A Study of BMS-986340 as Monotherapy and in Combination With Nivolumab in Participants With Advanced Solid Tumors

• Status: Recruiting
• Trial end date: 2025-08-23
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to assess the safety, tolerability, and recommended dose(s) of BMS-986340 as monotherapy and in combination with nivolumab in participants with advanced solid tumors. This study is a first-in-human (FIH) study of BMS-986340 in participants with advanced solid tumors.

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

Details

• Lead Sponsor: Bristol-Myers Squibb
• Treatments: Nivolumab

Criteria

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

Inclusion Criteria:

• Fresh pre-treatment and on-treatment tumor biopsy must be provided for biomarker analysis

• Measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 and at least 1 lesion accessible for biopsy

• Eastern Cooperative Oncology Group Performance Status of 0 or 1

• Radiographically documented progressive disease on or after the most recent therapy

• Received standard-of-care therapies, including an available programmed death (ligand)-1 inhibitor known to be effective in the tumor type for which they are being evaluated

• Parts 1A, 1B, and 2A: Advanced or metastatic non-small cell lung cancer, squamous cell carcinoma of head and neck, microsatellite stable colorectal cancer, gastric/ gastroesophageal junction adenocarcinoma, or cervical cancer, and have received, be refractory to, not be a candidate for, or be intolerant of existing therapies known to provide clinical benefit for the condition of the participant

Exclusion Criteria:

• Women who are pregnant or breastfeeding

• Primary central nervous system (CNS) malignancy

• Untreated CNS metastases

• Leptomeningeal metastases

• Concurrent malignancy requiring treatment or history of prior malignancy active within 2 years prior to the first dose of study treatment

• Active, known, or suspected autoimmune disease

• Condition requiring systemic treatment with either corticosteroids within 14 days or other immunosuppressive medications within 30 days of the first dose of study treatment

• Prior organ or tissue allograft

• Uncontrolled or significant cardiovascular disease

• Major surgery within 4 weeks of study drug administration

• History of or with active interstitial lung disease or pulmonary fibrosis

Other protocol-defined inclusion/exclusion criteria apply