TrialPath
← Back to searchRecruiting

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

NCT06750094 · Janssen Research & Development, LLC
In plain English

Click the button to translate this study into plain language — what it is, who qualifies, and what participation looks like.

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
About this study
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
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 target: 700 participants
Allocation: randomized
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2024-12-12
Estimated completion: 2029-04-13
Last updated: 2026-04-13
Interventions
Biological: AmivantamabBiological: CetuximabBiological: BevacizumabDrug: 5-fluorouracilDrug: Leucovorin calcium/LevoleucovorinDrug: Irinotecan
Primary outcomes
  • Progression-Free Survival (PFS) as Assessed by Blinded Independent Central Review (BICR) (Up to 2 years 1 month)
  • Overall Survival (OS) (Up to 4 years 4 months)
Sponsor
Janssen Research & Development, LLC · industry
Contacts & investigators
ContactStudy Contact · contact · Participate-In-This-Study1@its.jnj.com · 844-434-4210
InvestigatorJanssen Research & Development, LLC Clinical Trial · study_director, Janssen Research & Development, LLC
All locations (234)
Ironwood Cancer and Research CenterRecruiting
Chandler, Arizona, United States
Banner MD Anderson Cancer CenterRecruiting
Gilbert, Arizona, United States
Arizona Oncology Associates PC NAHOACompleted
Prescott, Arizona, United States
St. Bernard's Medical CenterRecruiting
Jonesboro, Arkansas, United States
Highlands Oncology GroupRecruiting
Springdale, Arkansas, United States
CBCC Global ResearchRecruiting
Bakersfield, California, United States
Los Angeles Cancer NetworkRecruiting
Glendale, California, United States
Cancer and Blood Specialty ClinicRecruiting
Los Alamitos, California, United States
USC Norris Comprehensive Cancer CenterRecruiting
Los Angeles, California, United States
UCLARecruiting
Santa Monica, California, United States
Providence Medical FoundationRecruiting
Santa Rosa, California, United States
Torrance Memorial Physicians NetworkRecruiting
Torrance, California, United States
University of Colorado Denver Anschultz Medical CampusRecruiting
Aurora, Colorado, United States
Rocky Mountain Cancer CentersRecruiting
Denver, Colorado, United States
Eastern Connecticut Hematology & Oncology Assoc.Recruiting
Norwich, Connecticut, United States
Florida Cancer Specialists SouthRecruiting
Fort Myers, Florida, United States
Mount Sinai Medical Center CampusRecruiting
Miami Beach, Florida, United States
AdventHealth Cancer InstituteRecruiting
Orlando, Florida, United States
Florida Cancer Specialists North RegionRecruiting
St. Petersburg, Florida, United States
Florida Cancer Specialists EastRecruiting
West Palm Beach, Florida, United States
University Cancer And Blood Center LLCRecruiting
Athens, Georgia, United States
Grady Memorial HospitalRecruiting
Atlanta, Georgia, United States
Piedmont Cancer InstituteRecruiting
Atlanta, Georgia, United States
Winship Cancer Institute Emory UniversityRecruiting
Atlanta, Georgia, United States
Illinois CancerCareRecruiting
Peoria, Illinois, United States
Mission Cancer BloodRecruiting
Waukee, Iowa, United States
Cancer Center of KansasRecruiting
Wichita, Kansas, United States
Mary Bird Perkins Cancer CenterRecruiting
Baton Rouge, Louisiana, United States
