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NCT06750094PHASE3Recruiting

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

Janssen Research & Development, LLC

Start Date

12/12/2024

Completion Date

4/13/2029

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.

Eligibility Criteria

Age Range: 18 years to No maximum

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)

Interventions

BIOLOGICAL

Amivantamab

BIOLOGICAL

Cetuximab

BIOLOGICAL

Bevacizumab

DRUG

5-fluorouracil

DRUG

Leucovorin calcium/Levoleucovorin

DRUG

Irinotecan

Interested in This Trial?

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Conditions

Colorectal Neoplasms

Locations

Ironwood Cancer and Research Center

Chandler, Arizona 85224

United States

Banner MD Anderson Cancer Center

Gilbert, Arizona 85234

United States

Arizona Oncology Associates PC NAHOA

Prescott, Arizona 86301

United States

St. Bernard's Medical Center

Jonesboro, Arkansas 72401

United States

Highlands Oncology Group

Springdale, Arkansas 72762

United States

CBCC Global Research

Bakersfield, California 93309

United States

Los Angeles Cancer Network

Glendale, California 91204

United States

Cancer and Blood Specialty Clinic

Los Alamitos, California 90720

United States

USC Norris Comprehensive Cancer Center

Los Angeles, California 90033

United States

UCLA

Santa Monica, California 90404

United States

Providence Medical Foundation

Santa Rosa, California 95403

United States

Torrance Memorial Physicians Network

Torrance, California 90505

United States

University of Colorado Denver Anschultz Medical Campus

Aurora, Colorado 80045

United States

Rocky Mountain Cancer Centers

Denver, Colorado 80218

United States

Eastern Connecticut Hematology & Oncology Assoc.

