Clinical trial NCT05134948: A Study to Assess Relatlimab and Nivolumab Fixed-dose Combination in Chinese Participants With Advanced Solid Tumors
Official title: A Phase 1/2 Study of Relatlimab (Anti-LAG-3 Monoclonal Antibody) and Nivolumab (Anti-PD-1 Monoclonal Antibody) Fixed-dose Combination in Chinese Participants With Advanced Solid Tumors (RELATIVITY 059)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE1
PHASE2
Conditions: Advanced Solid Tumors
Keywords: BMS-986213
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2021-11-26
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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/exclusion criteria apply

Primary outcomes:
measure: Number of Participants with Adverse Events (AEs)
timeFrame: Approximately 3 years
measure: Number of Participants with Immune-mediated Adverse Events (IMAEs)
timeFrame: Approximately 3 years
measure: Number of Participants with Serious Adverse Events (SAEs)
timeFrame: Approximately 3 years
measure: Number of Deaths
timeFrame: Approximately 3 years
measure: Number of Participants with AEs Leading to Discontinuation
timeFrame: Approximately 3 years
measure: Number of Participants with Laboratory Abnormalities
timeFrame: Approximately 3 years
measure: Maximum Observed Plasma Concentration (Cmax) of Relatlimab
timeFrame: Approximately 3 years
measure: Time of Maximum Observed Plasma Concentration (Tmax) of Relatlimab
timeFrame: Approximately 3 years
measure: Trough Observed Plasma Concentration (Ctrough) of Relatlimab
timeFrame: Approximately 3 years
measure: Concentration of Relatlimab at the end of a dosing interval (Ctau)
timeFrame: Approximately 3 years
measure: Average concentration of Relatlimab over a dosing interval (Cavg(TAU))
timeFrame: Approximately 3 years
measure: Area under the concentration-time curve in one dosing interval (AUC(TAU)) of Relatlimab
timeFrame: Approximately 3 years
measure: Total Body Clearance (CLT) of Relatlimab
timeFrame: Approximately 3 years
measure: Observed Concentration of Relatlimab at End of Infusion (Ceoi)
timeFrame: Approximately 3 years
Secondary outcomes:
measure: Objective Response Rate (ORR) by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 by Investigator
timeFrame: Approximately 3 years
measure: Disease Control Rate (DCR) by RECIST v1.1 by Investigator
timeFrame: Approximately 3 years
measure: Duration of Response (DOR) by RECIST v1.1 by Investigator
timeFrame: Approximately 3 years
measure: Best Overall Response (BOR) by RECIST v1.1 by Investigator
timeFrame: Approximately 3 years
measure: Ctrough of Nivolumab
timeFrame: Approximately 3 years
measure: Ceoi of Nivolumab
timeFrame: Approximately 3 years
measure: Number of Anti-drug Antibodies (ADAs) to Relatlimab
timeFrame: Approximately 3 years
measure: Number of ADAs to Nivolumab
timeFrame: Approximately 3 years
Other outcomes:
Locations:
city: Beijing
country: China
facility: Local Institution - 0001
state: Beijing
city: Fuzhou
country: China
facility: Local Institution - 0002
state: Fujian
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: