Evaluating BMS-986449 with and without Nivolumab for advanced solid tumors
A Phase 1/2 Study of BMS-986449 Alone and in Combination With Nivolumab in Participants With Advanced Solid Tumors
This study is testing a new treatment called BMS-986449, alone and with another drug called nivolumab, to see if it helps people with advanced solid tumors like lung and breast cancer who haven't responded to other therapies.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Bristol-Myers Squibb Industry-sponsored |
| Drugs / interventions | nivolumab |
| Locations | 22 sites (Los Angeles, California and 21 other locations) |
| Trial ID | NCT05888831 on ClinicalTrials.gov |
What this trial studies
This study aims to assess the safety and effectiveness of BMS-986449, both alone and in combination with nivolumab, in patients suffering from advanced solid tumors. Participants must have confirmed advanced, unresectable, or metastatic solid malignancies and have previously received or been intolerant to existing therapies. The study is divided into three parts, focusing on different types of solid tumors, including non-small cell lung cancer and triple-negative breast cancer. Tumor biopsies will be collected to evaluate the response to treatment.
Who should consider this trial
Good fit: Ideal candidates include individuals with advanced, unresectable solid tumors who have not responded to or are intolerant of existing therapies.
Not a fit: Patients with a history of severe toxicity from prior T-cell agonist or checkpoint inhibitor therapies 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 therapeutic alternatives.
How similar studies have performed: Other studies have shown promise with similar immunotherapy 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 Response Evaluation Criteria in Solid Tumors \[RECIST\] v1.1), and have received, be refractory to, ineligible for, or intolerant of existing therapy(ies) known to provide clinical benefit for the condition of the participant. * Part 1A may have a solid malignancy of any histology. * Part 1B is restricted to participants with Non-small cell lung cancer (NSCLC). * Part 1C is restricted to participants with Triple-negative breast cancer (TNBC). * Tumor biopsy must be obtained for all participants (unless medically precluded). Exclusion Criteria: * History of Grade ≥ 3 toxicity related to prior T-cell agonist or checkpoint inhibitor therapy (eg, anti-cytotoxic T-lymphocyte-associated antigen 4 \[CTLA-4\], or anti-PD- 1/programmed death-ligand 1 \[PD-L1\] treatment, or any other antibody or drug specifically targeting T-cell co-stimulation or other immune checkpoint pathways) except those that are unlikely to re-occur with standard countermeasures. * Current or recent (within 3 months of study intervention administration) gastrointestinal disease or gastrointestinal surgery (eg, intestinal/gastric/colon resection) that could impact the absorption of study intervention. * 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 criteria may apply.
Where this trial is running
Los Angeles, California and 21 other locations
- The Angeles Clinic and Research Institute - West Los Angeles Office — Los Angeles, California, United States (Recruiting)
- Yale New Haven Hospital-Smilow Cancer Center — New Haven, Connecticut, United States (Recruiting)
- Hackensack University Medical Center — Hackensack, New Jersey, United States (Withdrawn)
- 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)
- Cliniques universitaires Saint-Luc — Brussels, Bruxelles-Capitale, Région De, Belgium (Recruiting)
- UZ Gent — Gent, Oost-Vlaanderen, Belgium (Recruiting)
- Gustave Roussy — Villejuif, Paris, France (Recruiting)
- Institut Paoli-Calmettes — Marseille, Provence-Alpes-Côte-d'Azur, France (Recruiting)
- Local Institution - 0009 — Lyon CEDEX 08, Rhône-Alpes, France (Withdrawn)
- Institut Bergonie Centre Regional de Lutte Contre Le Cancer de Bordeaux Et Sud Ouest — Bordeaux, France (Recruiting)
- Local Institution - 0023 — Rozzano, Milano, Italy (Completed)
- Local Institution - 0024 — Siena, Toscana, Italy (Completed)
- Local Institution - 0026 — Bergamo, Italy (Completed)
- Local Institution - 0025 — Roma, Italy (Completed)
- Nederlands Kanker Instituut Antoni van Leeuwenhoek (NKI AVL) — Amsterdam, Noord-Holland, Netherlands (Recruiting)
- University Medical Center Groningen — Groningen, Netherlands (Recruiting)
- Hospital Universitario Virgen de la Victoria — Malaga, Andalucía, Spain (Recruiting)
- Institut Catalan d Oncologia (ICO) - Badalona — Badalona, Barcelona [Barcelona], Spain (Recruiting)
- Clinica Universidad de Navarra — Pamplona, Navarra, Spain (Recruiting)
- Hospital Universitario Fundacion Jimenez Diaz — Madrid, Spain (Recruiting)
- Hospital Universitario HM Sanchinarro — Madrid, Spain (Recruiting)
Study contacts
- Study coordinator: BMS Study Connect Contact Center www.BMSStudyConnect.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.