An Investigational Immuno-therapy Study of BMS-986207 Given Alone and in Combination With Nivolumab or With Nivolumab and Ipilimumab in Solid Cancers That Are Advanced or Have Spread

• Status: Recruiting
• Trial end date: 2025-06-27
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate the safety and effectiveness of experimental medication BMS-986207 by itself, in combination with Nivolumab, and in combination with both nivolumab and ipilimumab in participants with solid cancers that are advanced or have spread.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

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

Criteria

For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

• Participant must consent for pretreatment and on treatment tumor biopsy samples

• For Part 1C tumor biopsies are optional

• Nonsmall cell lung cancer (NSCLC) without prior treatment in the advanced or metastatic setting (Part 2C)

• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

• Must have received, and progressed or been intolerant to, at least 1 standard treatment regimen in the advanced or metastatic setting (Part 1A, 1B and 1C)

• Measurable disease by computed tomography (CT) or magnetic resonance imaging (MRI) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 criteria; radiographic tumor assessment performed within 28 days before randomization

Exclusion Criteria:

• Primary central nervous system (CNS) disease, or tumors with CNS metastases as the only site of disease. Controlled brain metastases will be allowed to enroll

• Other active malignancy requiring concurrent intervention

• Uncontrolled/significant heart disease

• History of chronic hepatitis [except for hepatocellular carcinoma (HCC)]

• Active, known, or suspected autoimmune disease

Other protocol defined inclusion/exclusion criteria apply