapies.
Not a fit: Patients with early-stage tumors or those who have not yet undergone standard treatment options may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a new treatment option for patients with advanced solid tumors who have limited alternatives.
How similar studies have performed: Other studies have shown promise with similar immuno-oncology approaches, indicating potential for success in this area.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * All participants must have a histologically or cytologically confirmed, advanced, unresectable/metastatic, solid malignancy measurable by RECIST v1.1, and have received, be refractory to, ineligible for, intolerant of, or refused existing therapy(ies) known to provide clinical benefit for the condition of the participant. * Participant must be ≥ 18 years or the legal age of consent in the jurisdiction in which the study is taking place, inclusive, at the time of signing the ICF. Exclusion Criteria: * History of life threatening immune mediated toxicity related to prior T-cell agonist or checkpoint inhibitor therapy, except those that are unlikely to re-occur with standard countermeasures. * Any significant acute or chronic medical illness which would interfere with study intervention or follow-up in the opinion of the investigator. * Other protocol-defined Inclusion/Exclusion criteria apply.
Where this trial is running
Irvine, California and 20 other locations
- University of California, Irvine (UCI) Health - UC Irvine Medical Center — Irvine, California, United States (RECRUITING)
- The Angeles Clinic and Research Institute - West Los Angeles Office — Los Angeles, California, United States (RECRUITING)
- Local Institution - 0008 — Aurora, Colorado, United States (NOT_YET_RECRUITING)
- John Theurer Cancer Center at Hackensack University Medical Center — Hackensack, New Jersey, United States (RECRUITING)
- Northwell Health/ RJ Zuckerberg Cancer Center — Lake Success, New York, United States (RECRUITING)
- Levine Cancer Institute — Charlotte, North Carolina, United States (RECRUITING)
- Fred Hutchinson Cancer Center — Seattle, Washington, United States (RECRUITING)
- UZ Gent — Ghent, Oost-Vlaanderen, Belgium (RECRUITING)
- Rigshospitalet — Copenhagen, Capital Region, Denmark (RECRUITING)
- Assistance Publique Hôpitaux de Marseille - Hôpital de la Timone — Marseille, Bouches-du-Rhône, France (RECRUITING)
- Gustave Roussy — Villejuif, Paris, France (RECRUITING)
- General Hospital of Athens "Laiko" — Athens, Attikí, Greece (RECRUITING)
- Papageorgiou General Hospital of Thessaloniki — Thessaloniki, Thessaloníki, Greece (RECRUITING)
- Fondazione IRCCS Istituto Nazionale dei Tumori — Milan, Lombardy, Italy (RECRUITING)
- Istituto Clinico Humanitas — Rozzano, Milano, Italy (RECRUITING)
- Nederlands Kanker Instituut Antoni van Leeuwenhoek (NKI AVL) — Amsterdam, North Holland, Netherlands (RECRUITING)
- Erasmus Medisch Centrum — Rotterdam, Netherlands (RECRUITING)
- Hospital Universitari Vall d'Hebron — Barcelona, Barcelona [Barcelona], Spain (RECRUITING)
- Clinica Universidad de Navarra — Pamplona, Navarre, Spain (RECRUITING)
- Hospital Universitario HM Sanchinarro — Madrid, Spain (RECRUITING)
- Karolinska Universitetssjukhuset Solna — Solna, Stockholms Län [se-01], Sweden (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: Advanced Solid Tumors, Immuno-oncology, Regulatory T cells, Tregs