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RECRUITING
NCT06750094
PHASE3

A Study of Amivantamab and FOLFIRI Versus Cetuximab/Bevacizumab and FOLFIRI in Participants With KRAS/NRAS and BRAF Wild-type Colorectal Cancer Who Have Previously Received Chemotherapy

Sponsor: Janssen Research & Development, LLC

View on ClinicalTrials.gov

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.

Official title: A Randomized, Open-label Phase 3 Study of Amivantamab + FOLFIRI Versus Cetuximab/Bevacizumab + FOLFIRI in Participants With KRAS/NRAS and BRAF Wild-type Recurrent, Unresectable or Metastatic Colorectal Cancer Who Have Received Prior Chemotherapy

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

700

Start Date

2024-12-12

Completion Date

2029-04-13

Last Updated

2026-11-03

Healthy Volunteers

No

Interventions

BIOLOGICAL

Amivantamab

Amivantamab will be administered.

BIOLOGICAL

Cetuximab

Cetuximab will be administered.

BIOLOGICAL

Bevacizumab

Bevacizumab will be administered.

DRUG

5-fluorouracil

5-fluorouracil will be administered as chemotherapy regimen.

DRUG

Leucovorin calcium/Levoleucovorin

Leucovorin calcium/Levoleucovorin will be administered as chemotherapy regimen.

DRUG

Irinotecan

Irinotecan will be administered as chemotherapy regimen.

Locations (251)

Ironwood Cancer and Research Center

Chandler, Arizona, United States

Banner MD Anderson Cancer Center

Gilbert, Arizona, United States

Arizona Oncology Associates PC NAHOA

Prescott, Arizona, United States

St. Bernard's Medical Center

Jonesboro, Arkansas, United States

Highlands Oncology Group

Springdale, Arkansas, United States

CBCC Global Research

Bakersfield, California, United States

Los Angeles Cancer Network

Glendale, California, United States

Cancer and Blood Specialty Clinic

Los Alamitos, California, United States

USC Norris Comprehensive Cancer Center

Los Angeles, California, United States

UCLA

Santa Monica, California, United States

Providence Medical Foundation

Santa Rosa, California, United States

Torrance Memorial Physicians Network

Torrance, California, United States

University of Colorado Denver Anschultz Medical Campus

Aurora, Colorado, United States

Rocky Mountain Cancer Centers

Denver, Colorado, United States

Eastern Connecticut Hematology & Oncology Assoc.

