A Study of BMS-986148 in Patients With Select Advanced Solid Tumors
NCT ID: NCT02341625
Last Updated: 2022-08-18
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE1/PHASE2
126 participants
INTERVENTIONAL
2015-06-19
2020-05-07
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Part 1: Ascending dose of BMS-986148
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.
BMS-986148
Part 2: Expansion dose of BMS-986148
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.
BMS-986148
Part 3A: Ascending dose of BMS-986148
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.
BMS-986148
Nivolumab
Part 3B: Expansion dose of BMS-986148
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.
BMS-986148
Nivolumab
Interventions
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BMS-986148
Nivolumab
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Bristol-Myers Squibb
INDUSTRY
Responsible Party
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Principal Investigators
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Bristol-Myers Squibb
Role: STUDY_DIRECTOR
Bristol-Myers Squibb
Locations
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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
Countries
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References
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Rottey S, Clarke J, Aung K, Machiels JP, Markman B, Heinhuis KM, Millward M, Lolkema M, Patel SP, de Souza P, Duca M, Curigliano G, Santoro A, Koyama T, Brown M, Vezina H, He C, Chu QS. Phase I/IIa Trial of BMS-986148, an Anti-mesothelin Antibody-drug Conjugate, Alone or in Combination with Nivolumab in Patients with Advanced Solid Tumors. Clin Cancer Res. 2022 Jan 1;28(1):95-105. doi: 10.1158/1078-0432.CCR-21-1181. Epub 2021 Oct 6.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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BMS Clinical Trial Information
BMS Clinical Trial Patient Recruiting
Investigator Inquiry Form
FDA Safety Alerts and Recalls
Other Identifiers
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2014-002485-70
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
CA008-002
Identifier Type: -
Identifier Source: org_study_id
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