Back to Trials
NCT06662786PHASE3Recruiting

A Study of Amivantamab and mFOLFOX6 or FOLFIRI Versus Cetuximab and mFOLFOX6 or FOLFIRI as First-line Treatment in Participants With KRAS/NRAS and BRAF Wild-type Unresectable or Metastatic Left-sided Colorectal Cancer

Janssen Research & Development, LLC

Start Date

10/18/2024

Completion Date

1/20/2032

Summary

The purpose of this study is to compare how long the participants are disease-free (progression-free survival) when treated with amivantamab and chemotherapy with 5-fluorouracil, leucovorin calcium (folinic acid) or levoleucovorin, oxaliplatin (mFOLFOX6) or 5-fluorouracil, leucovorin calcium (folinic acid) or levoleucovorin, and irinotecan hydrochloride (FOLFIRI) versus cetuximab and mFOLFOX6 or FOLFIRI in adult participants with Kirsten rat sarcoma viral oncogene homolog (KRAS)/ Neuroblastoma RAS viral oncogene homolog (NRAS) and v-Raf murine sarcoma viral oncogene homolog B1 (BRAF) wild type (WT) unresectable or metastatic left-sided colorectal cancer.

Eligibility Criteria

Age Range: 18 years to No maximum

Inclusion Criteria: * Have histologically or cytologically confirmed adenocarcinoma of the left-sided colorectal cancer. Participants must have unresectable or metastatic disease * Determined to have Kirsten rat sarcoma viral oncogene (KRAS), neuroblastoma RAS viral oncogene homolog (NRAS), and v-raf murine sarcoma viral oncogene homolog B (BRAF) wild-type (WT) tumor by local and/or central testing (if available) * Must agree to the submission of fresh tumor tissue * Have measurable disease according to RECIST v1.1 * Has not received any prior systemic therapy for unresectable or metastatic colorectal cancer (CRC). Prior adjuvant/neoadjuvant therapy in the non-metastatic disease is permitted. However, the last course of adjuvant or neoadjuvant chemotherapy must have concluded greater than (\>) 12 months prior to CRC recurrence/metastases * Have an eastern cooperative oncology group (ECOG) performance status (PS) of 0 or 1 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: (a) amivantamab or cetuximab, (b) any component of mFOLFOX6 and, (c) 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 and human epidermal growth factor receptor 2 (HER2)-positive/amplified tumor * Has prior exposure to any agents that target epidermal growth factor receptor (EGFR), mesenchymal epithelial transition (MET) or vascular endothelial growth factor (VEGF)

Interventions

BIOLOGICAL

Amivantamab

BIOLOGICAL

Cetuximab

DRUG

5-fluorouracil

DRUG

Leucovorin calcium/Levoleucovorin

DRUG

Oxaliplatin

DRUG

Irinotecan Hydrochloride

Interested in This Trial?

Contact the trial locations directly using the information below to learn more about enrollment.

Expressing interest lets you review the study and consent before we connect you with the research site.

