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

• Status: Active, not recruiting
• Trial end date: 2022-09-09
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Bristol-Myers Squibb
• Collaborator: Ono Pharmaceutical Co. Ltd
• Treatments: Antibodies, Monoclonal; Nivolumab

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:

• 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