MedStar Franklin Square Medical CenterRecruiting
Baltimore, Maryland, United States
University of Michigan Rogel Cancer CenterRecruiting
Ann Arbor, Michigan, United States
Henry Ford HospitalRecruiting
Detroit, Michigan, United States
Cancer And Hematology Centers of Western Michigan PCRecruiting
Grand Rapids, Michigan, United States
Hattiesburg ClinicRecruiting
Hattiesburg, Mississippi, United States
Washington University School Of MedicineRecruiting
St Louis, Missouri, United States
Nebraska Cancer SpecialistsRecruiting
Omaha, Nebraska, United States
Astera Cancer CareRecruiting
East Brunswick, New Jersey, United States
Perlmutter Cancer Center at NYU Long IslandRecruiting
Mineola, New York, United States
NYU Langone Medical Center NYU Hematology AssociatesRecruiting
New York, New York, United States
New York Cancer and Blood SpecialistsRecruiting
Shirley, New York, United States
Montefiore Einstein Comprehensive Cancer CenterRecruiting
The Bronx, New York, United States
Gabrail Cancer CenterRecruiting
Canton, Ohio, United States
University Hospital of ClevelandRecruiting
Cleveland, Ohio, United States
Oregon Health And Science UniversityRecruiting
Portland, Oregon, United States
Alliance Cancer Specialists at Main LineRecruiting
Penn Wynne, Pennsylvania, United States
Thomas Jefferson UniversityRecruiting
Philadelphia, Pennsylvania, United States
Fox Chase Cancer CenterRecruiting
Philadelphia, Pennsylvania, United States
University Of Pittsburgh Medical Center UPMC Hillman Cancer CenterRecruiting
Pittsburgh, Pennsylvania, United States
Tennessee Oncology ChattanoogaRecruiting
Chattanooga, Tennessee, United States
SCRI Oncology PartnersRecruiting
Nashville, Tennessee, United States
Tennessee OncologyRecruiting
Nashville, Tennessee, United States
Vanderbilt University Medical CenterRecruiting
Nashville, Tennessee, United States
Texas Oncology West TexasRecruiting
Abilene, Texas, United States
Texas Oncology DFWRecruiting
Dallas, Texas, United States
UT Southwestern Medical CenterRecruiting
Dallas, Texas, United States
MD Anderson Cancer CenterRecruiting
Houston, Texas, United States
Baylor Scott & White Medical CenterRecruiting
Round Rock, Texas, United States
Texas Oncology - San AntonioRecruiting
San Antonio, Texas, United States
Scott And White Memorial HospitalRecruiting
Temple, Texas, United States
UT Health East Texas HOPE Cancer CenterRecruiting
Tyler, Texas, United States
Virginia Cancer SpecialistsRecruiting
Arlington, Virginia, United States
Richmond VA Medical CenterRecruiting
Richmond, Virginia, United States
VCU Massey Comprehensive Cancer CenterRecruiting
Richmond, Virginia, United States
Providence Regional Cancer SystemRecruiting
Lacey, Washington, United States
Fred Hutchinson Cancer Research CenterRecruiting
Seattle, Washington, United States
Medical College Of WisconsinRecruiting
Milwaukee, Wisconsin, United States
Concord HospitalRecruiting
Concord, Australia
Warringal Private HospitalRecruiting
Heidelberg, Australia
Queen Elizabeth HospitalRecruiting
South Woodville, Australia
Western Health Sunshine HospitalRecruiting
St Albans, Australia
Institut Jules BordetRecruiting
Anderlecht, Belgium
UZ AntwerpenRecruiting
Edegem, Belgium
AZ Maria MiddelaresRecruiting
Ghent, Belgium
JolimontRecruiting
Haine Saint Paul La Louviere, Belgium
Az GroeningeRecruiting
Kortrijk, Belgium
Universitair Ziekenhuis LeuvenRecruiting
Leuven, Belgium