Conditions

Colorectal Neoplasms

Locations

Banner MD Anderson Cancer Center

Gilbert, Arizona 85234

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

Rocky Mountain Cancer Centers

Denver, Colorado 80218

United States

Yale University School Of Medicine

New Haven, Connecticut 06519

United States

Georgetown Univ Medical Center Lombardi Cancer Center

Washington D.C., District of Columbia 20007

United States

Florida Cancer Specialists South

Fort Myers, Florida 33901

United States

AdventHealth Medical Group Oncology and Hematology at Orlando

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

Grady Memorial Hospital

Atlanta, Georgia 30303

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

Fort Wayne Medical Oncology & Hematology

Fort Wayne, Indiana 46804

United States

University of Iowa Hospital

Iowa City, Iowa 52242

United States

Mission Cancer Blood

Waukee, Iowa 50263

United States

Cancer Center of Kansas

Wichita, Kansas 67214

United States

Ochsner Clinic Foundation

New Orleans, Louisiana 70121

United States

MedStar Franklin Square Medical Center

Baltimore, Maryland 21237

United States

Frederick Health Hospital - James M Stockman Cancer Institute

Frederick, Maryland 21702-4337

United States

VA Ann Arbor Healthcare System

Ann Arbor, Michigan 48105

United States

University of Michigan

Ann Arbor, Michigan 48109

United States

Henry Ford Hospital

Detroit, Michigan 48202

United States

Start Midwest

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 Midwest Cancer Center

Omaha, Nebraska 68130

United States

Comprehensive Cancer Centers of Nevada

Las Vegas, Nevada 89169

United States

Astera Cancer Care

East Brunswick, New Jersey 08816

United States

Rutgers Cancer Institute

New Brunswick, New Jersey 08901

United States

University of New Mexico Cancer Center

Albuquerque, New Mexico 87102

United States

Perlmutter Cancer Center at NYU Long Island

Mineola, New York 11501

United States

Mount Sinai

New York, New York 10003

United States

Mount Sinai West

New York, New York 10009

United States

NYU Langone Medical Center NYU Hematology Associates

New York, New York 10016

United States

Herbert Irving Comprehensive Cancer Center Columbia University Medical Center

New York, New York 10032

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

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina 27599

United States

Gabrail Cancer Center

Canton, Ohio 44718

United States

University Hospitals Cleveland Medical Center

Cleveland, Ohio 44106

United States

Cleveland Clinic Cancer Center Fairview Hospital Moll Pavilion

Cleveland, Ohio 44111

United States

Taussig Cancer Insititute Cleveland Clinic

Cleveland, Ohio 44195

United States

Cleveland Clinic Cancer Center Independence Family Health Center

Independence, Ohio 44131

United States

Cleveland Clinic Cancer Center Mansfield

Mansfield, Ohio 44906

United States

Cleveland Clinic Cancer Center Hillcrest Hospital

Mayfield Heights, Ohio 44124

United States

Cleveland Clinic Cancer Centers Sandusky

Sandusky, Ohio 44870

United States

Cleveland Clinic Cancer Center Strongsville

Strongsville, Ohio 44136

United States

Cleveland Clinic Cancer Center South Pointe Hospital

Warrensville Heights, Ohio 44122

United States

Wooster Milltown Specialty and Surgery Center

Wooster, Ohio 44691

United States

St Charles Medical Center

Bend, Oregon 97701

United States

Oregon Health And Science University

Portland, Oregon 97239

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

SCRI Oncology Partners

Nashville, Tennessee 37203

United States

Texas Oncology West Texas

Abilene, Texas 79606

United States

Texas Oncology DFW

Dallas, Texas 75246

United States

UT Southwestern

Dallas, Texas 75390

United States

MD Anderson Cancer Center

Houston, Texas 77030

United States

Baylor Scott and White Health 1

Round Rock, Texas 78665

United States

Texas Oncology - San Antonio

San Antonio, Texas 78240

United States

Baylor Scott and White Health

Temple, Texas 76508

United States

Virginia Cancer Specialists

Arlington, Virginia 22201

United States

Inova Schar Cancer Institute Dept of Fairfax Hospital

Fairfax, Virginia 22031

United States

Richmond VA Medical Center

Richmond, Virginia 23249

United States

VCU Massey Comprehensive Cancer Center

Richmond, Virginia 23298

United States

Swedish Cancer Institute Edmonds

Edmonds, Washington 98026

United States

Swedish Cancer Institute Issaquah

Issaquah, Washington 98029

United States

Swedish Cancer Institute

Seattle, Washington 98104

United States

Fred Hutchinson Cancer Research Center

Seattle, Washington 98109

United States

William S. Middleton Memorial VA

Madison, Wisconsin 53705

United States

Institut Jules Bordet

Anderlecht, 1070

Belgium

Universitair Ziekenhuis Antwerpen

Edegem, 2650

Belgium

AZ Maria Middelares

Ghent, 9000

Belgium

Hopital de 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

Clinica de Hematologia e Oncologia Viver Ltda

