A Study of BMS-986449 With and Without Nivolumab in Participants With Advanced Solid Tumors
- Registration Number
- NCT05888831
- Lead Sponsor
- Bristol-Myers Squibb
- Brief Summary
The purpose of this study is to evaluate the safety and efficacy of BMS-986449 alone and in combination with nivolumab in participants with advanced solid tumors.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 100
-
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).
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Dose Escalation: BMS-986449 monotherapy BMS-986449 - Dose Escalation: BMS-986449 + nivolumab BMS-986449 - Dose Escalation: BMS-986449 + nivolumab Nivolumab - Dose Escalation: BMS-986449 monotherapy pharmacodynamic (PD) cohorts BMS-986449 -
- Primary Outcome Measures
Name Time Method Number of participants with Dose-Limiting Toxicities (DLTs) Up to approximately 4 years Number of participants with Adverse Events (AEs) Up to approximately 4 years Number of participants with AEs leading to discontinuation Up to approximately 4 years Number of participants with Serious Adverse Events (SAEs) Up to approximately 4 years Number of deaths Up to approximately 4 years
- Secondary Outcome Measures
Name Time Method Area under the concentration-time curve within a dosing interval (AUC[TAU]) Up to approximately 4 years Time of maximum observed concentration within a dosing interval (Tmax) Up to approximately 4 years Maximum observed plasma concentration (Cmax) Up to approximately 4 years
Trial Locations
- Locations (22)
Institut Bergonie Centre Regional de Lutte Contre Le Cancer de Bordeaux Et Sud Ouest
🇫🇷Bordeaux, France
Local Institution - 0023
🇮🇹Rozzano, Milano, Italy
Local Institution - 0024
🇮🇹Siena, Toscana, Italy
Local Institution - 0026
🇮🇹Bergamo, Italy
Local Institution - 0025
🇮🇹Roma, Italy
Institut Catalan d Oncologia (ICO) - Badalona
🇪🇸Badalona, Barcelona [Barcelona], Spain
Hospital Universitario Fundacion Jimenez Diaz
🇪🇸Madrid, Spain
The Angeles Clinic and Research Institute - West Los Angeles Office
🇺🇸Los Angeles, California, United States
Yale New Haven Hospital-Smilow Cancer Center
🇺🇸New Haven, Connecticut, United States
Hackensack University Medical Center
🇺🇸Hackensack, New Jersey, United States
John Theurer Cancer Center at Hackensack University Medical Center
🇺🇸Hackensack, New Jersey, United States
Northwell Health/ RJ Zuckerberg Cancer Center
🇺🇸Lake Success, New York, United States
Cliniques universitaires Saint-Luc
🇧🇪Brussels, Bruxelles-Capitale, Région De, Belgium
UZ Gent
🇧🇪Gent, Oost-Vlaanderen, Belgium
Gustave Roussy
🇫🇷Villejuif, Paris, France
Institut Paoli-Calmettes
🇫🇷Marseille, Provence-Alpes-Côte-d'Azur, France
Local Institution - 0009
🇫🇷Lyon CEDEX 08, Rhône-Alpes, France
Nederlands Kanker Instituut Antoni van Leeuwenhoek (NKI AVL)
🇳🇱Amsterdam, Noord-Holland, Netherlands
University Medical Center Groningen
🇳🇱Groningen, Netherlands
Hospital Universitario Virgen de la Victoria
🇪🇸Malaga, Andalucía, Spain
Clinica Universidad de Navarra
🇪🇸Pamplona, Navarra, Spain
Hospital Universitario HM Sanchinarro
🇪🇸Madrid, Spain