Centre Hospitalier Universitaire de Liege Domaine Universitaire du Sart TilmanRecruiting
Liège, Belgium
Fundacao Pio XIIRecruiting
Barretos, Brazil
Fundacao Universidade de Caxias do SulRecruiting
Caxias do Sul, Brazil
Fundacao Doutor Amaral CarvalhoRecruiting
Jaú, Brazil
Hospital Nossa Senhora da Conceicao S ARecruiting
Porto Alegre, Brazil
Hospital Santa Izabel Santa Casa de Misericordia da BahiaRecruiting
Salvador, Brazil
Fundacao Faculdade Regional De Medicina S Jose Rio Preto Hospital De BaseRecruiting
São José do Rio Preto, Brazil
Fundacao Faculdade de Medicina - Instituto do Cancer do Estado de Sao PauloRecruiting
São Paulo, Brazil
Fundacao Antonio Prudente A C Camargo Cancer CenterRecruiting
São Paulo, Brazil
Sociedade Beneficente Israelita Brasileira Hospital Albert EinsteinRecruiting
São Paulo, Brazil
Associacao Feminina de Educacao e Combate ao Cancer Hospital Santa Rita de CassiaRecruiting
Vitória, Brazil
Peking University First HospitalRecruiting
Beijing, China
Beijing Friendship Hospital Capital Medical UniversityRecruiting
Beijing, China
Beijing Cancer HospitalRecruiting
Beijing, China
The First Bethune Hospital of Jilin UniversityRecruiting
Changchun, China
Hunan Cancer hospitalRecruiting
Changsha, China
West China Hospital of Sichuan UniversityRecruiting
Chengdu, China
Ganzhou Cancer HospitalRecruiting
Ganzhou, China
Sun Yat Sen University Cancer CenterRecruiting
Guangzhou, China
The Sixth Affiliated Hospital Sun Yat sen UniversityRecruiting
Guangzhou, China
Guangdong Provincial People's HospitalRecruiting
Guangzhou, China
The Second Affiliated Hospital of Zhejiang UniversityRecruiting
Hangzhou, China
Zhejiang Cancer HospitalRecruiting
Hangzhou, China
Harbin medical university cancer hospitalRecruiting
Harbin, China
Huizhou Central People's HospitalRecruiting
Huizhou, China
Gansu Provincial Cancer HospitalRecruiting
Lanzhou, China
The First Affiliated Hospital of NanChang UniversityRecruiting
Nanchang, China
Fudan University Shanghai Cancer CenterRecruiting
Shanghai, China
Liaoning Cancer Hospital and InstituteRecruiting
Shenyang, China
Tianjin Medical University Cancer Institute and HospitalRecruiting
Tianjin, China
Hubei Cancer HospitalRecruiting
Wuhan, China
Institut Sainte CatherineRecruiting
Avignon, France
Hopital Haut LevequeRecruiting
Pessac, France
CHU De PoitiersRecruiting
Poitiers, France
Charite Universitatsmedizin Berlin Campus Virchow KlinikumRecruiting
Berlin, Germany
Krankenhaus NorthWestRecruiting
Frankfurt am Main, Germany
National Center for Tumor Diseases NCTRecruiting
Heidelberg, Germany
Universitatsmedizin der Johannes Gutenberg Universitat MainzRecruiting
Mainz, Germany
Klinikum der Universitaet MuenchenRecruiting
Munich, Germany
Queen Mary HospitalRecruiting
Hong Kong, Hong Kong
Prince Of Wales HospitalRecruiting
Shatin, Hong Kong
Markhot Ferenc Oktatokorhaz es RendelointezetCompleted
Eger, Hungary
Pecsi TudomanyegyetemCompleted
Pécs, Hungary
Szegedi TudomanyegyetemCompleted
Szeged, Hungary
Rajiv Gandhi Cancer Institute and Research CentreRecruiting
Delhi, India
Asian Institute Of GastroenterologyRecruiting
Hyderabad, India
B P Poddar Hospital and Medical research LimitedRecruiting
Kolkata, India
Tata Memorial HospitalRecruiting
Mumbai, India
Safdarjung HospitalRecruiting
New Delhi, India
Deenanath Mangeshkar Hospital and Research CentreRecruiting
Pune, India
Mahamana Pandit Madan Mohan Malviya Cancer CentreRecruiting
Varanasi, India
