Advanced Solid Tumors
Conditions
Keywords
Advanced Solid Tumors, Relatlimab, Nivolumab
Brief summary
The purpose of this study is to evaluate the safety and drug levels of relatlimab combined with nivolumab in Chinese participants with advanced solid tumors.
Interventions
BIOLOGICALRelatlimab
Specified dose on specified days
BIOLOGICALNivolumab
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
* Participants must have histologic or cytological confirmation of an incurable solid malignancy that is advanced (metastatic and/or unresectable) except for participants with primary central nervous system (CNS) tumors. * Participants must have received, and then progressed or been intolerant to at least 1 standard treatment regimen in the advanced or metastatic setting (immune check inhibitor-experienced or non-experienced population may be included), if such a therapy exists. Participants who refuse or are ineligible for standard therapy will be allowed to enroll provided their refusal/ineligibility is documented in medical records. * Eastern Cooperative Oncology Group (ECOG) 0 to 1.
Exclusion criteria
* Participants with history of severe and/or life-threatening toxicity related to prior immune therapy (eg, anti-cytotoxic T-lymphocyte-associated protein 4 \[anti-CTLA-4\] or anti-programmed cell death protein 1 \[anti-PD-1\]/programmed death-ligand 1 \[PD-L1\] treatment or any other antibody or drug specifically targeting T cell co-stimulation or immune checkpoint pathways) except those that are unlikely to re-occur with standard countermeasures (eg, hormone replacement after endocrinopathy). * Participants with an active, known, or suspected autoimmune disease. Participants with type I diabetes mellitus, hypothyroidism only requiring hormone replacement, skin disorders (such as vitiligo, psoriasis, or alopecia) not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are permitted to enroll. * Prior treatment with LAG-3 targeted agents. Other protocol-defined inclusion/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Maximum Observed Plasma Concentration (Cmax) of Relatlimab | Up to 123 Weeks |
| Trough-observed serum concentration (Ctrough) of Relatlimab | Up to 123 Weeks |
| Number of Participants with Adverse Events (AEs) | Up to 123 Weeks |
| Number of Participants with Immune-mediated Adverse Events (IMAEs) | Up to 123 Weeks |
| Number of Participants with Serious Adverse Events (SAEs) | Up to 123 Weeks |
| Number of Deaths | Up to 123 Weeks |
| Number of Participants with AEs Leading to Discontinuation | Up to 123 Weeks |
| Number of Participants with Dose-Limiting Toxicities (DLTs) | Up to 123 Weeks |
| Number of Participants with Clinical Laboratory Abnormalities | Up to 123 Weeks |
| Time of Maximum Observed Plasma Concentration (Tmax) of Relatlimab | Up to 123 Weeks |
Secondary
| Measure | Time frame |
|---|---|
| Disease Control Rate (DCR) per RECIST v1.1 by Investigator | Up to 123 Weeks |
| Duration of Response (DOR) per RECIST v1.1 by Investigator | Up to 123 Weeks |
| Best Overall Response (BOR) per RECIST v1.1 by Investigator | Up to 123 Weeks |
| Ctrough of Nivolumab | Up to 123 Weeks |
| Observed Serum Concentration at End of Infusion (Ceoi) of Nivolumab | Up to 123 Weeks |
| Percentage of Participants Positive for Anti-drug Antibodies (ADAs) to Relatlimab | Up to 123 Weeks |
| Percentage of Participants Positive for ADAs to Nivolumab | Up to 123 Weeks |
| Objective Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 by Investigator | Up to 123 Weeks |
Countries
China
Outcome results
None listed