A Study of BMS-986488 as Monotherapy and Combination Therapy in Participants With Advanced Malignant Tumors

June 2, 2026 updated by: Bristol-Myers Squibb

A Phase 1/1b Open-label Study of BMS-986488 as Monotherapy and Combination Therapy in Participants With Advanced Malignant Tumors

This purpose of this study is to determine if experimental treatment with BMS-986488, alone, or in combinations is safe, tolerable, and has anti-cancer activity in patients with advanced malignant tumors.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

437

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: First line of the email MUST contain NCT # and Site #.

Study Contact Backup

  • Name: BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
  • Phone Number: 855-907-3286
  • Email: Clinical.Trials@bms.com

Study Locations

  • Australia
    • Queensland
      • Brisbane, Queensland, Australia, 4029
        • Active, not recruiting
        • Local Institution - 0031
  • Canada
    • British Columbia
      • Vancouver, British Columbia, Canada, V5Z 4E6
        • Active, not recruiting
        • Local Institution - 0032
    • Quebec
      • Montreal, Quebec, Canada, H2X 0A9
        • Not yet recruiting
        • Local Institution - 0015
        • Contact:
          • Site 0015
      • Québec, Quebec, Canada, G1J 1Z4
        • Active, not recruiting
        • Local Institution - 0016
  • United States
    • New Jersey
      • Hackensack, New Jersey, United States, 07601
        • Recruiting
        • John Theurer Cancer Center at Hackensack University Medical Center
        • Contact:
          • Martin Gutierrez, Site 0021
          • Phone Number: 551-996-5863
    • Pennsylvania
      • Allentown, Pennsylvania, United States, 18103
        • Active, not recruiting
        • Local Institution - 0020
    • Tennessee
      • Germantown, Tennessee, United States, 38138
        • Recruiting
        • The West Clinic, PLLC dba West Cancer Center
        • Contact:
          • Daniel Vaena, Site 0024
          • Phone Number: 901-598-1454
    • Texas
      • Dallas, Texas, United States, 75390
        • Withdrawn
        • Local Institution - 0025

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Participant must be ≥ 18 years of age.
  • 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:

  • Untreated central nervous system (CNS) metastases.
  • 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).

- Other protocol-defined inclusion/exclusion criteria apply.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Part 1A: BMS-986488 Monotherapy
Drug: BMS-986488
Specified dose on specified days
Experimental: Part 1B: BMS-986488 + Adagrasib
Drug: Adagrasib
Specified dose on specified days
Other Names:
  • KRAZATI
  • MRTX849
  • BMS-986503
Drug: BMS-986488
Specified dose on specified days
Experimental: Part 1C: BMS-986488 + Adagrasib + Cetuximab
Drug: Cetuximab
Specified dose on specified days
Other Names:
  • ERBITUX
Drug: Adagrasib
Specified dose on specified days
Other Names:
  • KRAZATI
  • MRTX849
  • BMS-986503
Drug: BMS-986488
Specified dose on specified days
Experimental: Part 1D: BMS-986488 + Nivolumab
Drug: Nivolumab
Specified dose on specified days
Other Names:
  • BMS-936558
  • OPDIVO
Drug: BMS-986488
Specified dose on specified days
Experimental: Part 2A: BMS-986488 Monotherapy
Drug: BMS-986488
Specified dose on specified days
Experimental: Part 2B: BMS-986488 + Adagrasib
Drug: Adagrasib
Specified dose on specified days
Other Names:
  • KRAZATI
  • MRTX849
  • BMS-986503
Drug: BMS-986488
Specified dose on specified days
Experimental: Part 2C: BMS-986488 + Adagrasib + Cetuximab
Drug: Cetuximab
Specified dose on specified days
Other Names:
  • ERBITUX
Drug: Adagrasib
Specified dose on specified days
Other Names:
  • KRAZATI
  • MRTX849
  • BMS-986503
Drug: BMS-986488
Specified dose on specified days
Experimental: Part 2D: BMS-986488 + Nivolumab
Drug: Nivolumab
Specified dose on specified days
Other Names:
  • BMS-936558
  • OPDIVO
Drug: BMS-986488
Specified dose on specified days

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of participants with Adverse Events (AEs)
Time Frame: Until the end of the Safety Follow-up period (up to approximately 100 days after last dose)
Until the end of the Safety Follow-up period (up to approximately 100 days after last dose)
Number of participants with Serious AEs (SAEs)
Time Frame: Until the end of the Safety Follow-up period (up to approximately 100 days after last dose)
Until the end of the Safety Follow-up period (up to approximately 100 days after last dose)
Number of participants with AEs meeting protocol-defined Dose-Limiting Toxicity (DLT) criteria
Time Frame: From first dose of study treatment until end of cycle 1 (1 Cycle = 28 Days)
From first dose of study treatment until end of cycle 1 (1 Cycle = 28 Days)
Number of participants with AEs leading to discontinuation
Time Frame: Until the end of the Safety Follow-up period (up to approximately 100 days after last dose)
Until the end of the Safety Follow-up period (up to approximately 100 days after last dose)
Number of deaths
Time Frame: From time of informed consent up to 52 weeks after end of treatment visit
From time of informed consent up to 52 weeks after end of treatment visit

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Maximum observed plasma concentration (Cmax)
Time Frame: Until Cycle 4, Day 1 (1 Cycle = 28 Days)
Until Cycle 4, Day 1 (1 Cycle = 28 Days)
Time of maximum observed concentration (Tmax)
Time Frame: Until Cycle 4, Day 1 (1 Cycle = 28 Days)
Until Cycle 4, Day 1 (1 Cycle = 28 Days)
Area under the concentration-time curve in 1 dosing interval (AUC(TAU))
Time Frame: Until Cycle 4, Day 1 (1 Cycle = 28 Days)
Until Cycle 4, Day 1 (1 Cycle = 28 Days)
Objective response rate (ORR)
Time Frame: From time of informed consent up to 52 weeks after end of treatment visit
Defined as the proportion of participants who achieve a best overall response (BOR) of complete response (CR) or partial response (PR) assessed by the investigator using Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1)
From time of informed consent up to 52 weeks after end of treatment visit
Disease control rate (DCR)
Time Frame: From time of informed consent up to 52 weeks after end of treatment visit
Defined as the proportion of participants who achieve a best response of CR, PR, or stable disease (SD) assessed by the investigator using RECIST v1.1
From time of informed consent up to 52 weeks after end of treatment visit
Duration of response (DOR)
Time Frame: From time of informed consent up to 52 weeks after end of treatment visit
Defined as the time between the date of first documented response (CR or PR) to the date of the first documented disease progression as assessed by the investigator using RECIST v1.1 or death due to any cause, whichever occurs first
From time of informed consent up to 52 weeks after end of treatment visit

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bristol-Myers Squibb

Investigators

  • Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 25, 2025

Primary Completion (Estimated)

October 15, 2027

Study Completion (Estimated)

October 15, 2027

Study Registration Dates

First Submitted

January 3, 2025

First Submitted That Met QC Criteria

January 3, 2025

First Posted (Actual)

January 8, 2025

Study Record Updates

Last Update Posted (Actual)

June 3, 2026

Last Update Submitted That Met QC Criteria

June 2, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CA234-0001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria. Additional information regarding Bristol Myer Squibb's data sharing policy and process can be found at https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html

IPD Sharing Time Frame

See Plan Description

IPD Sharing Access Criteria

See Plan Description

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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