A Study to Evaluate the Safety, Tolerability, Drug Levels, and Preliminary Efficacy of BMS-986507 Combinations in Adult Participants With Advanced Solid Tumors
- Conditions
- Lung Cancer
- Interventions
- Registration Number
- NCT06618287
- Lead Sponsor
- Bristol-Myers Squibb
- Brief Summary
The purpose of this study is to evaluate the safety, tolerability, drug levels, and preliminary efficacy of BMS-986507 combinations in adult participants with advanced solid tumors.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 218
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Group A BMS-986507 - Group A Osimertinib - Group B BMS-986507 - Group B Pembrolizumab -
- Primary Outcome Measures
Name Time Method Number of participants with adverse events (AEs) Up to 3 years Number of participants with serious adverse events (SAEs) Up to 3 years Number of participants with AEs meeting protocol defined dose-limiting toxicity (DLT) critera Up to 3 years Number of participants with AEs leading to discontinuation Up to 3 years Number of participants with AEs leading to death Up to 3 years Number of DLTs that occur during the DLT evaluation period Up to 3 weeks
- Secondary Outcome Measures
Name Time Method Maximum observed serum concentration (Cmax) Up to 3 years Time of maximum observed concentration (Tmax) Up to 3 years Area under the concentration-time curve from time zero to time of last quantifiable concentration (AUC(0-T)) Up to 3 years Area under the serum concentration-time curve within a dosing interval (AUC(TAU)) Up to 3 years Objective response rate (ORR) Up to 3 years Duration of response (DOR) Up to 3 years
Trial Locations
- Locations (47)
Local Institution - 0066
🇺🇸Birmingham, Alabama, United States
Liverpool Hospital
🇦🇺Liverpool, New South Wales, Australia
The Ottawa Hospital - General Campus
🇨🇦Ottawa, Ontario, Canada
Local Institution - 0065
🇺🇸Iowa City, Iowa, United States
Local Institution - 0009
🇺🇸Miami, Florida, United States
John Theurer Cancer Center at Hackensack University Medical Center
🇺🇸Hackensack, New Jersey, United States
Cleveland Clinic
🇺🇸Cleveland, Ohio, United States
Local Institution - 0052
🇺🇸Portland, Oregon, United States
Local Institution - 0014
🇺🇸Pittsburgh, Pennsylvania, United States
Swedish Medical Center
🇺🇸Seattle, Washington, United States
Princess Alexandra Hospital
🇦🇺Woolloongabba, Queensland, Australia
Local Institution - 0024
🇨🇦Edmonton, Alberta, Canada
Local Institution - 0064
🇨🇦Newmarket, Ontario, Canada
Local Institution - 0023
🇨🇦Ottawa, Ontario, Canada
Local Institution - 0032
🇮🇹Roma, Italy
Jewish General Hospital
🇨🇦Montreal, Quebec, Canada
Centre Hospitalier de l'Université de Montréal
🇨🇦Montréal, Quebec, Canada
Local Institution - 0048
🇨🇱Santiago, Región Metropolitana De Santiago, Chile
Local Institution - 0049
🇨🇱Santiago, Región Metropolitana De Santiago, Chile
Local Institution - 0047
🇨🇱Santiago, Región Metropolitana De Santiago, Chile
Local Institution - 0043
🇫🇷Bordeaux, Aquitaine, France
Local Institution - 0045
🇫🇷Marseille, Bouches-du-Rhône, France
Local Institution - 0053
🇫🇷Montpellier, Hérault, France
Local Institution - 0050
🇫🇷Lyon, Rhône-Alpes, France
Local Institution - 0041
🇫🇷Villejuif, Val-de-Marne, France
Local Institution - 0054
🇫🇷Paris, France
Local Institution - 0040
🇫🇷Paris, France
Local Institution - 0034
🇮🇹Aviano, Friuli-Venezia Giulia, Italy
Local Institution - 0033
🇮🇹Milan, Lombardia, Italy
Local Institution - 0056
🇮🇹Candiolo, Torino, Italy
Local Institution - 0035
🇮🇹Firenze, Toscana, Italy
Local Institution - 0004
🇳🇱Leiden, Zuid-Holland, Netherlands
Local Institution - 0003
🇳🇱Amsterdam, Netherlands
Local Institution - 0062
🇪🇸Santiago de Compostela, A Coruña [La Coruña], Spain
Local Institution - 0016
🇪🇸Barcelona, Barcelona [Barcelona], Spain
Local Institution - 0058
🇪🇸Hospitalet, Barcelona [Barcelona], Spain
Local Institution - 0059
🇪🇸Barcelona, Catalunya [Cataluña], Spain
Local Institution - 0018
🇪🇸Madrid, Madrid, Comunidad De, Spain
Local Institution - 0061
🇪🇸Majadahonda, Madrid, Comunidad De, Spain
Local Institution - 0017
🇪🇸Madrid, Spain
Local Institution - 0019
🇪🇸Madrid, Spain
Local Institution - 0063
🇪🇸Málaga, Spain
Local Institution - 0060
🇪🇸València, Spain
Local Institution - 0020
🇬🇧Birmingham, England, United Kingdom
Local Institution - 0030
🇬🇧London, England, United Kingdom
Local Institution - 0021
🇬🇧Glasgow, Glasgow City, United Kingdom
Local Institution - 0001
🇬🇧Newcastle upon Tyne, United Kingdom