Santa Maria, 97015 450

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

Arthur J E Child Comprehensive Cancer Centre

Calgary, Alberta T2N 5G2

Canada

Ottawa Hospital

Ottawa, Ontario K1H 8L6

Canada

Princess Margaret Cancer Centre

Toronto, Ontario M5G1X6

Canada

Centre de Recherche du CHUM

Montreal, Quebec H2X 0C1

Canada

Peking University First Hospital

Beijing, 100034

China

Beijing Friendship Hospital Capital Medical University

Beijing, 100050

China

Beijing Cancer Hospital

Beijing, 100142

China

Peking University Third Hospital

Beijing, 100191

China

The First Bethune Hospital of Jilin University

Changchun, 130021

China

Hunan Cancer hospital

Changsha, 410013

China

Sun Yat Sen University Cancer Center

Guangzhou, 510062

China

The Sixth Affiliated Hospital Sun Yat sen University

Guangzhou, 510655

China

Guangdong Provincial People's Hospital

Guangzhou, 519041

China

The First Affiliated Hospital Zhejiang University College of Medicine

Hangzhou, 310003

China

The Second Affiliated Hospital of Zhejiang University College of Medicine

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

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

Peking University Shenzhen Hospital

Shenzhen, 518036

China

West China Hospital of Sichuan University

Sichuan, 610044

China

First Hospital of Shanxi Medical University

Taiyuan, 030001

China

Tianjin Medical University Cancer Institute and Hospital

Tianjin, 300060

China

Hubei Cancer Hospital

Wuhan, 430079

China

Institut Sainte Catherine

Avignon, 84918

France

Hopital Claude Huriez

Lille, 59000

France

Hopital Prive Jean Mermoz

Lyon, 69008

France

Institut du Cancer de Montpellier

Montpellier, 34298

France

CHU Nantes

Nantes, 44000

France

Hopital Saint Antoine

Paris, 75571

France

Hopital Haut Leveque

Pessac, 33604

France

CHU De Poitiers

Poitiers, 86000

France

Gustave Roussy

Villejuif, 94805

France

Charite Universitatsmedizin Berlin Campus Virchow Klinikum

Berlin, 13353

Germany

Universitaetsklinikum Carl Gustav Carus TU Dresden

Dresden, 01307

Germany

Essen University Hospital

Essen, 45147

Germany

Krankenhaus NorthWest

Frankfurt am Main, 60488

Germany

Praxis fur interdisziplinare Onkologie & Hamatologie GbR

Freiburg im Breisgau, 79110

Germany

Asklepios Klinik Altona

Hamburg, 22763

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

Universitatsklinikum Ulm

Ulm, 89081

Germany

Semmelweis Egyetem

Budapest, 1082

Hungary

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

B P Poddar Hospital and Medical research Limited

Kolkata, 700053

India

Tata Memorial Hospital

Mumbai, 400012

India

Deenanath Mangeshkar Hospital and Research Centre

Pune, 411004

India

Mahamana Pandit Madan Mohan Malviya Cancer Centre

Varanasi, 221005

India

Yitzhak Shamir Medical Center

Beer Yaakov, 70300

Israel

Rambam Medical Center

Haifa, 3109601

Israel

Hadassah University Hospita Ein Kerem

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

Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori

Meldola, 47014

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

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

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 Canselor Tuanku Muhriz UKM

Cheras, 56000

Malaysia

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

National Cancer Institute

Putrajaya, 62250

Malaysia

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

Elisabeth-TweeSteden Ziekenhuis

Tilburg, 5022 GC

Netherlands

UMC Utrecht

Utrecht, 3584 CX

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, 02 781

Poland

Pan American Center for Oncology Trials LLC

Barrio Monacillos, 00935

Puerto Rico

Kyungpook National University Chilgok Hospital

Daegu, 41404

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 Marys Hospital

Seoul, 06591

South Korea

Hosp. de La Santa Creu I Sant Pau

Barcelona, 08025

Spain

Hosp Univ Vall D Hebron

Barcelona, 08035

Spain

Hosp. Gral. Univ. Gregorio Maranon

Madrid, 28007

Spain

Hosp. Univ. Ramon Y Cajal

Madrid, 28034

Spain

Hosp. Univ. 12 de Octubre

Madrid, 28041

Spain

Clinica Univ. de Navarra

Pamplona, 31008

Spain

Hosp. Virgen Del Rocio

Seville, 41013

Spain

Hosp. Clinico Univ. de Valencia

Valencia, 46010

Spain

Sahlgrenska University Hospital

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

Kaohsiung Chang Gung Memorial Hospital

Kaohsiung City, 83301

Taiwan

National Cheng Kung University Hospital

Tainan, 704

Taiwan

National Taiwan University Hospital

Taipei, 10043

Taiwan

Linkou Chang Gung Memorial Hospital

Taoyuan, 333

Taiwan

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)

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

Addenbrooke's Hospital

Cambridge, CB2 0QQ

United Kingdom

Western General Hospital

Edinburgh, EH4 2XU

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

Mount Vernon Cancer Centre

Northwood, HA6 2RN

United Kingdom

Royal Marsden Hospital (Sutton)

Sutton, SM2 5PT

United Kingdom