Advanced Solid Tumors
Conditions
Keywords
BMS-986213
Brief summary
The purpose of this study is to assess the safety, drug levels, immunogenicity and preliminary efficacy of BMS-986213 (nivolumab-relatlimab fixed-dose combination) in Chinese participants with advanced solid tumors.
Interventions
DRUGBMS-986213
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
* Presence of at least one lesion with measurable disease as defined by RECIST v1.1 criteria for response assessment * Participants must have received, and then progressed, or been intolerant to at least one standard treatment regimen in the advanced or metastatic setting, if such a therapy exists * ECOG status of 0 or 1 * Life expectancy of ≥ 12 weeks at the time of informed consent per Investigator assessment
Exclusion criteria
* Participants with history of severe and/or life-threatening toxicity related to prior immune therapy (eg, anti-CTLA-4 or anti-PD-1/PD-L1 treatment or any other antibody or drug specifically targeting T-cell co-stimulation or immune checkpoint pathways) * Participants with an active, known or suspected autoimmune disease * Participants with primary CNS tumors Other protocol-defined inclusion/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Observed Concentration of Relatlimab at End of Infusion (Ceoi) | Approximately 3 years |
| Number of Participants with Laboratory Abnormalities | Approximately 3 years |
| Maximum Observed Plasma Concentration (Cmax) of Relatlimab | Approximately 3 years |
| Time of Maximum Observed Plasma Concentration (Tmax) of Relatlimab | Approximately 3 years |
| Trough Observed Plasma Concentration (Ctrough) of Relatlimab | Approximately 3 years |
| Concentration of Relatlimab at the end of a dosing interval (Ctau) | Approximately 3 years |
| Average concentration of Relatlimab over a dosing interval (Cavg(TAU)) | Approximately 3 years |
| Area under the concentration-time curve in one dosing interval (AUC(TAU)) of Relatlimab | Approximately 3 years |
| Total Body Clearance (CLT) of Relatlimab | Approximately 3 years |
| Number of Participants with Adverse Events (AEs) | Approximately 3 years |
| Number of Participants with Immune-mediated Adverse Events (IMAEs) | Approximately 3 years |
| Number of Participants with Serious Adverse Events (SAEs) | Approximately 3 years |
| Number of Deaths | Approximately 3 years |
| Number of Participants with AEs Leading to Discontinuation | Approximately 3 years |
Secondary
| Measure | Time frame |
|---|---|
| Disease Control Rate (DCR) by RECIST v1.1 by Investigator | Approximately 3 years |
| Duration of Response (DOR) by RECIST v1.1 by Investigator | Approximately 3 years |
| Best Overall Response (BOR) by RECIST v1.1 by Investigator | Approximately 3 years |
| Ctrough of Nivolumab | Approximately 3 years |
| Ceoi of Nivolumab | Approximately 3 years |
| Number of Anti-drug Antibodies (ADAs) to Relatlimab | Approximately 3 years |
| Number of ADAs to Nivolumab | Approximately 3 years |
| Objective Response Rate (ORR) by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 by Investigator | Approximately 3 years |
Countries
China
Outcome results
None listed