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

Stopped early · Phase 1/Phase 2

Conditions studied: Advanced Cancer

In brief

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.

Key facts

Study ID

NCT02341625

Run by

Bristol-Myers Squibb

People needed

126

Starts

2015-06-19

Expected to finish

2020-05-07

Last updated by the study team

2022-08-18

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Moores Cancer Center — La Jolla, California, United States
• Duke University Medical Center — Durham, North Carolina, United States
• Local Institution - 0013 — Liverpool, New South Wales, Australia
• Local Institution - 0014 — Adelaide, South Australia, Australia
• Local Institution - 0004 — Clayton, Victoria, Australia
• Local Institution - 0015 — Nedlands, Western Australia, Australia
• Local Institution - 0008 — Ghent, Oost-Vlaanderen, Belgium
• Local Institution - 0009 — Brussels, Belgium
• Local Institution - 0002 — Edmonton, Alberta, Canada
• Local Institution - 0003 — Toronto, Ontario, Canada
• Local Institution - 0017 — Milan, Lombardy, Italy
• Local Institution - 0018 — Milan, Italy
• Local Institution - 0016 — Rozzano (milano), Italy
• Local Institution - 0010 — Amsterdam, Netherlands
• Local Institution - 0011 — Rotterdam, Netherlands
• Local Institution - 0007 — Southampton, Hampshire, United Kingdom
• Local Institution - 0006 — Glasgow, Lanarkshire, United Kingdom

Full record on ClinicalTrials.gov

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