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

Program Status

Active, not recruiting

Phase

Phase 1

Immunotherapy-centered Trial

No

Prior Immunotherapy Allowed

Yes

CRC-directed Trial

No

Drugs

Nivolumab, Relatlimab, Opdivo

Tags

MSS/ MMRp

Comments

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, Opdivo)

Location Location Status
Japan
Local Institution - 0001
Kashiwa-shi, Chiba 2778577
Active, not recruiting

Inclusion Criteria

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

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

NCT ID

NCT02966548

Date Trial Added

2016-11-17

Updated Date

2024-01-31