A Study to Assess Relatlimab and Nivolumab Fixed-dose Combination in Chinese Participants With Advanced Solid Tumors

Launched by BRISTOL-MYERS SQUIBB · Nov 16, 2021

Keywords

ClinConnect Summary

This clinical trial is looking at a new combination treatment called BMS-986213, which combines two drugs, relatlimab and nivolumab, to see how safe it is and how well it works in people with advanced solid tumors. The study is specifically for Chinese participants who have already tried at least one standard treatment for their cancer but either did not improve or could not tolerate that treatment. To be eligible, participants should have measurable cancer lesions and a good performance status, meaning they are relatively healthy and can carry out daily activities.

Participants in this trial can expect to receive the fixed-dose combination treatment and will be monitored closely for any side effects and how their cancer responds. It's important to note that individuals with certain conditions, like severe reactions to previous immune therapies or active autoimmune diseases, cannot participate. The trial is currently active, meaning they are still collecting data but are not recruiting new participants at this time. This study aims to gather information that could help improve cancer treatment options in the future.

Gender

ALL

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