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 (OrigAMI-3)
Last Updated March 11, 2025
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61186372COR3002
OVERVIEW
-
Sexes Eligible for Study
all -
Age
years -
Phase
phase 33 -
Sites
Sites -
Status
Recruiting
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
ELIGIBILITY
Inclusion Criteria:
* Have histologically or cytologically confirmed adenocarcinoma of the colon or rectum. Participants must have recurrent, unresectable or metastatic disease
* Be diagnosed to have KRAS, NRAS, and BRAF wild-type (WT) tumor as determined by local testing
* Mu
DETAILS
LOCATIONS
Country (23) | City or Province (103) | Status |
United States | Los Alamitos Cancer and Blood Specialty Clinic |
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United States | Santa Rosa Providence Medical Foundation |
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United States | Baltimore MedStar Franklin Square Medical Center |
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Australia | Concord Concord Hospital |
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Australia | Heidelberg Warringal Private Hospital |
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Australia | South Woodville Queen Elizabeth Hospital |
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Australia | St Albans Western Health Sunshine Hospital |
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Malaysia | Kuala Lumpur University Malaya Medical Centre |
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Malaysia | Kuching Hospital Umum Sarawak |
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Puerto Rico | Barrio Monacillos Pan American Center for Oncology Trials LLC |
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Taiwan | Kaohsiung Kaohsiung Medical University Chung Ho Memorial Hospital |
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Taiwan | Taipei National Taiwan University Hospital |
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Taiwan | Taipei Taipei Veterans General Hospital |
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Taiwan | Taoyuan Linkou Chang Gung Memorial Hospital |
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United States | Orlando AdventHealth Cancer Institute |
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United States | Grand Rapids Cancer And Hematology Centers of Western Michigan PC |
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United States | Hattiesburg Hattiesburg Clinic |
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United States | Omaha Nebraska Cancer Specialists |
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United States | Houston MD Anderson Cancer Center |
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United States | Lacey Providence Regional Cancer System |
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Belgium | Anderlecht Institut Jules Bordet |
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Belgium | Edegem UZ Antwerpen |
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Belgium | Gent AZ Maria Middelares |
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Belgium | Haine Saint Paul La Louviere Jolimont |
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Belgium | Kortrijk Az Groeninge |
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Belgium | Leuven Universitair Ziekenhuis Leuven |
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Brazil | Barretos Fundacao Pio XII |
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Brazil | Jau Fundacao Doutor Amaral Carvalho |
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Brazil | Sao Paulo Fundacao Antonio Prudente A C Camargo Cancer Center |
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Brazil | Vitoria Associacao Feminina de Educacao e Combate ao Cancer Hospital Santa Rita de Cassia |
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China | Beijing Peking University First Hospital |
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China | Beijing Beijing Cancer Hospital |
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China | Chengdu West China Hospital of Sichuan University |
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China | Ganzhou Ganzhou Cancer Hospital |
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China | Guangzhou Sun Yat-Sen University Cancer Center |
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China | Hangzhou The Second Affiliated Hospital of Zhejiang University |
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China | Huizhou Huizhou Central People's Hospital |
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China | Wuhan Hubei Cancer Hospital |
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France | Avignon Cedex 9 Institut Sainte Catherine |
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Germany | Berlin Charite Universitatsmedizin Berlin Campus Virchow Klinikum |
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Germany | Munich Klinikum der Universitaet Muenchen |
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Hong Kong | Shatin Prince Of Wales Hospital |
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India | Delhi Rajiv Gandhi Cancer Institute and Research Centre |
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India | Kolkata B P Poddar Hospital and Medical research Limited |
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India | Pune Deenanath Mangeshkar Hospital and Research Centre |
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Israel | Beer Yaakov Yitzhak Shamir Medical Center |
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Israel | Haifa Rambam Medical Center |
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Israel | Jerusalem Hadassah Medical Center |
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Israel | Petach Tikva Rabin Medical Center |
