A Solid Tumor Study for Long Term Treatment of Cancer Patients Who Participated in Adagrasib Studies

Solid Tumor Study for Long Term Treatment of Cancer Patients Who Have Participated in BMS Parent Studies Investigating Adagrasib (BMS-986503)

This is an open-label, solid tumor, continuation, rollover trial which enrolls participants from ongoing BMS parent studies that evaluated adagrasib (MRTX849, BMS-986503) either as monotherapy or in combination with other cancer therapies in patients with non-small cell lung cancer (NSCLC), colorectal cancer (CRC) and other advanced solid tumors.

Study Overview

• Status: Recruiting
• Conditions: Solid Tumors
• Intervention / Treatment: Drug: Pemetrexed; Drug: Docetaxel; Drug: Fluorouracil; Drug: Pembrolizumab; Drug: Cetuximab; Drug: Oxaliplatin; Drug: Leucovorin; Drug: Irinotecan; Drug: Adagrasib

• Study Type: Interventional
• Enrollment (Estimated): 170
• Phase: Phase 2

Contacts and Locations

• 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
  • New South Wales
    • St Leonards, New South Wales, Australia, 2065
      • Not yet recruiting
      • Local Institution - 0093
      • Contact: Site 0093
• Belgium
  • Ghent, Belgium, 9000
    • Not yet recruiting
    • Local Institution - 0033
    • Contact: Site 0033
• Canada
  • British Columbia
    • Vancouver, British Columbia, Canada, V5Z 4E6
      • Not yet recruiting
      • Local Institution - 0072
      • Contact: Site 0072
• France
  • Besançon, France, 25030
    • Not yet recruiting
    • Local Institution - 0091
    • Contact: Site 0091
  • Bron, France, 69500
    • Not yet recruiting
    • Local Institution - 0090
    • Contact: Site 0090
  • Créteil, France, 94010
    • Not yet recruiting
    • Local Institution - 0085
    • Contact: Site 0085
  • Grenoble, France, 38043
    • Not yet recruiting
    • Local Institution - 0065
    • Contact: Site 0065
  • Marseille, France, 13915
    • Not yet recruiting
    • Local Institution - 0059
    • Contact: Site 0059
  • Nice, France, 06189
    • Not yet recruiting
    • Local Institution - 0086
    • Contact: Site 0086
  • Poitiers, France, 86021
    • Not yet recruiting
    • Local Institution - 0051
    • Contact: Site 0051
  • Saint-Herblain, France, 44800
    • Not yet recruiting
    • Local Institution - 0063
    • Contact: Site 0063
  • Saint-Herblain, France, 44805
    • Not yet recruiting
    • Local Institution - 0050
    • Contact: Site 0050
  • Saint-Mandé, France, 94163
    • Not yet recruiting
    • Local Institution - 0078
    • Contact: Site 0078
  • Strasbourg, France, 67000
    • Not yet recruiting
    • Local Institution - 0074
    • Contact: Site 0074
  • Tours, France, 37032
    • Not yet recruiting
    • Local Institution - 0077
    • Contact: Site 0077
  • Alpes-Maritimes
    • Nice, Alpes-Maritimes, France, 06000
      • Not yet recruiting
      • Local Institution - 0076
      • Contact: Site 0076
  • Aquitaine
    • Pessac, Aquitaine, France, 33600
      • Not yet recruiting
      • Local Institution - 0103
      • Contact: Site 0103
  • Brittany Region
    • Quimper, Brittany Region, France, 29000
      • Not yet recruiting
      • Local Institution - 0058
      • Contact: Site 0058
  • Maine-et-Loire
    • Angers, Maine-et-Loire, France, 49055
      • Not yet recruiting
      • Local Institution - 0032
      • Contact: Site 0032
  • Rhône
    • Gleizé, Rhône, France, 69400
      • Not yet recruiting
      • Local Institution - 0075
      • Contact: Site 0075
  • Île-de-France Region
    • Paris, Île-de-France Region, France, 75014
      • Not yet recruiting
      • Local Institution - 0061
      • Contact: Site 0061
• Germany
  • München, Germany, 81737