Norwich, Connecticut, United States

Florida Cancer Specialists South

Fort Myers, Florida, United States

Mount Sinai Medical Center Campus

Miami Beach, Florida, United States

AdventHealth Cancer Institute

Orlando, Florida, United States

Florida Cancer Specialists North Region

St. Petersburg, Florida, United States

Florida Cancer Specialists East

West Palm Beach, Florida, United States

University Cancer And Blood Center LLC

Athens, Georgia, United States

Grady Memorial Hospital

Atlanta, Georgia, United States

Piedmont Cancer Institute

Atlanta, Georgia, United States

Winship Cancer Institute Emory University

Atlanta, Georgia, United States

Illinois Cancer Specialists

Arlington Heights, Illinois, United States

Illinois CancerCare

Peoria, Illinois, United States

Franciscan Health

Indianapolis, Indiana, United States

University of Iowa Hospitals and Clinics

Iowa City, Iowa, United States

Mission Cancer Blood

Waukee, Iowa, United States

Cancer Center of Kansas

Wichita, Kansas, United States

Mary Bird Perkins Cancer Center

Baton Rouge, Louisiana, United States

MedStar Franklin Square Medical Center

Baltimore, Maryland, United States

Frederick Health Hospital - James M Stockman Cancer Institute

Frederick, Maryland, United States

University of Michigan Rogel Cancer Center

Ann Arbor, Michigan, United States

Henry Ford Hospital

Detroit, Michigan, United States

Cancer And Hematology Centers of Western Michigan PC

Grand Rapids, Michigan, United States

Hattiesburg Clinic

Hattiesburg, Mississippi, United States

Washington University School Of Medicine

St Louis, Missouri, United States

Nebraska Cancer Specialists

Omaha, Nebraska, United States

Astera Cancer Care

East Brunswick, New Jersey, United States

Perlmutter Cancer Center at NYU Long Island

Mineola, New York, United States

NYU Langone Medical Center NYU Hematology Associates

New York, New York, United States

New York Cancer and Blood Specialists

Shirley, New York, United States

Montefiore Einstein Comprehensive Cancer Center

The Bronx, New York, United States

University of Buffalo Kaleida Health Cancer Care

Williamsville, New York, United States

Gabrail Cancer Center

Canton, Ohio, United States

University Hospital of Cleveland

Cleveland, Ohio, United States

Oregon Health And Science University

Portland, Oregon, United States

Alliance Cancer Specialists at Main Line

Penn Wynne, Pennsylvania, United States

Thomas Jefferson University

Philadelphia, Pennsylvania, United States

Fox Chase Cancer Center

Philadelphia, Pennsylvania, United States

University Of Pittsburgh Medical Center UPMC Hillman Cancer Center

Pittsburgh, Pennsylvania, United States

Tennessee Oncology Chattanooga

Chattanooga, Tennessee, United States

SCRI Oncology Partners

Nashville, Tennessee, United States

Tennessee Oncology

Nashville, Tennessee, United States

Vanderbilt University Medical Center

Nashville, Tennessee, United States

Texas Oncology West Texas

Abilene, Texas, United States

Parkland Health and Hospital System

Dallas, Texas, United States

Texas Oncology DFW

Dallas, Texas, United States

UT Southwestern Medical Center

Dallas, Texas, United States

MD Anderson Cancer Center

Houston, Texas, United States

Baylor Scott & White Medical Center

Round Rock, Texas, United States

Texas Oncology - San Antonio

San Antonio, Texas, United States

Scott And White Memorial Hospital

Temple, Texas, United States

UT Health East Texas HOPE Cancer Center

Tyler, Texas, United States

Virginia Cancer Specialists

Arlington, Virginia, United States

Richmond VA Medical Center

Richmond, Virginia, United States

VCU Massey Comprehensive Cancer Center

Richmond, Virginia, United States

Providence Regional Cancer System

Lacey, Washington, United States

Fred Hutchinson Cancer Research Center

Seattle, Washington, United States

Medical College Of Wisconsin

Milwaukee, Wisconsin, United States

Concord Hospital

Concord, Australia

Warringal Private Hospital

Heidelberg, Australia

Queen Elizabeth Hospital

South Woodville, Australia

Western Health Sunshine Hospital

St Albans, Australia

Institut Jules Bordet

Anderlecht, Belgium

UZ Antwerpen

Edegem, Belgium

AZ Maria Middelares

Ghent, Belgium

Jolimont

Haine Saint Paul La Louviere, Belgium

Az Groeninge

Kortrijk, Belgium

Universitair Ziekenhuis Leuven

Leuven, Belgium

Centre Hospitalier Universitaire de Liege Domaine Universitaire du Sart Tilman

Liège, Belgium

Fundacao Pio XII

Barretos, Brazil

Fundacao Universidade de Caxias do Sul

Caxias do Sul, Brazil

Fundacao Doutor Amaral Carvalho

Jaú, Brazil

Hospital Nossa Senhora da Conceicao S A

Porto Alegre, Brazil

Hospital Santa Izabel Santa Casa de Misericordia da Bahia

Salvador, Brazil

Funfarme Sjrp

São José do Rio Preto, Brazil

Fundacao Faculdade de Medicina - Instituto do Cancer do Estado de Sao Paulo

São Paulo, Brazil

Fundacao Antonio Prudente A C Camargo Cancer Center

São Paulo, Brazil

Sociedade Beneficente Israelita Brasileira Hospital Albert Einstein

São Paulo, Brazil

Associacao Feminina de Educacao e Combate ao Cancer Hospital Santa Rita de Cassia

Vitória, Brazil

Peking University First Hospital

Beijing, China

Beijing Friendship Hospital Capital Medical University

Beijing, China

Beijing Cancer Hospital

Beijing, China

The First Bethune Hospital of Jilin University

Changchun, China

Hunan Cancer hospital

Changsha, China

West China Hospital of Sichuan University

Chengdu, China

Ganzhou Cancer Hospital

Ganzhou, China

Sun Yat Sen University Cancer Center

Guangzhou, China

And 151 more locations on ClinicalTrials.gov