Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at Santa Monica, California and other locations
Dates
study started
study ends around
Principal Investigator
by J. Randolph Hecht, MD
Headshot of J. Randolph Hecht
J. Randolph Hecht

Description

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.

Official Title

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

Keywords

Colorectal Neoplasms, Leucovorin, Bevacizumab, Cetuximab, Amivantamab-vmjw, Fluorouracil, Irinotecan, Calcium, Levoleucovorin, Amivantamab, 5-fluorouracil, Leucovorin calcium/Levoleucovorin, Amivantamab + FOLFIRI

Eligibility

You can join if…

Open to people ages 18 years and up

  • 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

You CAN'T join if...

  • 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)

Locations

  • UCLA accepting new patients
    Santa Monica California 90404 United States
  • Los Angeles Cancer Network accepting new patients
    Glendale California 91204 United States
  • USC Norris Comprehensive Cancer Center accepting new patients
    Los Angeles California 90033 United States
  • Torrance Memorial Physicians Network accepting new patients
    Torrance California 90505 United States
  • Cancer and Blood Specialty Clinic accepting new patients
    Los Alamitos California 90720 United States

Lead Scientist at UCLA

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Janssen Research & Development, LLC
Links
Sign up for this study
ID
NCT06750094
Phase
Phase 3 research study
Study Type
Interventional
Participants
Expecting 700 study participants
Last Updated