    • Not yet recruiting
    • Local Institution - 0012
    • Contact: Site 0012
• Greece
  • Attiki, Greece, 18547
    • Not yet recruiting
    • Local Institution - 0022
    • Contact: Site 0022
  • Thessaloniki, Greece, 54639
    • Not yet recruiting
    • Local Institution - 0087
    • Contact: Site 0087
  • Attikí
    • Athens, Attikí, Greece, 115 28
      • Not yet recruiting
      • Local Institution - 0081
      • Contact: Site 0081
• Israel
  • Tel Aviv, Israel, 6423906
    • Not yet recruiting
    • Local Institution - 0106
    • Contact: Site 0106
  • Jerusalem
    • Jerusalem, Jerusalem, Israel, 9103102
      • Not yet recruiting
      • Local Institution - 0055
      • Contact: Site 0055
  • Tel Aviv
    • Tel Aviv, Tel Aviv, Israel, 62748
      • Not yet recruiting
      • Local Institution - 0057
      • Contact: Site 0057
• Italy
  • Bologna, Italy, 40138
    • Not yet recruiting
    • Local Institution - 0053
    • Contact: Site 0053
  • Florence, Italy, 50139
    • Not yet recruiting
    • Local Institution - 0054
    • Contact: Site 0054
  • Meldola, Italy, 47014
    • Not yet recruiting
    • Local Institution - 0052
    • Contact: Site 0052
  • Milan, Italy, 20141
    • Not yet recruiting
    • Local Institution - 0021
    • Contact: Site 0021
  • Milan, Italy, 20141
    • Not yet recruiting
    • Local Institution - 0107
    • Contact: Site 0107
  • Orbassano, Italy, 10043
    • Not yet recruiting
    • Local Institution - 0020
    • Contact: Site 0020
  • Pesaro, Italy, 61122
    • Not yet recruiting
    • Local Institution - 0079
    • Contact: Site 0079
  • Roma, Italy, 00168
    • Not yet recruiting
    • Local Institution - 0031
    • Contact: Site 0031
  • Terni (Perugia), Italy, 6156
    • Not yet recruiting
    • Local Institution - 0026
    • Contact: Site 0026
  • Roma
    • Rome, Roma, Italy, 00144
      • Not yet recruiting
      • Local Institution - 0019
      • Contact: Site 0019
• Netherlands
  • Amsterdam, Netherlands, 1006 BE
    • Not yet recruiting
    • Local Institution - 0034
    • Contact: Site 0034
  • Harderwijk, Netherlands, 3844 DG
    • Not yet recruiting
    • Local Institution - 0035
    • Contact: Site 0035
  • Utrecht, Netherlands, 3543 AZ
    • Not yet recruiting
    • Local Institution - 0071
    • Contact: Site 0071
  • North Brabant
    • Breda, North Brabant, Netherlands, 4818 CK
      • Not yet recruiting
      • Local Institution - 0056
      • Contact: Site 0056
• Portugal
  • Lisbon District
    • Lisbon, Lisbon District, Portugal, 1099-023
      • Not yet recruiting
      • Local Institution - 0014
      • Contact: Site 0014
• Romania
  • Dolj
    • Craiova, Dolj, Romania, 200746
      • Not yet recruiting
      • Local Institution - 0060
      • Contact: Site 0060
• Singapore
  • Central Singapore
    • Singapore, Central Singapore, Singapore, 168583
      • Not yet recruiting
      • Local Institution - 0088
      • Contact: Site 0088
• Spain
  • Barcelona, Spain, 08035
    • Not yet recruiting
    • Local Institution - 0029
    • Contact: Site 0029
  • Córdoba, Spain, 14004
    • Not yet recruiting
    • Local Institution - 0027
    • Contact: Site 0027
  • Madrid, Spain, 28007
    • Not yet recruiting
    • Local Institution - 0083
    • Contact: Site 0083
  • Madrid, Spain, 28040
    • Not yet recruiting
    • Local Institution - 0015
    • Contact: Site 0015
  • Madrid, Spain, 28041
    • Not yet recruiting
    • Local Institution - 0062
    • Contact: Site 0062
  • Málaga, Spain, 29011
    • Not yet recruiting
    • Local Institution - 0018
    • Contact: Site 0018
  • Seville, Spain, 41009
    • Not yet recruiting
    • Local Institution - 0008
    • Contact: Site 0008