Christian medicalRecruiting
Vellore, India
Yitzhak Shamir Medical CenterRecruiting
Beer Yaakov, Israel
Rambam Medical CenterRecruiting
Haifa, Israel
Hadassah Medical CenterRecruiting
Jerusalem, Israel
Rabin Medical CenterRecruiting
Petah Tikva, Israel
Sheba Medical CenterRecruiting
Ramat Gan, Israel
Tel Aviv Sourasky Medical CenterRecruiting
Tel Aviv, Israel
Assuta MCRecruiting
Tel Aviv, Israel
Istituto Dei Tumori Di MilanoRecruiting
Milan, Italy
Istituto Oncologico Veneto - IRCCSRecruiting
Padova, Italy
Azienda Ospedaliero Universitaria PisanaRecruiting
Pisa, Italy
Istituto Clinico HumanitasRecruiting
Rozzano, Italy
Azienda Sanitaria Universitaria Friuli Centrale ASU FCRecruiting
Udine, Italy
Chiba Cancer CenterRecruiting
Chiba, Japan
National Cancer Center HospitalRecruiting
Chūōku, Japan
National Cancer Center Hospital EastRecruiting
Kashiwa, Japan
Aichi Cancer CenterRecruiting
Nagoya, Japan
National Hospital Organization Osaka National HospitalRecruiting
Osaka, Japan
Osaka International Cancer InstituteRecruiting
Osaka, Japan
Kindai University HospitalRecruiting
Sakai, Japan
Shizuoka Cancer CenterRecruiting
Shizuoka, Japan
The University of Osaka HospitalRecruiting
Suita, Japan
The Cancer Institute Hospital of JFCRRecruiting
Tokyo, Japan
Hospital Pulau PinangRecruiting
George Town, Malaysia
Hospital Raja Permaisuri BainunRecruiting
Ipoh, Malaysia
Hospital Kuala LumpurRecruiting
Kuala Lumpur, Malaysia
University Malaya Medical CentreRecruiting
Kuala Lumpur, Malaysia
Hospital Umum SarawakRecruiting
Kuching, Malaysia
Institut Kanser Negara Clinical Research CenterRecruiting
Putrajaya, Malaysia
Centro Oncologico de ChihuahuaRecruiting
Chihuahua City, Mexico
Actualidad Basada En La Investigacion Del CancerRecruiting
Guadalajara, Mexico
Centro Oncologico Personalizado Cope S De R L De C VRecruiting
Mexico City, Mexico
Instituto Nacional de CancerologiaRecruiting
Mexico City, Mexico
Hospital Universitario Dr Jose Eleuterio GonzalezRecruiting
Monterrey, Mexico
OncocenterRecruiting
Puebla City, Mexico
Cuidados OncologicosRecruiting
Querétaro, Mexico
Health Pharma Queretaro SA de CVRecruiting
Querétaro, Mexico
COI Centro Oncologico Internacional TijuanaRecruiting
Tijuana, Mexico
Meander Medisch CentrumRecruiting
Amersfoort, Netherlands
Antoni van LeeuwenhoekRecruiting
Amsterdam, Netherlands
Radboud University Medical CenterRecruiting
Nijmegen, Netherlands
Erasmus MCRecruiting
Rotterdam, Netherlands
ETZ TweeStedenRecruiting
Tilburg, Netherlands
Bialostockie Centrum Onkologii im Marii Sklodowskiej Curie w BialymstokuRecruiting
Bialystok, Poland
Wojewodzki Szpital SpecjalistycznyRecruiting
Biała Podlaska, Poland
Szpital Specjalistyczny w Brzozowie Podkarpacki Osrodek Onkologiczny im Ks B MarkiewiczaRecruiting
Brzozów, Poland
Uniwersyteckie Centrum KliniczneRecruiting
Gdansk, Poland
Narodowy Instytut Onkologii im Marii Sklodowskiej Curie Panstwowy Instytut BadawczyOddz w GliwicachRecruiting
Gliwice, Poland
Instytut Centrum Zdrowia Matki PolkiRecruiting
Lodz, Poland
Szpital Kliniczny MSWiA z WMCORecruiting
Olsztyn, Poland
SPZOZ Opolskie Centrum Onkologii im. Prof. Tadeusza KoszarowskiegoRecruiting
Opole, Poland
Narodowy Instytut Onkologii im Marii Sklodowskiej Curie Panstwowy Instytut BadawczyRecruiting
Warsaw, Poland
Pan American Center for Oncology Trials LLCRecruiting
San Juan, Puerto Rico
Centrul Medical Unirea SRLRecruiting
Brasov, Romania
Spitalul Memorial BaneasaRecruiting