Norwich, Connecticut 06360

United States

Florida Cancer Specialists South

Fort Myers, Florida 33901

United States

Mount Sinai Medical Center Campus

Miami Beach, Florida 33140

United States

AdventHealth Cancer Institute

Orlando, Florida 32804

United States

Florida Cancer Specialists North Region

St. Petersburg, Florida 33701-4553

United States

Florida Cancer Specialists East

West Palm Beach, Florida 33401-3406

United States

University Cancer And Blood Center LLC

Athens, Georgia 30607

United States

Grady Memorial Hospital

Atlanta, Georgia 30303

United States

Piedmont Cancer Institute

Atlanta, Georgia 30318

United States

Winship Cancer Institute Emory University

Atlanta, Georgia 30322

United States

Illinois Cancer Specialists

Arlington Heights, Illinois 60005

United States

Illinois CancerCare

Peoria, Illinois 61615

United States

Franciscan Health

Indianapolis, Indiana 46237

United States

University of Iowa Hospitals and Clinics

Iowa City, Iowa 52242

United States

Mission Cancer Blood

Waukee, Iowa 50263

United States

Cancer Center of Kansas

Wichita, Kansas 67214

United States

Mary Bird Perkins Cancer Center

Baton Rouge, Louisiana 70809

United States

MedStar Franklin Square Medical Center

Baltimore, Maryland 21237

United States

Frederick Health Hospital - James M Stockman Cancer Institute

Frederick, Maryland 21702

United States

University of Michigan Rogel Cancer Center

Ann Arbor, Michigan 48109

United States

Henry Ford Hospital

Detroit, Michigan 48202

United States

Cancer And Hematology Centers of Western Michigan PC

Grand Rapids, Michigan 49503

United States

Hattiesburg Clinic

Hattiesburg, Mississippi 39401

United States

Washington University School Of Medicine

St Louis, Missouri 63110

United States

Nebraska Cancer Specialists

Omaha, Nebraska 68130

United States

Astera Cancer Care

East Brunswick, New Jersey 08816

United States

Perlmutter Cancer Center at NYU Long Island

Mineola, New York 11501

United States

NYU Langone Medical Center NYU Hematology Associates

New York, New York 10016

United States

New York Cancer and Blood Specialists

Shirley, New York 11967

United States

Montefiore Einstein Comprehensive Cancer Center

The Bronx, New York 10461

United States

Gabrail Cancer Center

Canton, Ohio 44718

United States

University Hospital of Cleveland

Cleveland, Ohio 44106

United States

Oregon Health And Science University

Portland, Oregon 97239

United States

Alliance Cancer Specialists at Main Line

Penn Wynne, Pennsylvania 19096

United States

Thomas Jefferson University

Philadelphia, Pennsylvania 19107

United States

Fox Chase Cancer Center

Philadelphia, Pennsylvania 19111

United States

University Of Pittsburgh Medical Center UPMC Hillman Cancer Center

Pittsburgh, Pennsylvania 15232 1301

United States

Tennessee Oncology Chattanooga

Chattanooga, Tennessee 37404

United States

SCRI Oncology Partners

Nashville, Tennessee 37203

United States

Tennessee Oncology

Nashville, Tennessee 37203

United States

Vanderbilt University Medical Center

Nashville, Tennessee 37232

United States

Texas Oncology West Texas

Abilene, Texas 79606

United States

Parkland Health and Hospital System

Dallas, Texas 75235

United States

Texas Oncology DFW

Dallas, Texas 75246

United States

UT Southwestern Medical Center

Dallas, Texas 75390

United States

MD Anderson Cancer Center

Houston, Texas 77030

United States

Baylor Scott & White Medical Center

Round Rock, Texas 77845

United States

Texas Oncology - San Antonio

San Antonio, Texas 78240

United States

Scott And White Memorial Hospital

Temple, Texas 76508

United States

UT Health East Texas HOPE Cancer Center

Tyler, Texas 75701

United States

Virginia Cancer Specialists

Arlington, Virginia 22201

United States

Richmond VA Medical Center

