An Investigational Immuno-therapy Study of Experimental Medication BMS-986156, Given by Itself or in Combination With Nivolumab in Patients With Solid Cancers or Cancers That Have Spread.
NCT ID: NCT02598960
Last Updated: 2023-03-06
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE1/PHASE2
295 participants
INTERVENTIONAL
2015-10-14
2019-12-16
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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BMS-986156: Dose Escalation
BMS-986156
BMS-986156 + nivolumab (nivo): Dose Escalation
BMS-986156
Nivolumab
BMS-986156: Dose Expansion
BMS-986156
BMS-986156 + nivolumab (nivo): Dose Expansion
BMS-986156
Nivolumab
BMS986156 + Nivo: Cohort Expansion
BMS-986156
Nivolumab
Interventions
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BMS-986156
Nivolumab
Eligibility Criteria
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Inclusion Criteria
* Subjects with any previously treated advanced (metastatic or refractory) solid tumor
* For Cohort Expansion:
* Subjects must have a previously treated advanced solid tumor to be eligible
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
* Willing and able to provide pre-treatment and on-treatment fresh tumor biopsy
* Women of child-bearing potential and men must use an acceptable method of contraception during treatment and for 23 weeks after treatment for women and 31 weeks for men
Exclusion Criteria
* Other concomitant malignancies (with some exceptions per protocol)
* Active, known or suspected autoimmune disease
* Uncontrolled or significant cardiovascular disease
* History of active or chronic hepatitis (e.g. Hep B or C)
* Impaired liver or bone marrow function
* Major surgery less than 1 month before start of the study
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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University Of Alabama At Birmingham
Birmingham, Alabama, United States
UCSD Moores Cancer Center
La Jolla, California, United States
Emory University
Atlanta, Georgia, United States
The Ohio State University
Columbus, Ohio, United States
Providence Portland Medical Center
Portland, Oregon, United States
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, United States
The West Clinic, P.C.
Germantown, Tennessee, United States
Liverpool Cancer Therapy Center
Liverpool, New South Wales, Australia
Local Institution
Westmead, New South Wales, Australia
Princess Alexandra Hospital
Brisbane, Queensland, Australia
Linear Clinical Research Ltd
Nedlands, Western Australia, Australia
Local Institution - 0012
Ghent, , Belgium
Local Institution
Edmonton, Alberta, Canada
Local Institution
Toronto, Ontario, Canada
Local Institution
Paris, , France
Institut Claudius Regaud
Toulouse, , France
Institut Gustave Roussy
Vlllejuif, , France
Local Institution
Bonn, , Germany
Local Institution
Freiburg im Breisgau, , Germany
Local Institution
Würzburg, , Germany
Local Institution - 0015
Milan, Lombardy, Italy
Local Institution - 0014
Milan, , Italy
Local Institution
Amsterdam, , Netherlands
Local Institution
Madrid, , Spain
Local Institution
Madrid, , Spain
Cantonal Hospital St. Gallen
Sankt Gallen, , Switzerland
Local Institution
Zurich, , Switzerland
Countries
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References
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Wang R, Baxi V, Li Z, Locke D, Hedvat C, Sun Y, Walsh AM, Shao X, Basavanhally T, Greenawalt DM, Patah P, Novosiadly R. Pharmacodynamic activity of BMS-986156, a glucocorticoid-induced TNF receptor-related protein agonist, alone or in combination with nivolumab in patients with advanced solid tumors. ESMO Open. 2023 Apr;8(2):100784. doi: 10.1016/j.esmoop.2023.100784. Epub 2023 Feb 28.
Heinhuis KM, Carlino M, Joerger M, Di Nicola M, Meniawy T, Rottey S, Moreno V, Gazzah A, Delord JP, Paz-Ares L, Britschgi C, Schilder RJ, O'Byrne K, Curigliano G, Romano E, Patah P, Wang R, Liu Y, Bajaj G, Siu LL. Safety, Tolerability, and Potential Clinical Activity of a Glucocorticoid-Induced TNF Receptor-Related Protein Agonist Alone or in Combination With Nivolumab for Patients With Advanced Solid Tumors: A Phase 1/2a Dose-Escalation and Cohort-Expansion Clinical Trial. JAMA Oncol. 2020 Jan 1;6(1):100-107. doi: 10.1001/jamaoncol.2019.3848.
Provided Documents
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Document Type: Study Protocol and 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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2015-002505-11
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
CA009-002
Identifier Type: -
Identifier Source: org_study_id
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