An Investigational Immunotherapy Study of BMS-986258 Alone and in Combination With Nivolumab in Participants With Solid Cancers That Are Advanced or Have Spread
NCT ID: NCT03446040
Last Updated: 2025-09-18
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE1/PHASE2
92 participants
INTERVENTIONAL
2018-03-08
2024-08-29
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 A Dose Escalation: BMS-986258
BMS-986258
Specified dose on specified days
Part A1: BMS-986258 + Recombinant human hyaluronidase PH20 (rHuPH20)
BMS-986258
Specified dose on specified days
rHuPH20
Specified dose on specified days
Part B Dose Escalation: BMS-986258 + nivolumab
BMS-986258
Specified dose on specified days
Nivolumab
Specified dose on specified days
Part C Cohort Expansion: BMS-986258 + nivolumab
BMS-986258
Specified dose on specified days
Nivolumab
Specified dose on specified days
Interventions
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BMS-986258
Specified dose on specified days
Nivolumab
Specified dose on specified days
rHuPH20
Specified dose on specified days
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Eastern Cooperative Oncology Group Performance Status of 0 or 1
* Participants must have received, and then progressed, relapsed, or been intolerant to, at least 1 standard treatment regimen in the advanced or metastatic setting according to solid tumor histologies
* Women must agree to follow specific methods of contraception, if applicable
Exclusion Criteria
* Cytotoxic agents, unless at least 4 weeks have elapsed from last dose of prior anti-cancer therapy and initiation of study therapy
* Other active malignancy requiring concurrent intervention
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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Local Institution - 0004
Los Angeles, California, United States
Local Institution - 0006
Los Angeles, California, United States
Local Institution - 0007
Aurora, Colorado, United States
University Of Iowa Hospitals And Clinics
Iowa City, Iowa, United States
Local Institution - 0018
Ann Arbor, Michigan, United States
Local Institution - 0010
Grand Rapids, Michigan, United States
Local Institution - 0012
Lebanon, New Hampshire, United States
Local Institution - 0016
Cincinnati, Ohio, United States
Local Institution - 0005
Pittsburgh, Pennsylvania, United States
Local Institution - 0002
Germantown, Tennessee, United States
Local Institution - 0013
Westmead, New South Wales, Australia
Local Institution - 0015
Melbourne, Victoria, Australia
Local Institution - 0014
Edmonton, Alberta, Canada
Local Institution - 0019
Vancouver, British Columbia, Canada
Local Institution - 0009
Kobe, Hyōgo, Japan
Local Institution - 0008
Chuo-ku, Tokyo, Japan
Countries
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References
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El Halabi L, Adam J, Gravelle P, Marty V, Danu A, Lazarovici J, Ribrag V, Bosq J, Camara-Clayette V, Laurent C, Ghez D. Expression of the Immune Checkpoint Regulators LAG-3 and TIM-3 in Classical Hodgkin Lymphoma. Clin Lymphoma Myeloma Leuk. 2021 Apr;21(4):257-266.e3. doi: 10.1016/j.clml.2020.11.009. Epub 2020 Nov 12.
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
Other Identifiers
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2019-000442-35
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
CA031-002
Identifier Type: -
Identifier Source: org_study_id
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