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

Results pending

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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Recruitment Status

RECRUITING

Clinical Phase

PHASE1

Total Enrollment

437 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-03-25

Study Completion Date

2027-10-15

Brief Summary

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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.

Detailed Description

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Conditions

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Advanced Malignant Tumors

Keywords

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Colorectal Cancer CRC Renal Cell Carcinoma RCC Non-Small Cell Lung Cancer NSCLC Cancer Oncology Phase 1 Solid Tumor

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Part 1A: BMS-986488 Monotherapy

Group Type EXPERIMENTAL

BMS-986488

Intervention Type DRUG

Specified dose on specified days

Part 1B: BMS-986488 + Adagrasib

Group Type EXPERIMENTAL

BMS-986488

Intervention Type DRUG

Specified dose on specified days

Adagrasib

Intervention Type DRUG

Specified dose on specified days

Part 1C: BMS-986488 + Adagrasib + Cetuximab

Group Type EXPERIMENTAL

BMS-986488

Intervention Type DRUG

Specified dose on specified days

Adagrasib

Intervention Type DRUG

Specified dose on specified days

Cetuximab

Intervention Type DRUG

Specified dose on specified days

Part 1D: BMS-986488 + Nivolumab

Group Type EXPERIMENTAL

BMS-986488

Intervention Type DRUG

Specified dose on specified days

Nivolumab

Intervention Type DRUG

Specified dose on specified days

Part 2A: BMS-986488 Monotherapy

Group Type EXPERIMENTAL

BMS-986488

Intervention Type DRUG

Specified dose on specified days

Part 2B: BMS-986488 + Adagrasib

Group Type EXPERIMENTAL

BMS-986488

Intervention Type DRUG

Specified dose on specified days

Adagrasib

Intervention Type DRUG

Specified dose on specified days

Part 2C: BMS-986488 + Adagrasib + Cetuximab

Group Type EXPERIMENTAL

BMS-986488

Intervention Type DRUG

Specified dose on specified days

Adagrasib

Intervention Type DRUG

Specified dose on specified days

Cetuximab

Intervention Type DRUG

Specified dose on specified days

Part 2D: BMS-986488 + Nivolumab

Group Type EXPERIMENTAL

BMS-986488

Intervention Type DRUG

Specified dose on specified days

Nivolumab

Intervention Type DRUG

Specified dose on specified days

Interventions

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BMS-986488

Specified dose on specified days

Intervention Type DRUG

Adagrasib

Specified dose on specified days

Intervention Type DRUG

Cetuximab

Specified dose on specified days

Intervention Type DRUG

Nivolumab

Specified dose on specified days

Intervention Type DRUG

Other Intervention Names

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KRAZATI BMS-986503 MRTX849 ERBITUX OPDIVO BMS-936558

Eligibility Criteria

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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).
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bristol-Myers Squibb

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

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

Site Status RECRUITING

Lehigh Valley Health Network

Allentown, Pennsylvania, United States

Site Status RECRUITING

The West Clinic, PLLC dba West Cancer Center

Germantown, Tennessee, United States

Site Status RECRUITING

Local Institution - 0025

Dallas, Texas, United States

Site Status WITHDRAWN

Royal Brisbane and Women's Hospital

Brisbane, Queensland, Australia

Site Status RECRUITING

BC Cancer Vancouver

Vancouver, British Columbia, Canada

Site Status RECRUITING

Local Institution - 0015

Montreal, Quebec, Canada

Site Status NOT_YET_RECRUITING

Centre intégré de cancérologie du CHU de Québec Université Laval, Hôpital de l'Enfant-Jésus

Québec, Quebec, Canada

Site Status RECRUITING

Countries

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United States Australia Canada

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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Other Identifiers

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CA234-0001

Identifier Type: -

Identifier Source: org_study_id