Clinical trial NCT05498480: Study of Relatlimab in Combination With Nivolumab in Chinese Participants
Official title: A Phase 1 Study of Relatlimab (Anti-LAG-3 Monoclonal Antibody) in Combination With Nivolumab (Anti-PD-1 Monoclonal Antibody) in Chinese Participants With Advanced Solid Tumors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Advanced Solid Tumors
Keywords: Advanced Solid Tumors
Relatlimab
Nivolumab
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2022-08-12
Enrollment: 6
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 evaluate the safety and drug levels of relatlimab combined with nivolumab in Chinese participants with advanced solid tumors.


Eligibility criteria: 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/exclusion criteria apply

Primary outcomes:
measure: Number of Participants with Adverse Events (AEs)
timeFrame: Up to 123 Weeks
measure: Number of Participants with Immune-mediated Adverse Events (IMAEs)
timeFrame: Up to 123 Weeks
measure: Number of Participants with Serious Adverse Events (SAEs)
timeFrame: Up to 123 Weeks
measure: Number of Deaths
timeFrame: Up to 123 Weeks
measure: Number of Participants with AEs Leading to Discontinuation
timeFrame: Up to 123 Weeks
measure: Number of Participants with Dose-Limiting Toxicities (DLTs)
timeFrame: Up to 123 Weeks
measure: Number of Participants with Clinical Laboratory Abnormalities
timeFrame: Up to 123 Weeks
measure: Maximum Observed Plasma Concentration (Cmax) of Relatlimab
timeFrame: Up to 123 Weeks
measure: Time of Maximum Observed Plasma Concentration (Tmax) of Relatlimab
timeFrame: Up to 123 Weeks
measure: Trough-observed serum concentration (Ctrough) of Relatlimab
timeFrame: Up to 123 Weeks
Secondary outcomes:
measure: Objective Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 by Investigator
timeFrame: Up to 123 Weeks
measure: Disease Control Rate (DCR) per RECIST v1.1 by Investigator
timeFrame: Up to 123 Weeks
measure: Duration of Response (DOR) per RECIST v1.1 by Investigator
timeFrame: Up to 123 Weeks
measure: Best Overall Response (BOR) per RECIST v1.1 by Investigator
timeFrame: Up to 123 Weeks
measure: Ctrough of Nivolumab
timeFrame: Up to 123 Weeks
measure: Observed Serum Concentration at End of Infusion (Ceoi) of Nivolumab
timeFrame: Up to 123 Weeks
measure: Percentage of Participants Positive for Anti-drug Antibodies (ADAs) to Relatlimab
timeFrame: Up to 123 Weeks
measure: Percentage of Participants Positive for ADAs to Nivolumab
timeFrame: Up to 123 Weeks
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Fudan University Shanghai Cancer Center
state: Shanghai
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: