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A Randomized, Open-label Phase 3 Study of Amivantamab + FOLFIRI Versus Cetuximab/Bevacizumab + FOLFIRI in Participants With KRAS/NRAS and BRAF Wildtype Recurrent, Unresectable or Metastatic Colorectal Cancer Who Have Received Prior Chemotherapy

Primary Investigator
Krauss, John
Status
OPEN TO ACCRUAL
Phase
III
NCT Number
NCT06750094
UM Number
2025.013
Age Group
Adults
Management Group
CTSU - Oncology
Oncology Group
Gastrointestinal Oncology
ID (Protocol)
56280
Secondary Protocol No
HUM00267381
Scope
Unspecified
Sponsor Type
Industry
Disease Site
Colon
Rectum
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: 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
Exclusion Criteria
  •   * Has medical history of (noninfectious) interstitial lung disease (ILD) /pneumonitis/pulmonary fibrosis or has current ILD/pneumonitis/pulmonary fibrosis, or where suspected ILD/pneumonitis/pulmonary fibrosis cannot be ruled out by imaging at screening
  •   * Has known allergies, hypersensitivity, or intolerance to excipients of any of the following: amivantamab, cetuximab or bevacizumab or any component of FOLFIRI
  •   * Has a prior or concurrent second malignancy other than the disease under study or one whose natural history or treatment is unlikely to interfere with any study endpoints of safety or the efficacy of the study treatment(s)
  •   * Participant with known mismatch repair deficiency (dMMR)/ high microsatellite instability (MSI-H) status who has not received immunotherapy treatments
  •   * Participant with known human epidermal growth factor receptor 2 (HER2)- positive/amplified tumor
  •   * Has prior exposure to irinotecan, any agents that target epidermal growth factor receptor (EGFR) or mesenchymal epithelial transition (MET)