OrigAMI-3
Research type
Research Study
Full title
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
IRAS ID
1010712
Contact name
Sue Linnington
Contact email
Sponsor organisation
Janssen-Cilag International NV
Eudract number
2024-513853-66
ISRCTN Number
ISRCTN39913423
Research summary
This is a randomised, open-label, active-controlled, parallel-group, multicentre, interventional, Phase 3 study of amivantamab and standard of care chemotherapy (FOLFORI) compared with cetuximab or bevacizumab and FOLFIRI in participants who have recurrent, (unable to be removed with surgery) or metastatic (cancer that has spread from its original site) colorectal cancer (CRC) that lack mutations in genes called KRAS/NRAS and BRAF WT.
Despite recent advances in the treatment of metastatic CRC, patients continue to experience significant morbidity and mortality, underscoring the need to improve therapeutic approaches. The purpose of this study is to compare the efficacy (effectiveness) and safety of amivantamab and FOLFORI against cetuximab or bevacizumab and FOLFORI.
Participants will be randomised equally (1:1) to one of two study arms:
- Arm A: Amivantamab and FOLFORI.
- Arm B: Cetuximab or bevacizumab and FOLFORI.The study will consist of a Screening Period of up to 28 days, a Treatment Period consisting of 28-day treatment cycles, an End-of-Treatment (EoT) visit 30 days after the final study dose, and a Follow-up Period with visits/calls every 12 weeks.
Amivantamab is injected under the skin (subcutaneously) every week for the first treatment cycle, and then once every 2 weeks thereafter. Cetuximab will be administered through a vein in the arm (intravenously) either weekly or biweekly, depending on local practice. Bevacizumab will be delivered intravenously every 2 weeks. Chemotherapy (FOLFORI) will be delivered as per standard care.
REC name
South Central - Hampshire B Research Ethics Committee
REC reference
24/SC/0314
Date of REC Opinion
5 Nov 2024
REC opinion
Further Information Favourable Opinion