Bucharest, Romania
Ponderas Academic HospitalRecruiting
Bucharest, Romania
Neolife Medical Center BucharestRecruiting
Bucharest, Romania
Institutul Oncologic 'Prof Dr. Ion Chiricuta' Cluj-NapocaRecruiting
Cluj-Napoca, Romania
Clinica de Oncologie Sf NectarieRecruiting
Craiova, Romania
Institutul Regional de Oncologie IasiRecruiting
Iași, Romania
Pelican Impex SRLRecruiting
Oradea, Romania
Kyungpook National University Chilgok HospitalRecruiting
Daegu, South Korea
Korea University Anam HospitalRecruiting
Seoul, South Korea
Seoul National University HospitalRecruiting
Seoul, South Korea
Severance Hospital Yonsei University Health SystemRecruiting
Seoul, South Korea
Asan Medical CenterRecruiting
Seoul, South Korea
Samsung Medical CenterRecruiting
Seoul, South Korea
The Catholic University of Korea Seoul St Mary s HospitalRecruiting
Seoul, South Korea
Hosp. de La Santa Creu I Sant PauRecruiting
Barcelona, Spain
Hosp Univ Vall D HebronRecruiting
Barcelona, Spain
Hosp. Gral. Univ. Gregorio MaranonRecruiting
Madrid, Spain
Hosp. Univ. Ramon Y CajalRecruiting
Madrid, Spain
Hosp. Univ. 12 de OctubreRecruiting
Madrid, Spain
Clinica Univ. de NavarraRecruiting
Pamplona, Spain
Hosp. Virgen Del RocioRecruiting
Seville, Spain
Hosp. Clinico Univ. de ValenciaRecruiting
Valencia, Spain
Sahlgrenska UniversitetssjukhusetRecruiting
Gothenburg, Sweden
Skanes universitetssjukhusRecruiting
Lund, Sweden
SodersjukhusetRecruiting
Stockholm, Sweden
Karolinska UniversitetssjukhusetRecruiting
Stockholm, Sweden
Uppsala UniversityRecruiting
Uppsala, Sweden
Kaohsiung Medical University Chung Ho Memorial HospitalRecruiting
Kaohsiung City, Taiwan
Chang Gung Memorial HospitalRecruiting
Kaohsiung City, Taiwan
Taichung Veterans General HospitalRecruiting
Taichung, Taiwan
National Cheng Kung University HospitalRecruiting
Tainan, Taiwan
National Taiwan University HospitalRecruiting
Taipei, Taiwan
Taipei Veterans General HospitalRecruiting
Taipei, Taiwan
Linkou Chang Gung Memorial HospitalRecruiting
Taoyuan District, Taiwan
Ramathibodi HospitalRecruiting
Bangkok, Thailand
Siriraj HospitalRecruiting
Bangkok, Thailand
Chiang Mai UniversityRecruiting
Chiang Mai, Thailand
Songklanagarind hospitalRecruiting
Songkhla, Thailand
Adana City HospitalRecruiting
Adana, Turkey (Türkiye)
Gulhane Egitim ve Arastirma HastanesiRecruiting
Ankara, Turkey (Türkiye)
Dr Abdurrahman Yurtaslan Oncology Training and Research HospitalRecruiting
Ankara, Turkey (Türkiye)
Gazi Universitesi HastanesiRecruiting
Ankara, Turkey (Türkiye)
Ankara Bilkent Sehir HastanesiRecruiting
Ankara, Turkey (Türkiye)
Bakirkoy Training and Research HospitalRecruiting
Istanbul, Turkey (Türkiye)
Marmara Universitesi Pendik Egitim ve Arastirma HastanesiRecruiting
Istanbul, Turkey (Türkiye)
Necmettin Erbakan Universitesi Tip Fakultesi HastanesiRecruiting
Konya, Turkey (Türkiye)
Sakarya University Training and Research HospitalRecruiting
Sakarya, Turkey (Türkiye)
Birmingham Heartlands HospitalRecruiting
Birmingham, United Kingdom
Castle Hill HospitalRecruiting
Hull, United Kingdom
St James University HospitalRecruiting
Leeds, United Kingdom
St Bartholomew's HospitalRecruiting
London, United Kingdom
University College HospitalRecruiting
London, United Kingdom
Royal Marsden HospitalRecruiting
London, United Kingdom
Mount Vernon Cancer CentreRecruiting
Northwood, United Kingdom
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 · TrialPath