Safety Study of BMS-986016 With or Without Nivolumab in Patients With Advanced Solid Tumors

A Phase 1 Study of the Safety, Tolerability, and Efficacy of Anti-LAG-3 Monoclonal Antibody (BMS-986016) Administered Alone and in Combination With Anti-PD-1 Monoclonal Antibody (Nivolumab, BMS-936558) in Advanced Solid Tumors

This study will be used to determine the safety and tolerability of BMS-986016 administered alone and in combination with Nivolumab in subjects with advanced solid tumors.

For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

• Must have histologic or cytologic confirmation of an incurable solid malignancy that is advanced (metastatic and/or unresectable)
• Must have received, and then progressed or been intolerant to, standard treatment regimen in the advanced or metastatic setting, if such a therapy exists
• Presence of at least one lesion with measurable disease as defined by RECIST v1.1 criteria for response assessment
• Males and Females, ages 20 years or older, inclusive

Exclusion Criteria:

• Known or suspected CNS (central nervous system) metastases or with the CNS as the only site of active disease
• Other concomitant malignancies (with some exceptions per protocol)
• Any active autoimmune disease or history of known or suspected autoimmune disease
• History of uncontrolled or significant cardiovascular disease

Other protocol defined inclusion/exclusion criteria could apply