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

NCT07415031 | Recruiting Phase 2 FDA Drug

• 3 other identifiers: CA239-0071EU CTRWHO
• Study Type: interventional
• Target: 170
• Locations: 14 countries
• Sites: 77

Brief Summary

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.

Conditions

Solid Tumors

Keywords

Adagrasib; KRAS G12C; KRAS; NSCLC; CRC; Krazati

Outcome Measures

Primary Outcomes (4)

• 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

Study Arms (10)

Arm A1

EXPERIMENTAL

Drug: Adagrasib

Arm A2

EXPERIMENTAL

Drug: Adagrasib

Arm B1

EXPERIMENTAL

Drug: Adagrasib; Drug: Pembrolizumab

Arm B2

EXPERIMENTAL

Drug: Adagrasib; Drug: Pembrolizumab

Arm B3

EXPERIMENTAL

Drug: Adagrasib; Drug: Cetuximab

Arm B4

EXPERIMENTAL

Drug: Adagrasib; Drug: Pembrolizumab; Drug: Pemetrexed

Arm C1

EXPERIMENTAL

Drug: Pembrolizumab

Arm C2

EXPERIMENTAL

Drug: Docetaxel

Arm C3

EXPERIMENTAL

Drug: Irinotecan; Drug: Leucovorin; Drug: Fluorouracil

Arm C4

EXPERIMENTAL

Drug: Leucovorin; Drug: Oxaliplatin; Drug: Fluorouracil

Interventions

Adagrasib DRUG

Specified dose on specified days

Also known as: BMS-986503

Arm A1; Arm A2; Arm B1; Arm B2; Arm B3; Arm B4

Pembrolizumab DRUG

Specified dose on specified days

Arm B1; Arm B2; Arm B4; Arm C1

Cetuximab DRUG

Specified dose on specified days

Arm B3

Pemetrexed DRUG

Specified dose on specified days

Arm B4

Docetaxel DRUG

Specified dose on specified days

Arm C2

Irinotecan DRUG

Specified dose on specified days

Arm C3

Leucovorin DRUG

Specified dose on specified days

Also known as: Folinic acid

Arm C3; Arm C4

Oxaliplatin DRUG

Specified dose on specified days

Arm C4

Fluorouracil DRUG

Specified dose on specified days

Arm C3; Arm C4

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mirati Therapeutics Inc.: lead

Study Sites (77)

