Brief Title: 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

PRIMARY OUTCOMES

Primary Outcome 1 - Measure: Proportion of subjects with Adverse Events (AEs)

Primary Outcome 1 - Timeframe: Approximately Up to 3 years

Primary Outcome 2 - Measure: Proportion of subjects with Serious Adverse Events (SAEs)

Primary Outcome 2 - Timeframe: Approximately Up to 3 years

Primary Outcome 3 - Measure: Proportion of Deaths

Primary Outcome 3 - Timeframe: Approximately Up to 3 years

Primary Outcome 4 - Measure: Proportion of subjects with laboratory abnormalities

Primary Outcome 4 - Timeframe: Approximately Up to 3 years

Primary Outcome 5 - Measure: Objective response rate (ORR)

Primary Outcome 5 - Timeframe: Approximately 3 years

Primary Outcome 6 - Measure: Disease control rate (DCR)

Primary Outcome 6 - Timeframe: Approximately 3 years

Primary Outcome 7 - Measure: Duration of response (DOR)

Primary Outcome 7 - Timeframe: Approximately 3 years

Primary Outcome 8 - Measure: Proportion of participants with AEs meeting acute safety criteria

Primary Outcome 8 - Timeframe: Approximately 3 years

Primary Outcome 9 - Measure: Proportion of subjects with AEs leading to discontinuation of treatment

Primary Outcome 9 - Timeframe: Approximately up to 3 years

CONDITION

• Neoplasms by Site

ELIGIBILITY

Gender: All

Minimum Age: N/A

Maximum Age: 12 Years

Healthy Volunteers: No

OFFICIAL INFORMATION

Name: Bristol-Myers Squibb

Role: Study Director

Affiliation: Bristol-Myers Squibb

Overall Contact

Name: Bristol-Myers Squibb

Phone: N/A

Email: Clinical.Trials@bms.com

LOCATION