  • A Coruña [La Coruña]
    • A Coruña, A Coruña [La Coruña], Spain, 15006
      • Not yet recruiting
      • Local Institution - 0007
      • Contact: Site 0007
  • Balears [Baleares]
    • Palma, Balears [Baleares], Spain, 07120
      • Not yet recruiting
      • Local Institution - 0011
      • Contact: Site 0011
  • Barcelona
    • Badalona, Barcelona, Spain, 08916
      • Not yet recruiting
      • Local Institution - 0006
      • Contact: Site 0006
  • Barcelona [Barcelona]
    • Barcelona, Barcelona [Barcelona], Spain, 08028
      • Not yet recruiting
      • Local Institution - 0010
      • Contact: Site 0010
  • Cantabria
    • Santander, Cantabria, Spain, 39008
      • Not yet recruiting
      • Local Institution - 0030
      • Contact: Site 0030
  • Madrid, Comunidad de
    • Madrid, Madrid, Comunidad de, Spain, 28034
      • Not yet recruiting
      • Local Institution - 0024
      • Contact: Site 0024
  • Navarre
    • Pamplona, Navarre, Spain, 31008
      • Not yet recruiting
      • Local Institution - 0009
      • Contact: Site 0009
  • Valenciana, Comunitat
    • Valencia, Valenciana, Comunitat, Spain, 46010
      • Not yet recruiting
      • Local Institution - 0084
      • Contact: Site 0084
• United States
  • Arizona
    • Phoenix, Arizona, United States, 85054
      • Withdrawn
      • Local Institution - 0005
  • California
    • Bellflower, California, United States, 90706
      • Not yet recruiting
      • Local Institution - 0016
      • Contact: Site 0016
    • Long Beach, California, United States, 90806
      • Not yet recruiting
      • Local Institution - 0082
      • Contact: Site 0082
  • Delaware
    • Newark, Delaware, United States, 19713
      • Withdrawn
      • Local Institution - 0003
  • Florida
    • St. Petersburg, Florida, United States, 33701
      • Not yet recruiting
      • Local Institution - 0001
      • Contact: Site 0001
  • Illinois
    • Chicago, Illinois, United States, 60637
      • Not yet recruiting
      • Local Institution - 0064
      • Contact: Site 0064
  • Kansas
    • Wichita, Kansas, United States, 67208
      • Not yet recruiting
      • Local Institution - 0112
      • Contact: Site 0112
  • Massachusetts
    • Boston, Massachusetts, United States, 00215
      • Not yet recruiting
      • Local Institution - 0092
      • Contact: Site 0092
    • Boston, Massachusetts, United States, 02215
      • Not yet recruiting
      • Local Institution - 0080
      • Contact: Site 0080
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Recruiting
      • Mayo Clinic in Rochester, Minnesota
      • Contact: Konstantinos Leventakos, Site 0017; Phone Number: 507-284-2511
    • Saint Paul, Minnesota, United States, 55101
      • Not yet recruiting
      • Local Institution - 0073
      • Contact: Site 0073
  • Nebraska
    • Omaha, Nebraska, United States, 68114
      • Not yet recruiting
      • Local Institution - 0036
      • Contact: Site 0036
  • New York
    • New York, New York, United States, 10065 6800
      • Not yet recruiting
      • Local Institution - 0116
      • Contact: Site 0116
  • Oregon
    • Eugene, Oregon, United States, 97401
      • Not yet recruiting
      • Local Institution - 0004
      • Contact: Site 0004
  • Tennessee
    • Germantown, Tennessee, United States, 38138
      • Not yet recruiting
      • Local Institution - 0023
      • Contact: Site 0023
  • Texas
    • Grapevine, Texas, United States, 76051
      • Not yet recruiting
      • Local Institution - 0002
      • Contact: Site 0002
  • Washington
    • Bellingham, Washington, United States, 98225
      • Not yet recruiting
      • Local Institution - 0013
      • Contact: Site 0013

