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

Bristol-Myers Squibb (BMS)

Status and phase: Terminated; Phase 2; Phase 1

Conditions: Advanced Cancer

Treatments: Drug: BMS-986148; Biological: Nivolumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT02341625

2014-002485-70 (EudraCT Number)

CA008-002

Details and patient eligibility

About

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.

Enrollment: 126 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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126 participants in 4 patient groups

Part 1: Ascending dose of BMS-986148

Experimental group

Description:

BMS-986148 Intravenous injection at increasing doses on specific days until the maximum tolerated dose is reached. Five cancers will be studied in this part: mesothelioma, pancreatic, ovarian, gastric, and non-small cell lung cancer. Alternate dose and schedules may be explored.

Treatment:

Drug: BMS-986148

Part 2: Expansion dose of BMS-986148

Experimental group

Description:

BMS-986148 Intravenous injection of Maximum tolerated dose (MTD) on specific days. Five cancers will be studied in this part: mesothelioma, pancreatic, ovarian, gastric, and non-small cell lung cancer.

Treatment:

Drug: BMS-986148

Part 3A: Ascending dose of BMS-986148

Experimental group

Description:

Set dose of nivolumab and BMS-986148 intravenous injection at increasing doses on specific days until the maximum tolerated dose is reached. Five cancers will be studied in this part: mesothelioma, pancreatic, ovarian, gastric, and non-small cell lung cancer.

Treatment:

Drug: BMS-986148

Biological: Nivolumab

Part 3B: Expansion dose of BMS-986148

Experimental group

Description:

Set dose of nivolumab and BMS-986148 intravenous injection at or below maximum tolerated dose on specific days. Five cancers will be studied in this part: mesothelioma, pancreatic, ovarian, gastric, and non-small cell lung cancer.

Treatment:

Drug: BMS-986148

Biological: Nivolumab