Brief Title: 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 participants with Adverse Events (AEs)

Primary Outcome 1 - Timeframe: Approximately Up to 3 years

Primary Outcome 2 - Measure: Proportion of participants 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 participants with laboratory abnormalities in blood

Primary Outcome 4 - Timeframe: Approximately Up to 3 years

Primary Outcome 5 - Measure: Proportion of participants with laboratory abnormalities in blood serum

Primary Outcome 5 - Timeframe: Approximately Up to 3 years

Primary Outcome 6 - Measure: Proportion of participants with laboratory abnormalities in urine

Primary Outcome 6 - Timeframe: Approximately Up to 3 years

Primary Outcome 7 - Measure: Objective response rate (ORR)

Primary Outcome 7 - Timeframe: Approximately 3 years

Primary Outcome 8 - Measure: Disease control rate (DCR)

Primary Outcome 8 - Timeframe: Approximately 3 years

Primary Outcome 9 - Measure: Duration of response (DOR)

Primary Outcome 9 - Timeframe: Approximately 3 years

Primary Outcome 10 - Measure: Number of AEs in the Broad Scope MedDRA Anaphylactic Reaction SMQ

Primary Outcome 10 - Timeframe: Approximately 3 years

Primary Outcome 11 - Measure: Proportion of participants with AEs leading to discontinuation of treatment

Primary Outcome 11 - Timeframe: Approximately up to 3 years

CONDITION

• Neoplasms by Site

ELIGIBILITY

Inclusion Criteria:
* For Dose escalation: subjects with cervical, ovarian, bladder and colorectal cancer (CRC), head and neck, gastric and hepatocellular cancer naive to immuno-oncology agents; 1st line melanoma and 1st line/2nd line NSCLC; Renal Cell Carcinoma naive to IO; NSCLC progressing while on or after therapy with anti-PD1/anti-PDL-1 and melanoma subjects progressed while-on or after treatment with anti-PD1 or anti-PDL1 with or without anti-CTLA-4.

- * For Dose Expansion: all of the above in escalation except for cervical, ovarian, and CRC

- * Progressed, or been intolerant to, at least one standard treatment regimen, except for participants in 1st line cohorts.

- * ECOG performance status between 0 and 2

- * At least 1 lesion with measurable disease at baseline

- * Availability of an existing tumor biopsy sample (and consent to allow pre-treatment tumor biopsy)
Exclusion Criteria:
* Primary central nervous system (CNS) tumors or solid tumors with CNS metastases as the only site of active disease

- * Autoimmune disease

- * Encephalitis, meningitis, or uncontrolled seizures in the year prior to informed consent

- * Uncontrolled CNS metastases
Other protocol defined inclusion/exclusion criteria could apply

Gender: All

Minimum Age: 12 Years

Maximum Age: N/A

Healthy Volunteers: No

OFFICIAL INFORMATION

Name: Bristol-Myers Squibb

Role: Study Director

Affiliation: Bristol-Myers Squibb

Overall Contact

Name: N/A

Phone: N/A

Email: N/A

LOCATION