Advanced Solid Tumors
Conditions
Keywords
BMS-986449, Nivolumab, Cancer, Solid Tumors, Non-Small Cell Lung Cancer (NSCLC), Triple Negative Breast Cancer (TNBC)
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.
Interventions
DRUGBMS-986449
Specified dose on specified days
DRUGNivolumab
Specified dose on specified days
Sponsors
Bristol-Myers Squibb
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of deaths | Up to approximately 4 years |
| Number of participants with Adverse Events (AEs) | Up to approximately 4 years |
| Number of participants with Serious Adverse Events (SAEs) | Up to approximately 4 years |
| Number of participants with AEs leading to discontinuation | Up to approximately 4 years |
| Number of participants with Dose-Limiting Toxicities (DLTs) | Up to approximately 4 years |
Secondary
| Measure | Time frame |
|---|---|
| Time of maximum observed concentration within a dosing interval (Tmax) | Up to approximately 4 years |
| Area under the concentration-time curve within a dosing interval (AUC[TAU]) | Up to approximately 4 years |
| Maximum observed plasma concentration (Cmax) | Up to approximately 4 years |
Countries
Belgium, France, Italy, Netherlands, Spain, United States
Outcome results
None listed