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
Janssen Research & Development, LLC
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
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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 fro…
Interventions
- BiologicalAmivantamab
Amivantamab will be administered.
- BiologicalCetuximab
Cetuximab will be administered.
- BiologicalBevacizumab
Bevacizumab will be administered.
- Drug5-fluorouracil
5-fluorouracil will be administered as chemotherapy regimen.
- DrugLeucovorin calcium/Levoleucovorin
Leucovorin calcium/Levoleucovorin will be administered as chemotherapy regimen.
- DrugIrinotecan
Irinotecan will be administered as chemotherapy regimen.
Locations (241)
- Ironwood Cancer and Research CenterChandler, Arizona
- Banner MD Anderson Cancer CenterGilbert, Arizona
- Arizona Oncology Associates PC NAHOAPrescott, Arizona
- St. Bernard's Medical CenterJonesboro, Arkansas
- Highlands Oncology GroupSpringdale, Arkansas
- CBCC Global ResearchBakersfield, California