Richmond, Virginia 23249

United States

VCU Massey Comprehensive Cancer Center

Richmond, Virginia 23298

United States

Providence Regional Cancer System

Lacey, Washington 98503

United States

Fred Hutchinson Cancer Research Center

Seattle, Washington 98109

United States

Medical College Of Wisconsin

Milwaukee, Wisconsin 53226

United States

Concord Hospital

Concord, 2139

Australia

Warringal Private Hospital

Heidelberg, 3084

Australia

Queen Elizabeth Hospital

South Woodville, 5011

Australia

Western Health Sunshine Hospital

St Albans, 3021

Australia

Institut Jules Bordet

Anderlecht, 1070

Belgium

UZ Antwerpen

Edegem, 2650

Belgium

AZ Maria Middelares

Ghent, 9000

Belgium

Jolimont

Haine Saint Paul La Louviere, 7100

Belgium

Az Groeninge

Kortrijk, 8500

Belgium

Universitair Ziekenhuis Leuven

Leuven, 3000

Belgium

Centre Hospitalier Universitaire de Liege Domaine Universitaire du Sart Tilman

Liège, 4000

Belgium

Fundacao Pio XII

Barretos, 14780 070

Brazil

Fundacao Universidade de Caxias do Sul

Caxias do Sul, 95070 560

Brazil

Fundacao Doutor Amaral Carvalho

Jaú, 17210 080

Brazil

Hospital Nossa Senhora da Conceicao S A

Porto Alegre, 91350 200

Brazil

Hospital Santa Izabel Santa Casa de Misericordia da Bahia

Salvador, 40050 410

Brazil

Fundacao Faculdade Regional De Medicina S Jose Rio Preto Hospital De Base

São José do Rio Preto, 15090 000

Brazil

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

São Paulo, 01246 000

Brazil

Fundacao Antonio Prudente A C Camargo Cancer Center

São Paulo, 01509 900

Brazil

Sociedade Beneficente Israelita Brasileira Hospital Albert Einstein

São Paulo, 05651 900

Brazil

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

Vitória, 29043 260

Brazil

Peking University First Hospital

Beijing, 100034

China

Beijing Friendship Hospital Capital Medical University

Beijing, 100050

China

Beijing Cancer Hospital

Beijing, 100142

China

The First Bethune Hospital of Jilin University

Changchun, 130021

China

Hunan Cancer hospital

Changsha, 410013

China

West China Hospital of Sichuan University

Chengdu, 610041

China

Ganzhou Cancer Hospital

Ganzhou, 341000

China

Sun Yat Sen University Cancer Center

Guangzhou, 100142

China

The Sixth Affiliated Hospital Sun Yat sen University

Guangzhou, 510655

China

Guangdong Provincial People's Hospital

Guangzhou, 519041

China

The Second Affiliated Hospital of Zhejiang University

Hangzhou, 310009

China

Zhejiang Cancer Hospital

Hangzhou, 310022

China

Harbin medical university cancer hospital

Harbin, 150081

China

Huizhou Central People's Hospital

Huizhou, 516001

China

Gansu Provincial Cancer Hospital

Lanzhou, 730050

China

The First Affiliated Hospital of NanChang University

Nanchang, 330006

China

Fudan University Shanghai Cancer Center

Shanghai, 200032

China

Liaoning Cancer Hospital and Institute

Shenyang, 110042

China

Tianjin Medical University Cancer Institute and Hospital

Tianjin, 300060

China

Hubei Cancer Hospital

Wuhan, 430079

China

Institut Sainte Catherine

Avignon, 84918

France

Hopital Haut Leveque

Pessac, 33604

France

CHU De Poitiers

Poitiers, 86000

France

Charite Universitatsmedizin Berlin Campus Virchow Klinikum

Berlin, 13353

Germany

Krankenhaus NorthWest

Frankfurt am Main, 60488

Germany

National Center for Tumor Diseases NCT

Heidelberg, 69120

Germany

Universitatsmedizin der Johannes Gutenberg Universitat Mainz

Mainz, 55131

Germany

Klinikum der Universitaet Muenchen

Munich, 81377

Germany

Queen Mary Hospital

Hong Kong,

Hong Kong

Prince Of Wales Hospital

Shatin,

Hong Kong

Markhot Ferenc Oktatokorhaz es Rendelointezet

Eger, 3300

Hungary

Pecsi Tudomanyegyetem

Pécs, 7624

Hungary

Szegedi Tudomanyegyetem

Szeged, 6720

Hungary

Rajiv Gandhi Cancer Institute and Research Centre

