A Study to Evaluate the Safety, Tolerability, and Efficacy of BMS-986523 Alone and in Combination With Anti-Cancer Agents in Participants With Advanced Solid Malignancies
NCT ID: NCT07223047
Last Updated: 2025-10-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
PHASE1/PHASE2
252 participants
INTERVENTIONAL
2025-11-26
2028-10-13
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Arm A
BMS-986523
Specified dose on specified days
Arm B
BMS-986523
Specified dose on specified days
Arm C
BMS-986523
Specified dose on specified days
Arm D
BMS-986523
Specified dose on specified days
Pembrolizumab
Specified dose on specified days
Arm E
BMS-986523
Specified dose on specified days
Cetuximab
Specified dose on specified days
Arm F
BMS-986523
Specified dose on specified days
Gemcitabine
Specified dose on specified days
Nab-Paclitaxel
Specified dose on specified days
Interventions
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BMS-986523
Specified dose on specified days
Gemcitabine
Specified dose on specified days
Nab-Paclitaxel
Specified dose on specified days
Cetuximab
Specified dose on specified days
Pembrolizumab
Specified dose on specified days
Eligibility Criteria
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Inclusion Criteria
* Participants must, for Arm D, have a PD-L1 expression (≥50%).
* Participants must have previously received, be ineligible for, or decline (after having been provided adequate information to make an informed decision) the protocol defined standard of care (SoC) treatments.
Exclusion Criteria
* Participants must not have concurrent malignancy (present during screening) requiring treatment or history of prior malignancy active within 2 years prior to treatment.
* Participants must not have a history of, or any evidence of, interstitial lung disease or active, non-infectious pneumonitis. A history of radiation pneumonitis in the radiation field is permitted.
* Participants must not have a history of prior severe cutaneous adverse reactions (SCARs), including Stevens-Johnson Syndrome (SJS) and toxic epidermal necrolysis (TEN).
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 - 0001
San Antonio, Texas, United States
Local Institution - 0007
Salt Lake City, Utah, United States
Local Institution - 0011
Fairfax, Virginia, United States
Local Institution - 0002
Vancouver, British Columbia, Canada
Local Institution - 0010
Toronto, Ontario, Canada
Countries
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Central Contacts
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BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
Role: CONTACT
Phone: 8559073286
Email: [email protected]
First line of the email MUST contain the NCT# and Site#
Role: CONTACT
Facility Contacts
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Site 0001
Role: primary
Site 0007
Role: primary
Site 0011
Role: primary
Site 0002
Role: primary
Site 0010
Role: primary
Related Links
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BMS Clinical Trial Information
BMS Clinical Trial Patient Recruiting
Other Identifiers
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2025-523547-35
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
CA256-0001
Identifier Type: -
Identifier Source: org_study_id