Local Institution - 0005

Phoenix, Arizona, 85054, United States

WITHDRAWN

Local Institution - 0016

Bellflower, California, 90706, United States

NOT YET RECRUITING

Local Institution - 0082

Long Beach, California, 90806, United States

NOT YET RECRUITING

Local Institution - 0003

Newark, Delaware, 19713, United States

WITHDRAWN

Local Institution - 0001

St. Petersburg, Florida, 33701, United States

NOT YET RECRUITING

Local Institution - 0064

Chicago, Illinois, 60637, United States

NOT YET RECRUITING

Local Institution - 0112

Wichita, Kansas, 67208, United States

NOT YET RECRUITING

Local Institution - 0092

Boston, Massachusetts, 00215, United States

NOT YET RECRUITING

Local Institution - 0080

Boston, Massachusetts, 02215, United States

NOT YET RECRUITING

Mayo Clinic in Rochester, Minnesota

Rochester, Minnesota, 55905, United States

RECRUITING

Local Institution - 0073

Saint Paul, Minnesota, 55101, United States

NOT YET RECRUITING

Local Institution - 0036

Omaha, Nebraska, 68114, United States

NOT YET RECRUITING

Local Institution - 0116

New York, New York, 10065 6800, United States

NOT YET RECRUITING

Local Institution - 0004

Eugene, Oregon, 97401, United States

NOT YET RECRUITING

Local Institution - 0023

Germantown, Tennessee, 38138, United States

NOT YET RECRUITING

Local Institution - 0002

Grapevine, Texas, 76051, United States

NOT YET RECRUITING

Local Institution - 0013

Bellingham, Washington, 98225, United States

NOT YET RECRUITING

Local Institution - 0093

St Leonards, New South Wales, 2065, Australia

NOT YET RECRUITING

Local Institution - 0033

Ghent, 9000, Belgium

NOT YET RECRUITING

Local Institution - 0072

Vancouver, British Columbia, V5Z 4E6, Canada

NOT YET RECRUITING

Local Institution - 0076

Nice, Alpes-Maritimes, 06000, France

NOT YET RECRUITING

Local Institution - 0103

Pessac, Aquitaine, 33600, France

NOT YET RECRUITING

Local Institution - 0058

Quimper, Brittany Region, 29000, France

NOT YET RECRUITING

Local Institution - 0032

Angers, Maine-et-Loire, 49055, France

NOT YET RECRUITING

Local Institution - 0075

Gleizé, Rhône, 69400, France

NOT YET RECRUITING

Local Institution - 0091

Besançon, 25030, France

NOT YET RECRUITING

Local Institution - 0090

Bron, 69500, France

NOT YET RECRUITING

Local Institution - 0085

Créteil, 94010, France

NOT YET RECRUITING

Local Institution - 0065

Grenoble, 38043, France

NOT YET RECRUITING

Local Institution - 0059

Marseille, 13915, France

NOT YET RECRUITING

Local Institution - 0086

Nice, 06189, France

NOT YET RECRUITING

Local Institution - 0051

Poitiers, 86021, France

NOT YET RECRUITING

Local Institution - 0063

Saint-Herblain, 44800, France

NOT YET RECRUITING

Local Institution - 0050

Saint-Herblain, 44805, France

NOT YET RECRUITING

Local Institution - 0078

Saint-Mandé, 94163, France

NOT YET RECRUITING

Local Institution - 0074

Strasbourg, 67000, France

NOT YET RECRUITING

Local Institution - 0077

Tours, 37032, France

NOT YET RECRUITING

Local Institution - 0061

Paris, Île-de-France Region, 75014, France

NOT YET RECRUITING

Local Institution - 0012

München, 81737, Germany

NOT YET RECRUITING

Local Institution - 0081

Athens, Attikí, 115 28, Greece

NOT YET RECRUITING

Local Institution - 0022

Attiki, 18547, Greece

NOT YET RECRUITING

Local Institution - 0087

Thessaloniki, 54639, Greece

NOT YET RECRUITING

Local Institution - 0055

Jerusalem, Jerusalem, 9103102, Israel

NOT YET RECRUITING

Local Institution - 0057

Tel Aviv, Tel Aviv, 62748, Israel

NOT YET RECRUITING

Local Institution - 0106

Tel Aviv, 6423906, Israel

NOT YET RECRUITING

Local Institution - 0019

Rome, Roma, 00144, Italy

NOT YET RECRUITING

Local Institution - 0053

Bologna, 40138, Italy

NOT YET RECRUITING

Local Institution - 0054

Florence, 50139, Italy

NOT YET RECRUITING

Local Institution - 0052

Meldola, 47014, Italy

NOT YET RECRUITING

Local Institution - 0021

Milan, 20141, Italy

NOT YET RECRUITING

Local Institution - 0107

Milan, 20141, Italy

NOT YET RECRUITING

Local Institution - 0020

Orbassano, 10043, Italy

NOT YET RECRUITING

Local Institution - 0079

Pesaro, 61122, Italy

NOT YET RECRUITING

Local Institution - 0031

Roma, 00168, Italy

NOT YET RECRUITING

Local Institution - 0026

Terni (Perugia), 6156, Italy

NOT YET RECRUITING

Local Institution - 0056

Breda, North Brabant, 4818 CK, Netherlands

NOT YET RECRUITING

Local Institution - 0034

Amsterdam, 1006 BE, Netherlands

NOT YET RECRUITING

Local Institution - 0035

Harderwijk, 3844 DG, Netherlands

NOT YET RECRUITING

Local Institution - 0071

Utrecht, 3543 AZ, Netherlands

NOT YET RECRUITING

Local Institution - 0014

Lisbon, Lisbon District, 1099-023, Portugal

NOT YET RECRUITING

Local Institution - 0060

Craiova, Dolj, 200746, Romania

NOT YET RECRUITING

Local Institution - 0088

Singapore, Central Singapore, 168583, Singapore

NOT YET RECRUITING

Local Institution - 0007

A Coruña, A Coruña [La Coruña], 15006, Spain

NOT YET RECRUITING

Local Institution - 0011

Palma, Balears [Baleares], 07120, Spain

NOT YET RECRUITING

Local Institution - 0010

Barcelona, Barcelona [Barcelona], 08028, Spain

NOT YET RECRUITING

Local Institution - 0006

Badalona, Barcelona, 08916, Spain

NOT YET RECRUITING

Local Institution - 0030

Santander, Cantabria, 39008, Spain

NOT YET RECRUITING

Local Institution - 0024

Madrid, Madrid, Comunidad de, 28034, Spain

NOT YET RECRUITING

Local Institution - 0009

Pamplona, Navarre, 31008, Spain

NOT YET RECRUITING

Local Institution - 0084

Valencia, Valenciana, Comunitat, 46010, Spain

NOT YET RECRUITING

Local Institution - 0029

Barcelona, 08035, Spain

NOT YET RECRUITING

Local Institution - 0027

Córdoba, 14004, Spain

NOT YET RECRUITING

Local Institution - 0083

Madrid, 28007, Spain

NOT YET RECRUITING

Local Institution - 0015

Madrid, 28040, Spain

NOT YET RECRUITING

Local Institution - 0062

Madrid, 28041, Spain

NOT YET RECRUITING

Local Institution - 0018

Málaga, 29011, Spain

NOT YET RECRUITING

Local Institution - 0008

Seville, 41009, Spain

NOT YET RECRUITING

Related Links

• BMS Clinical Trial Information
• BMS Clinical Trial Patient Recruiting

MeSH Terms

Interventions

adagrasib; pembrolizumab; Cetuximab; Pemetrexed; Docetaxel; Irinotecan; Leucovorin; Oxaliplatin; Fluorouracil

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Guanine; Hypoxanthines; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Glutamates; Amino Acids, Acidic; Amino Acids; Amino Acids, Dicarboxylic; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Camptothecin; Alkaloids; Formyltetrahydrofolates; Tetrahydrofolates; Folic Acid; Pterins; Pteridines; Coenzymes; Enzymes and Coenzymes; Coordination Complexes; Uracil; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Central Study Contacts

BMS Clinical Trials Contact Center www.BMSClinicalTrials.com

CONTACT

855-907-3286; Clinical.Trials@bms.com

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

CONTACT

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 11, 2026
• First Posted: February 17, 2026
• Study Start: May 6, 2026
• Primary Completion (Estimated): February 16, 2028
• Study Completion (Estimated): February 16, 2028
• Last Updated: May 15, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: See Plan Description
• Access Criteria: See Plan Description

Locations

CA (1); DE (1); US (17); RO (1); PT (1); ES (15); GR (3); IT (10); NL (4); SG (1); AU (1); BE (1); IL (3); FR (18)