Delhi, 110085

India

Asian Institute Of Gastroenterology

Hyderabad, 500032

India

B P Poddar Hospital and Medical research Limited

Kolkata, 700053

India

Tata Memorial Hospital

Mumbai, 400012

India

Safdarjung Hospital

New Delhi, 110029

India

Deenanath Mangeshkar Hospital and Research Centre

Pune, 411004

India

Mahamana Pandit Madan Mohan Malviya Cancer Centre

Varanasi, 221005

India

Christian medical

Vellore, 632004

India

Yitzhak Shamir Medical Center

Beer Yaakov, 70300

Israel

Rambam Medical Center

Haifa, 3109601

Israel

Hadassah Medical Center

Jerusalem, 9112001

Israel

Rabin Medical Center

Petah Tikva, 4941492

Israel

Sheba Medical Center

Ramat Gan, 52621

Israel

Tel Aviv Sourasky Medical Center

Tel Aviv, 6423906

Israel

Assuta MC

Tel Aviv, 69710

Israel

Fondazione del Piemonte per I Oncologia IRCC Candiolo

Candiolo, 10060

Italy

ARNAS Garibaldi P O Nesima

Catania, 95122

Italy

Careggi University Hospital

Florence, 50134

Italy

Istituto Dei Tumori Di Milano

Milan, 20133

Italy

Istituto Oncologico Veneto - IRCCS

Padova, 35128

Italy

Azienda Ospedaliero Universitaria Pisana

Pisa, 56126

Italy

Istituto Clinico Humanitas

Rozzano, 20089

Italy

Azienda Sanitaria Universitaria Friuli Centrale ASU FC

Udine, 33100

Italy

Chiba Cancer Center

Chiba, 260 0801

Japan

National Cancer Center Hospital

Chūōku, 104 0045

Japan

National Cancer Center Hospital East

Kashiwa, 277 8577

Japan

Aichi Cancer Center

Nagoya, 464-8681

Japan

National Hospital Organization Osaka National Hospital

Osaka, 540 0006

Japan

Osaka International Cancer Institute

Osaka, 541 8567

Japan

Kindai University Hospital

Sakai, 590 0197

Japan

Shizuoka Cancer Center

Shizuoka, 411 8777

Japan

The University of Osaka Hospital

Suita, 565 0871

Japan

The Cancer Institute Hospital of JFCR

Tokyo, 135 8550

Japan

Hospital Pulau Pinang

George Town, 10450

Malaysia

Hospital Raja Permaisuri Bainun

Ipoh, 30450

Malaysia

Hospital Kuala Lumpur

Kuala Lumpur, 50586

Malaysia

University Malaya Medical Centre

Kuala Lumpur, 59100

Malaysia

Hospital Umum Sarawak

Kuching, 93586

Malaysia

Institut Kanser Negara Clinical Research Center

Putrajaya, 62250

Malaysia

Centro Oncologico de Chihuahua

Chihuahua City, 31217

Mexico

Actualidad Basada En La Investigacion Del Cancer

Guadalajara, 44680

Mexico

Centro Oncologico Personalizado Cope S De R L De C V

Mexico City, 06760

Mexico

Instituto Nacional de Cancerologia

Mexico City, 14080

Mexico

Hospital Universitario Dr Jose Eleuterio Gonzalez

Monterrey, 64460

Mexico

Oncocenter

Puebla City, 72530

Mexico

Cuidados Oncologicos

Querétaro, 76000

Mexico

Health Pharma Queretaro SA de CV

Querétaro, 76230

Mexico

COI Centro Oncologico Internacional Tijuana

Tijuana, 22010

Mexico

Meander Medisch Centrum

Amersfoort, 3813 TZ

Netherlands

Antoni van Leeuwenhoek

Amsterdam, 1066 CX

Netherlands

Radboud University Medical Center

Nijmegen, 6525 GA

Netherlands

Erasmus MC

Rotterdam, 3015 GD

Netherlands

ETZ TweeSteden

Tilburg, 5042 AD

Netherlands

Bialostockie Centrum Onkologii im Marii Sklodowskiej Curie w Bialymstoku

Bialystok, 15 027

Poland

Wojewodzki Szpital Specjalistyczny

Biała Podlaska, 21 500

Poland

Szpital Specjalistyczny w Brzozowie Podkarpacki Osrodek Onkologiczny im Ks B Markiewicza

Brzozów, 36 200

Poland

Uniwersyteckie Centrum Kliniczne

Gdansk, 80 214

Poland

Narodowy Instytut Onkologii im Marii Sklodowskiej Curie Panstwowy Instytut BadawczyOddz w Gliwicach

Gliwice, 44 100

Poland

Instytut Centrum Zdrowia Matki Polki

Lodz, 93 339

Poland

Szpital Kliniczny MSWiA z WMCO

Olsztyn, 10 228

Poland

SPZOZ Opolskie Centrum Onkologii im. Prof. Tadeusza Koszarowskiego

Opole, 45 061

Poland

Narodowy Instytut Onkologii im Marii Sklodowskiej Curie Panstwowy Instytut Badawczy

