Advanced Cancer
Conditions
Keywords
Immunotherapy, Relatlimab, Nivolumab, Ipilimumab, BMS-986205
Brief summary
The purpose of this study is to demonstrate the safety and preliminary activity with triple combinations of relatlimab in combination with nivolumab and BMS-986205, or in combination with nivolumab and ipilimumab in immunotherapy-naive and pretreated populations across select advanced tumor types.
Interventions
BIOLOGICALRelatlimab
Specified dose on specified days
BIOLOGICALNivolumab
Specified dose on specified days
DRUGBMS-986205
Specified dose on specified days
BIOLOGICALIpilimumab
Specified dose on specified days
Sponsors
Bristol-Myers Squibb
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Histologic or cytologic confirmation of select incurable solid malignancies that are advanced (metastatic and/or unresectable), with measurable disease per RECIST v1.1 * Available tumor tissue for biomarker analysis * Eastern Cooperative Oncology Group Performance Status (ECOG) status of 0 or 1
Exclusion criteria
* Known or suspected central nervous system (CNS) metastases or with the CNS as the only site of active disease * History of interstitial lung disease / pneumonitis * Prior malignancy active within the previous 2 years except for locally curable cancers that have been cured, such as basal or squamous cell skin cancer * Encephalitis, meningitis, or uncontrolled seizures in the year prior to informed consent Other protocol-defined inclusion/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Median Duration of Response (mDOR) | Approximately 4 years |
| Number of clinical laboratory test abnormalities | Approximately 4 years |
| Number of Adverse Events (AEs) | Approximately 4 years |
| Number of Serious Adverse Events (SAEs) | Approximately 4 years |
| Number of AEs meeting protocol defined dose-limiting toxicity (DLT) criteria | Up to 6 weeks |
| Number of AEs leading to discontinuation | Approximately 4 years |
| Number of AEs leading to death | Approximately 4 years |
| Objective Response Rate (ORR) | Approximately 4 years |
| Disease Control Rate (DCR) | Approximately 4 years |
Secondary
| Measure | Time frame |
|---|---|
| Progression-Free Survival (PFS) | Up to 4 years |
Countries
Australia, France, Italy, Spain, Switzerland, United Kingdom, United States
Outcome results
None listed