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Israel | Ramat Gan Sheba Medical Center |
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Israel | Tel Aviv Yafo Tel Aviv Sourasky Medical Center |
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Israel | Tel Aviv Assuta MC |
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Italy | Pisa Azienda Ospedaliero Universitaria Pisana |
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Japan | Chiba Chiba Cancer Center |
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Japan | Chuo Ku National Cancer Center Hospital |
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Japan | Nagoya Shi Aichi Cancer Center |
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Japan | Osaka City Osaka International Cancer Institute |
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Japan | Osaka Sayama shi Kindai University Hospital |
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Japan | Osaka-Shi National Hospital Organization Osaka National Hospital |
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Japan | Suita-shi Osaka University Hospital |
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Japan | Tokyo The Cancer Institute Hospital of JFCR |
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South Korea | Daegu Kyungpook National University Chilgok Hospital |
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South Korea | Seoul Korea University Anam Hospital |
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South Korea | Seoul Seoul National University Hospital |
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South Korea | Seoul Severance Hospital Yonsei University Health System |
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South Korea | Seoul Asan Medical Center |
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South Korea | Seoul Samsung Medical Center |
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South Korea | Seoul The Catholic University of Korea Seoul St Mary s Hospital |
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Malaysia | Georgetown Hospital Pulau Pinang |
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Malaysia | Ipoh Hospital Raja Permaisuri Bainun |
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Malaysia | Kuala Lumpur Hospital Kuala Lumpur |
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Malaysia | Putrajaya Institut Kanser Negara Clinical Research Center |
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Netherlands | Amersfoort Meander Medisch Centrum |
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Netherlands | Nijmegen Radboud University Medical Center |
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Netherlands | Tilburg ETZ TweeSteden |
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Poland | Brzozow Szpital Specjalistyczny w Brzozowie Podkarpacki Osrodek Onkologiczny im Ks B Markiewicza |
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Poland | Gdansk Uniwersyteckie Centrum Kliniczne |
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Poland | Gliwice Narodowy Instytut Onkologii im Marii Sklodowskiej Curie Panstwowy Instytut BadawczyOddz w Gliwicach |
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Poland | Lodz Instytut Centrum Zdrowia Matki Polki |
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Poland | Olsztyn SPZOZ Ministerstwa Spraw Wewnetrznych z Warminsko Mazurskim Centrum Onkologii w Olsztynie |
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Poland | Opole SPZOZ Opolskie Centrum Onkologii im. Prof. Tadeusza Koszarowskiego |
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Poland | Warszawa Narodowy Instytut Onkologii im Marii Sklodowskiej Curie Panstwowy Instytut Badawczy |
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Spain | Barcelona Hosp. de La Santa Creu I Sant Pau |
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Spain | Barcelona Hosp Univ Vall D Hebron |
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Spain | Madrid Hosp. Univ. Ramon Y Cajal |
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Spain | Pamplona Clinica Univ. de Navarra |
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Spain | Sevilla Hosp. Virgen Del Rocio |
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Spain | Valencia Hosp. Clinico Univ. de Valencia |
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Sweden | Gothenburg Sahlgrenska Universitetssjukhuset |
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Sweden | Lund Skanes universitetssjukhus |
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Sweden | Stockholm Sodersjukhuset |
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Sweden | Stockholm Karolinska Universitetssjukhuset |
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Sweden | Uppsala Uppsala University |
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Taiwan | Kaohsiung City Chang Gung Memorial Hospital |
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Taiwan | Taichung Taichung Veterans General Hospital |
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Taiwan | Tainan National Cheng Kung University Hospital |
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Thailand | Bangkok Ramathibodi Hospital |
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Thailand | Bangkok Siriraj Hospital |
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Thailand | Chiang Mai Chiang Mai University |
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Thailand | Songkhla Songklanagarind hospital |
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Türkiye | Ankara Gazi University Hospital |
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Türkiye | Konya Necmettin Erbakan University Meram Medical Faculty |
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United Kingdom | London St Bartholomew's Hospital |
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