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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05498480
Other study ID # CA224-111
Secondary ID
Status Completed
Phase Phase 1
First received
Last updated
Start date July 27, 2022
Est. completion date January 18, 2024

Study information

Verified date February 2024
Source Bristol-Myers Squibb
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 6
Est. completion date January 18, 2024
Est. primary completion date January 18, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Biological:
Relatlimab
Specified dose on specified days
Nivolumab
Specified dose on specified days

Locations

Country Name City State
China Fudan University Shanghai Cancer Center Shanghai Shanghai

Sponsors (1)

Lead Sponsor Collaborator
Bristol-Myers Squibb

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Number of Participants with Adverse Events (AEs) Up to 123 Weeks
Primary Number of Participants with Immune-mediated Adverse Events (IMAEs) Up to 123 Weeks
Primary Number of Participants with Serious Adverse Events (SAEs) Up to 123 Weeks
Primary Number of Deaths Up to 123 Weeks
Primary Number of Participants with AEs Leading to Discontinuation Up to 123 Weeks
Primary Number of Participants with Dose-Limiting Toxicities (DLTs) Up to 123 Weeks
Primary Number of Participants with Clinical Laboratory Abnormalities Up to 123 Weeks
Primary Maximum Observed Plasma Concentration (Cmax) of Relatlimab Up to 123 Weeks
Primary Time of Maximum Observed Plasma Concentration (Tmax) of Relatlimab Up to 123 Weeks
Primary Trough-observed serum concentration (Ctrough) of Relatlimab Up to 123 Weeks
Secondary Objective Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 by Investigator Up to 123 Weeks
Secondary Disease Control Rate (DCR) per RECIST v1.1 by Investigator Up to 123 Weeks
Secondary Duration of Response (DOR) per RECIST v1.1 by Investigator Up to 123 Weeks
Secondary Best Overall Response (BOR) per RECIST v1.1 by Investigator Up to 123 Weeks
Secondary Ctrough of Nivolumab Up to 123 Weeks
Secondary Observed Serum Concentration at End of Infusion (Ceoi) of Nivolumab Up to 123 Weeks
Secondary Percentage of Participants Positive for Anti-drug Antibodies (ADAs) to Relatlimab Up to 123 Weeks
Secondary Percentage of Participants Positive for ADAs to Nivolumab Up to 123 Weeks
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