Recruiting
Phase 3

Amivantamab & Cetuximab

Sponsor:

Janssen Research & Development, LLC

Code:

NCT06750094

Conditions

Colorectal Neoplasms

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Amivantamab

Cetuximab

Bevacizumab

5-fluorouracil

Leucovorin calcium/Levoleucovorin

Study Details

Brief summary:

The purpose of this study is to compare how long the participants are disease-free (progression-free survival) and and the length of time until a participant dies (overall survival), when treated with amivantamab and chemotherapy with 5-fluorouracil, leucovorin calcium (folinic acid) or levoleucovorin, and irinotecan hydrochloride (FOLFIRI) versus either cetuximab or bevacizumab and FOLFIRI given to participants with Kirsten rat sarcoma viral oncogene/ neuroblastoma RAS viral oncogene homolog (KRAS/ NRAS) and v-raf murine sarcoma viral oncogene homolog B (BRAF) wild-type recurrent, unresectable or metastatic colorectal cancer who have previously received chemotherapy.

Conditions

Colorectal Neoplasms

Study ID

NCT06750094

Start date

Dec 12, 2024

Status verified date

Aug, 2026

Completion date

Apr 13, 2029

Anticipated

Primary completion date

Dec 15, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Have histologically or cytologically confirmed adenocarcinoma of the colon or rectum. Participants must have recurrent, unresectable or metastatic disease
  • Determined to have kirsten rat sarcoma viral oncogene/neuroblastoma RAS viral oncogene homolog (KRAS/NRAS), G12, G13 and v-raf murine sarcoma viral oncogene homolog B (BRAF) V600X (X represents any single amino acid change from the original amino acid) wild type status by local and/or central next-generation sequencing (NGS) testing
  • Must agree to the submission of fresh or archival tumor tissue post progression from the most recent therapy, if clinically feasible
  • Have measurable disease according to response evaluation criteria in solid tumors (RECIST) version (v) 1.1
  • Have an eastern cooperative oncology group (ECOG) performance status (PS) of 0 or 1
  • Participant must have received 1 line of systemic therapy (fluoropyrimidine-based and oxaliplatin-based) for metastatic colorectal cancer (mCRC), with documented radiographic disease progression on or after this line of therapy. Participants can receive anti-VEGF as prior line of therapy

Exclusion Criteria:

  • Has medical history of (noninfectious) interstitial lung disease (ILD) /pneumonitis/pulmonary fibrosis or has current ILD/pneumonitis/pulmonary fibrosis, or where suspected ILD/pneumonitis/pulmonary fibrosis cannot be ruled out by imaging at screening
  • Has known allergies, hypersensitivity, or intolerance to excipients of any of the following: amivantamab, cetuximab or bevacizumab or any component of FOLFIRI
  • Has a prior or concurrent second malignancy other than the disease under study or one whose natural history or treatment is likely to interfere with any study endpoints of safety or the efficacy of the study treatment(s)
  • Participant with known mismatch repair deficiency (dMMR)/ high microsatellite instability (MSI-H) status who has not received immunotherapy treatments
  • Participant with known human epidermal growth factor receptor 2 (HER2)- positive/amplified tumor
  • Has prior exposure to irinotecan, any agents that target epidermal growth factor receptor (EGFR) or mesenchymal epithelial transition (MET)

Study Design

Enrollment

700 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Arm A: Amivantamab + FOLFIRI

Participants will receive amivantamab along with FOLFIRI (consisting of 5-fluorouracil, leucovorin calcium \[folinic acid\] or levoleucovorin, and irinotecan) as a chemotherapy regimen for 28-days treatment cycles and will continue to receive the treatment until radiographic disease progression or other discontinuation criteria are met.

active comparator: Arm B: Cetuximab or Bevacizumab + FOLFIRI

Participants will receive either cetuximab or bevacizumab along with FOLFIRI as a chemotherapy regimen for 28-days treatment cycles and will continue to receive the treatment until radiographic disease progression or other discontinuation criteria are met.

Interventions

Amivantamab

Amivantamab will be administered.

Cetuximab

Cetuximab will be administered.

Bevacizumab

Bevacizumab will be administered.

5-fluorouracil

5-fluorouracil will be administered as chemotherapy regimen.

Leucovorin calcium/Levoleucovorin

Leucovorin calcium/Levoleucovorin will be administered as chemotherapy regimen.

Irinotecan

Irinotecan will be administered as chemotherapy regimen.

Primary outcome measure

  • Progression-Free Survival (PFS) as Assessed by Blinded Independent Central Review (BICR) [ Time Frame: Up to 2 years 1 month ]
  • Overall Survival (OS) [ Time Frame: Up to 4 years 4 months ]

