A Study of BMS-986488 as Monotherapy and Combination Therapy in Participants With Advanced Malignant Tumors
NCT ID: NCT06764771
Last Updated: 2025-12-17
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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ACTIVE_NOT_RECRUITING
PHASE1
437 participants
INTERVENTIONAL
2025-03-25
2027-10-15
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
SEQUENTIAL
TREATMENT
NONE
Study Groups
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Part 1A: BMS-986488 Monotherapy
BMS-986488
Specified dose on specified days
Part 1B: BMS-986488 + Adagrasib
BMS-986488
Specified dose on specified days
Adagrasib
Specified dose on specified days
Part 1C: BMS-986488 + Adagrasib + Cetuximab
BMS-986488
Specified dose on specified days
Adagrasib
Specified dose on specified days
Cetuximab
Specified dose on specified days
Part 1D: BMS-986488 + Nivolumab
BMS-986488
Specified dose on specified days
Nivolumab
Specified dose on specified days
Part 2A: BMS-986488 Monotherapy
BMS-986488
Specified dose on specified days
Part 2B: BMS-986488 + Adagrasib
BMS-986488
Specified dose on specified days
Adagrasib
Specified dose on specified days
Part 2C: BMS-986488 + Adagrasib + Cetuximab
BMS-986488
Specified dose on specified days
Adagrasib
Specified dose on specified days
Cetuximab
Specified dose on specified days
Part 2D: BMS-986488 + Nivolumab
BMS-986488
Specified dose on specified days
Nivolumab
Specified dose on specified days
Interventions
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BMS-986488
Specified dose on specified days
Adagrasib
Specified dose on specified days
Cetuximab
Specified dose on specified days
Nivolumab
Specified dose on specified days
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Histologically confirmed diagnosis of a locally advanced and unresectable or metastatic solid tumor malignancy with any of the following tumor types:.
* Part 1A: clear-cell renal cell carcinoma (ccRCC), clear-cell ovarian cancer (ccOC), non-small cell lung cancer (NSCLC), colorectal cancer (CRC), and pancreatic ductal adenocarcinoma (PDAC).
* Parts 2A, 1D, 2D: ccRCC.
i) Part 1B: solid tumors with KRAS G12C mutation.
ii) Part 2B: NSCLC with KRAS G12C mutation.
iii) Parts 1C, 2C: colorectal cancer (CRC) with KRAS G12C mutation.
* Participants must have an Eastern Cooperative Oncology Groups (ECOG) Performance Status of 0 or 1.
* Participants must have measurable disease per RECIST v1.1.
Exclusion Criteria
* Leptomeningeal metastasis (carcinomatous meningitis).
* Impaired cardiac function or clinically significant cardiac disease.
* For Parts 1B, 1C, 2B, 2C only (combination with adagrasib):.
i) History of pneumonitis or interstitial lung disease (ILD).
ii) 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 - 0021
Hackensack, New Jersey, United States
Local Institution - 0020
Allentown, Pennsylvania, United States
Local Institution - 0024
Germantown, Tennessee, United States
Local Institution - 0031
Brisbane, Queensland, Australia
Local Institution - 0032
Vancouver, British Columbia, Canada
Local Institution - 0015
Montreal, Quebec, Canada
Local Institution - 0016
Québec, Quebec, Canada
Countries
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Related Links
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BMS Clinical Trial Information
BMS Clinical Trial Patient Recruiting
Other Identifiers
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CA234-0001
Identifier Type: -
Identifier Source: org_study_id