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

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, unresectabl

Trial Details

NCT ID
NCT06750094
Phase
PHASE3
Sponsor
Janssen Research & Development, LLC
Status
RECRUITING
Cancer Type
Colorectal Cancer
Interventions
  • Amivantamab
  • Cetuximab
  • Bevacizumab
  • 5-fluorouracil
  • Leucovorin calcium/Levoleucovorin
  • Irinotecan
Locations (sample)
  • Chandler, Arizona, United States|33.30616,-111.84125
  • Gilbert, Arizona, United States|33.35283,-111.78903
  • Prescott, Arizona, United States|34.54002,-112.4685
  • Jonesboro, Arkansas, United States|35.8423,-90.70428
  • Springdale, Arkansas, United States|36.18674,-94.12881

Key Eligibility Criteria

  • Have histologically or cytologically confirmed adenocarcinoma of the colon or rectum. Participants must have recurrent, unresectable or metastatic …
  • Determined to have kirsten rat sarcoma viral oncogene/neuroblastoma RAS viral oncogene homolog (KRAS/NRAS), G12, G13 and v-raf murine sarcoma viral…
  • 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

For full eligibility, visit ClinicalTrials.gov.

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