Central Contacts and Locations

Central contacts

Study Contact

844-434-4210Participate-In-This-Study1@its.jnj.com

Locations

Ironwood Cancer and Research Center

Recruiting

Chandler, Arizona, United States, 85224

Banner MD Anderson Cancer Center

Recruiting

Gilbert, Arizona, United States, 85234

St. Bernard's Medical Center

Recruiting

Jonesboro, Arkansas, United States, 72401

Highlands Oncology Group

Recruiting

Springdale, Arkansas, United States, 72762

CBCC Global Research

Recruiting

Bakersfield, California, United States, 93309

Los Angeles Cancer Network

Recruiting

Glendale, California, United States, 91204

Cancer and Blood Specialty Clinic

Recruiting

Los Alamitos, California, United States, 90720

USC Norris Comprehensive Cancer Center

Recruiting

Los Angeles, California, United States, 90033

UCLA

Recruiting

Santa Monica, California, United States, 90404

Providence Medical Foundation

Recruiting

Santa Rosa, California, United States, 95403

Torrance Memorial Physicians Network

Recruiting

Torrance, California, United States, 90505

University of Colorado Denver Anschultz Medical Campus

Recruiting

Aurora, Colorado, United States, 80045

Rocky Mountain Cancer Centers

Recruiting

Denver, Colorado, United States, 80218

Florida Cancer Specialists South

Recruiting

Fort Myers, Florida, United States, 33901

AdventHealth Cancer Institute

Recruiting

Orlando, Florida, United States, 32804

Florida Cancer Specialists North Region

Recruiting

St. Petersburg, Florida, United States, 33701-4553

Florida Cancer Specialists East

Recruiting

West Palm Beach, Florida, United States, 33401-3406

University Cancer And Blood Center LLC

Recruiting

Athens, Georgia, United States, 30607

Grady Memorial Hospital

Recruiting

Atlanta, Georgia, United States, 30303

Piedmont Cancer Institute

Recruiting

Atlanta, Georgia, United States, 30318

Winship Cancer Institute Emory University

Recruiting

Atlanta, Georgia, United States, 30322

Illinois Cancer Specialists

Recruiting

Arlington Heights, Illinois, United States, 60005

Illinois CancerCare

Recruiting

Peoria, Illinois, United States, 61615

Franciscan Health

Recruiting

Indianapolis, Indiana, United States, 46237

University of Iowa Hospitals and Clinics

Recruiting

Iowa City, Iowa, United States, 52242

Mission Cancer Blood

Recruiting

Waukee, Iowa, United States, 50263

Cancer Center of Kansas

Recruiting

Wichita, Kansas, United States, 67214

Mary Bird Perkins Cancer Center

Recruiting

Baton Rouge, Louisiana, United States, 70809

MedStar Franklin Square Medical Center

Recruiting

Baltimore, Maryland, United States, 21237

Frederick Health Hospital - James M Stockman Cancer Institute

Recruiting

Frederick, Maryland, United States, 21702

University of Michigan Rogel Cancer Center

Recruiting

Ann Arbor, Michigan, United States, 48109

Henry Ford Hospital

Recruiting

Detroit, Michigan, United States, 48202

Cancer And Hematology Centers of Western Michigan PC

Recruiting

Grand Rapids, Michigan, United States, 49503

Hattiesburg Clinic

Recruiting

Hattiesburg, Mississippi, United States, 39401

Washington University School Of Medicine

Recruiting

St Louis, Missouri, United States, 63110

Nebraska Cancer Specialists

Recruiting

Omaha, Nebraska, United States, 68130

Astera Cancer Care

Recruiting

East Brunswick, New Jersey, United States, 08816

Perlmutter Cancer Center at NYU Long Island

Recruiting

Mineola, New York, United States, 11501

NYU Langone Medical Center NYU Hematology Associates

Recruiting

New York, New York, United States, 10016

New York Cancer and Blood Specialists

Recruiting

Shirley, New York, United States, 11967

Montefiore Einstein Comprehensive Cancer Center

Recruiting

The Bronx, New York, United States, 10461

University of Buffalo Kaleida Health Cancer Care

Recruiting

Williamsville, New York, United States, 14221

Gabrail Cancer Center

Recruiting

Canton, Ohio, United States, 44718

University Hospital of Cleveland

Recruiting

Cleveland, Ohio, United States, 44106

Oregon Health And Science University

Recruiting

Portland, Oregon, United States, 97239

Alliance Cancer Specialists at Main Line

Recruiting

Penn Wynne, Pennsylvania, United States, 19096

Thomas Jefferson University

Recruiting

Philadelphia, Pennsylvania, United States, 19107

Fox Chase Cancer Center

Recruiting

Philadelphia, Pennsylvania, United States, 19111

University Of Pittsburgh Medical Center UPMC Hillman Cancer Center

Recruiting

Pittsburgh, Pennsylvania, United States, 15232 1301

Tennessee Oncology Chattanooga

Recruiting

Chattanooga, Tennessee, United States, 37404

SCRI Oncology Partners

Recruiting

Nashville, Tennessee, United States, 37203

Tennessee Oncology

Recruiting

Nashville, Tennessee, United States, 37203

Vanderbilt University Medical Center

Recruiting

Nashville, Tennessee, United States, 37232

Texas Oncology West Texas

Recruiting

Abilene, Texas, United States, 79606

Parkland Health and Hospital System

Recruiting

Dallas, Texas, United States, 75235

Texas Oncology DFW

Recruiting

Dallas, Texas, United States, 75246

UT Southwestern Medical Center

Recruiting

Dallas, Texas, United States, 75390

MD Anderson Cancer Center

Recruiting

Houston, Texas, United States, 77030

Baylor Scott & White Medical Center

Recruiting

Round Rock, Texas, United States, 77845

Texas Oncology - San Antonio

Recruiting

San Antonio, Texas, United States, 78240

Scott And White Memorial Hospital

Recruiting

Temple, Texas, United States, 76508

UT Health East Texas HOPE Cancer Center

Recruiting

Tyler, Texas, United States, 75701

Virginia Cancer Specialists

Recruiting

Arlington, Virginia, United States, 22201

Richmond VA Medical Center

Recruiting

Richmond, Virginia, United States, 23249

VCU Massey Comprehensive Cancer Center

Recruiting

Richmond, Virginia, United States, 23298

Providence Regional Cancer System

Recruiting

Lacey, Washington, United States, 98503

Fred Hutchinson Cancer Research Center

Recruiting

Seattle, Washington, United States, 98109

Medical College Of Wisconsin

Recruiting

Milwaukee, Wisconsin, United States, 53226

More Information

Sponsor

Janssen Research & Development, LLC

Last update posted

Aug 28, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Janssen Research & Development, LLC on 2026-08-28.