A Study of BMS-986488 as Monotherapy and Combination Therapy in Participants With Advanced Malignant Tumors
NCT ID: NCT06764771
Last Updated: 2025-11-13
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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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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Keywords
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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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John Theurer Cancer Center at Hackensack University Medical Center
Hackensack, New Jersey, United States
Lehigh Valley Health Network
Allentown, Pennsylvania, United States
The West Clinic, PLLC dba West Cancer Center
Germantown, Tennessee, United States
Local Institution - 0025
Dallas, Texas, United States
Royal Brisbane and Women's Hospital
Brisbane, Queensland, Australia
BC Cancer Vancouver
Vancouver, British Columbia, Canada
Local Institution - 0015
Montreal, Quebec, Canada
Centre intégré de cancérologie du CHU de Québec Université Laval, Hôpital de l'Enfant-Jésus
Québec, Quebec, 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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Martin Gutierrez, Site 0021
Role: primary
Suresh Nair, Site 0020
Role: primary
Daniel Vaena, Site 0024
Role: primary
Chun Loo Gan, Site 0031
Role: primary
Christian Kollmannsberger, Site 0032
Role: primary
Site 0015
Role: primary
Antoine Morin Coulombe, Site 0016
Role: primary
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