Warsaw, 02 034

Poland

Pan American Center for Oncology Trials LLC

San Juan, 00935

Puerto Rico

Centrul Medical Unirea SRL

Brasov, 500091

Romania

Spitalul Memorial Baneasa

Bucharest, 013812

Romania

Ponderas Academic Hospital

Bucharest, 014142

Romania

Neolife Medical Center Bucharest

Bucharest, 077190

Romania

Institutul Oncologic 'Prof Dr. Ion Chiricuta' Cluj-Napoca

Cluj-Napoca, 400015

Romania

Clinica de Oncologie Sf Nectarie

Craiova, 200542

Romania

Institutul Regional de Oncologie Iasi

Iași, 700483

Romania

Pelican Impex SRL

Oradea, 410469

Romania

Kyungpook National University Chilgok Hospital

Daegu, 41404

South Korea

Korea University Anam Hospital

Seoul, 02841

South Korea

Seoul National University Hospital

Seoul, 03080

South Korea

Severance Hospital Yonsei University Health System

Seoul, 03722

South Korea

Asan Medical Center

Seoul, 05505

South Korea

Samsung Medical Center

Seoul, 06351

South Korea

The Catholic University of Korea Seoul St Mary s Hospital

Seoul, 06591

South Korea

Hosp. Univ. de Badajoz

Badajoz, 06006

Spain

Hosp. Del Mar

Barcelona, 08003

Spain

Hosp. de La Santa Creu I Sant Pau

Barcelona, 08025

Spain

Hosp. Univ. Quiron Dexeus

Barcelona, 08028

Spain

Hosp Univ Vall D Hebron

Barcelona, 08035

Spain

Hosp San Francisco de Asis

Madrid, 28002

Spain

Hosp. Gral. Univ. Gregorio Maranon

Madrid, 28007

Spain

Hosp. Univ. Ramon Y Cajal

Madrid, 28034

Spain

Hosp Univ Fund Jimenez Diaz

Madrid, 28040

Spain

Hosp. Univ. 12 de Octubre

Madrid, 28041

Spain

Hosp Regional Univ de Malaga

Málaga, 29010

Spain

Clinica Univ. de Navarra

Pamplona, 31008

Spain

Hosp. Virgen Del Rocio

Seville, 41013

Spain

Hosp. Clinico Univ. de Valencia

Valencia, 46010

Spain

Sahlgrenska Universitetssjukhuset

Gothenburg, 413 45

Sweden

Skanes universitetssjukhus

Lund, 222 42

Sweden

Sodersjukhuset

Stockholm, 118 83

Sweden

Karolinska Universitetssjukhuset

Stockholm, 171 76

Sweden

Uppsala University

Uppsala, SE 751 85

Sweden

Kaohsiung Medical University Chung Ho Memorial Hospital

Kaohsiung City, 80756

Taiwan

Chang Gung Memorial Hospital

Kaohsiung City, 833

Taiwan

Taichung Veterans General Hospital

Taichung, 40705

Taiwan

National Cheng Kung University Hospital

Tainan, 704

Taiwan

National Taiwan University Hospital

Taipei, 10043

Taiwan

Taipei Veterans General Hospital

Taipei, 112

Taiwan

Linkou Chang Gung Memorial Hospital

Taoyuan, 333

Taiwan

Ramathibodi Hospital

Bangkok, 10400

Thailand

Siriraj Hospital

Bangkok, 10700

Thailand

Chiang Mai University

Chiang Mai, 50200

Thailand

Songklanagarind hospital

Songkhla, 90110

Thailand

Adana City Hospital

Adana, 01060

Turkey (Türkiye)

Gulhane Egitim ve Arastirma Hastanesi

Ankara, 06010

Turkey (Türkiye)

Dr Abdurrahman Yurtaslan Oncology Training and Research Hospital

Ankara, 06200

Turkey (Türkiye)

Gazi Universitesi Hastanesi

Ankara, 06560

Turkey (Türkiye)

Ankara Bilkent Sehir Hastanesi

Ankara, 06800

Turkey (Türkiye)

Memorial Antalya Hospital

Antalya, 07025

Turkey (Türkiye)

Trakya University Medical Faculty

Edirne, 22030

Turkey (Türkiye)

Bakirkoy Training and Research Hospital

Istanbul, 34147

Turkey (Türkiye)

Marmara Universitesi Pendik Egitim ve Arastirma Hastanesi

Istanbul, 34899

Turkey (Türkiye)

Necmettin Erbakan Universitesi Tip Fakultesi Hastanesi

Konya, 42090

Turkey (Türkiye)

Sakarya University Training and Research Hospital

Sakarya, 54290

Turkey (Türkiye)

Birmingham Heartlands Hospital

Birmingham, B9 5ST

United Kingdom

Castle Hill Hospital

Hull, HU16 5JQ

United Kingdom

St James University Hospital

Leeds, LS9 7TF

United Kingdom

St Bartholomew's Hospital

London, EC1A 7BE

United Kingdom

University College Hospital

London, NW1 2BU

United Kingdom

Royal Marsden Hospital

London, SW3 6JJ

United Kingdom

Mount Vernon Cancer Centre

Northwood, HA6 2RN

United Kingdom