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)

NCT 06750094

Brief 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.

Intervention / Treatment

  • Biological: Amivantamab
  • Biological: Cetuximab
  • Biological: Bevacizumab
  • Drug: 5-fluorouracil
  • Drug: Leucovorin calcium/Levoleucovorin
  • Drug: Irinotecan

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
  • 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 RECIST v1.1
  • 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

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