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

Program Status

Active, not recruiting

Phase

Phase 1

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

2024-08-20