A Study of BMS-986148 in Patients With Select Advanced Solid Tumors

• Status: Active, not recruiting
• Trial end date: 2022-08-29
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine the safety, tolerability, pharmacokinetics, immunogenicity, antitumor activity and pharmacodynamics of BMS-986148 administered alone and in combination with nivolumab in patients with mesothelioma, non-small cell lung cancer, ovarian cancer, pancreatic cancer and gastric cancer.

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

Details

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

Criteria

For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

• Must have pancreatic, ovarian, gastric, non-small cell cancer or mesothelioma. For dose expansion, must have tumor that is positive for mesothelin

• Expected to have life expectancy of at least 3 months

• Men and women 18 years old or older (or local age of majority)

• Must have measurable tumor per Response Evaluation Criteria In Solid Tumors (RECIST) or modified RECIST for malignant pleural mesothelioma

• ECOG of 0 to 1

Exclusion Criteria:

• Cancer metastases in the brain

• Moderate eye disorders

• Active infection or past hepatitis B or C infection

• Major surgery less than 1 month before the start of the study

• Uncontrolled heart disease

• Impaired liver or bone marrow function

• History of allergy to mesothelin-directed antibodies, tubulysin, monoclonal antibodies, nivolumab or related compounds