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 (OrigAMI-2)
Last Updated February 14, 2025
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61186372COR3001
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) 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.
CONDITIONS
- Colorectal Neoplasms
ELIGIBILITY
Inclusion Criteria:
* Have histologically or cytologically confirmed adenocarcinoma of the left-sided colorectal cancer. Participants must have unresectable or metastatic disease
* Be diagnosed to have Kirsten rat sarcoma viral oncogene (KRAS), neuroblastoma RAS viral oncogene ho
DETAILS
LOCATIONS
| Country (5) | City or Province (23) | Status |
| United States | Los Alamitos Cancer and Blood Specialty Clinic |
RECRUITING
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| United States | Santa Rosa Providence Medical Foundation |
RECRUITING
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| United States | Baltimore MedStar Franklin Square Medical Center |
RECRUITING
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| United States | Omaha Nebraska Cancer Specialists Midwest Cancer Center |
RECRUITING
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| United States | Las Vegas Comprehensive Cancer Centers of Nevada |
RECRUITING
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| United States | Temple Baylor Scott and White Health |
RECRUITING
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| Belgium | Kortrijk Az Groeninge |
RECRUITING
|
| Japan | Chuo Ku National Cancer Center Hospital |
RECRUITING
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| Japan | Osaka-Shi National Hospital Organization Osaka National Hospital |
RECRUITING
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| Japan | Suita Osaka University Hospital |
RECRUITING
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| Japan | Tokyo The Cancer Institute Hospital of JFCR |
RECRUITING
|
| Malaysia | Cheras Hospital Canselor Tuanku Muhriz UKM |
RECRUITING
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| Malaysia | Georgetown Hospital Pulau Pinang |
RECRUITING
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| Malaysia | Ipoh Hospital Raja Permaisuri Bainun |
RECRUITING
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| Malaysia | Kuala Lumpur Hospital Kuala Lumpur |
RECRUITING
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| Malaysia | Kuala Lumpur University Malaya Medical Centre |
RECRUITING
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| Malaysia | Kuching Hospital Umum Sarawak |
RECRUITING
|
| Malaysia | Putrajaya National Cancer Institute |
RECRUITING
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| Taiwan | Kaohsiung City Chang Kung Memorial Hospital |
RECRUITING
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| Taiwan | Kaohsiung Kaohsiung Medical University Chung Ho Memorial Hospital |
RECRUITING
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| Taiwan | Tainan National Cheng Kung University Hospital |
RECRUITING
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| Taiwan | Taipei National Taiwan University Hospital |
RECRUITING
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| Taiwan | Taoyuan Linkou Chang Gung Memorial Hospital |
RECRUITING
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33.80307, -118.07256
38.44047, -122.71443
39.29038, -76.61219
41.25626, -95.94043
36.17497, -115.13722
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50.82803, 3.26487
35.57779, 139.71685
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