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Participant is eligible to receive continued study treatment as per the parent study, and/or investigator assessed clinical benefit.
• Individuals with assigned female sex at birth (AFSB) must have documented proof that they are not of childbearing potential. IOCBP participants who are sexually active must agree to follow the instructions for method(s) of contraception and included in the ICF.

Exclusion Criteria:

• Participant is not eligible for study treatment per the parent study eligibility criteria.
• Participants who have completed treatment with the study drugs, progressed on prior study treatment, or discontinued study treatment due to toxicity in the parent study are not eligible to receive study drug in this study.
• Participants not receiving clinical benefit from parent study drug as assessed by the investigator.

Other protocol defined inclusion/exclusion criteria applies.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

10

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Arm B1	Drug: Pembrolizumab; Specified dose on specified days; Drug: Adagrasib; Specified dose on specified days; Other Names: BMS-986503
Experimental: Arm B2	Drug: Pembrolizumab; Specified dose on specified days; Drug: Adagrasib; Specified dose on specified days; Other Names: BMS-986503
Experimental: Arm C1	Drug: Pembrolizumab; Specified dose on specified days
Experimental: Arm C2	Drug: Docetaxel; Specified dose on specified days
Experimental: Arm A1	Drug: Adagrasib; Specified dose on specified days; Other Names: BMS-986503
Experimental: Arm A2	Drug: Adagrasib; Specified dose on specified days; Other Names: BMS-986503
Experimental: Arm B3	Drug: Cetuximab; Specified dose on specified days; Drug: Adagrasib; Specified dose on specified days; Other Names: BMS-986503
Experimental: Arm B4	Drug: Pemetrexed; Specified dose on specified days; Drug: Pembrolizumab; Specified dose on specified days; Drug: Adagrasib; Specified dose on specified days; Other Names: BMS-986503
Experimental: Arm C3	Drug: Fluorouracil; Specified dose on specified days; Drug: Leucovorin; Specified dose on specified days; Other Names: Folinic acid; Drug: Irinotecan; Specified dose on specified days
Experimental: Arm C4	Drug: Fluorouracil; Specified dose on specified days; Drug: Oxaliplatin; Specified dose on specified days; Drug: Leucovorin; Specified dose on specified days; Other Names: Folinic acid

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Number of Participants With Adverse Events (AEs)	Up to 90 days from last dose or study discontinuation
Number of Participants With AEs Leading to Treatment Discontinuation	Up to 90 days from last dose or study discontinuation
Number of Participants With Serious Adverse Events (SAEs)	Up to 90 days from last dose or study discontinuation
Number of Participants With AEs Leading to Death	Up to 90 days from last dose or study discontinuation

Collaborators and Investigators

• Sponsor: Mirati Therapeutics Inc.
• Investigators: Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb

Publications and helpful links

Helpful Links

• BMS Clinical Trial Information
• BMS Clinical Trial Patient Recruiting

Study record dates

Study Major Dates

• Study Start (Actual): May 6, 2026
• Primary Completion (Estimated): February 16, 2028
• Study Completion (Estimated): February 16, 2028

Study Registration Dates

• First Submitted: February 11, 2026
• First Submitted That Met QC Criteria: February 11, 2026
• First Posted (Actual): February 17, 2026

Study Record Updates

• Last Update Posted (Actual): May 15, 2026
• Last Update Submitted That Met QC Criteria: May 13, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: NSCLC; KRAS G12C; KRAS; CRC; Adagrasib; Krazati
• Additional Relevant MeSH Terms: Amino Acids, Peptides, and Proteins; Proteins; Organic Chemicals; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Hydrocarbons; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Terpenes; Camptothecin; Alkaloids; Enzymes and Coenzymes; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Serum Globulins; Globulins; Coordination Complexes; Guanine; Hypoxanthines; Purinones; Purines; Glutamates; Amino Acids, Acidic; Amino Acids; Amino Acids, Dicarboxylic; Taxoids; Cyclodecanes; Diterpenes; Pyrimidines; Formyltetrahydrofolates; Tetrahydrofolates; Folic Acid; Pterins; Pteridines; Uracil; Pyrimidinones; Coenzymes; Docetaxel; Oxaliplatin; Irinotecan; Pemetrexed; Cetuximab; Fluorouracil; Leucovorin; pembrolizumab; adagrasib
• Other Study ID Numbers: CA239-0071; WHO (Other Identifier: U1111-1322-9071); EU CTR (Other Identifier: 2025-522400-24)

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