Last updated 11 days ago
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
700 patients around the world
Available in Puerto Rico, Brazil
Janssen Research & Development, LLC
5Research sites
700Patients around the world
This study is for people with
Colorectal cancer
Requirements for the patient
From 18 Years
All Gender
Medical requirements
- 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.
- 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).
Sites
Hospital de Câncer de Barretos - Fundação PIO XII
Recruiting
Centro de Pesquisas Clinicas da Fundacao Doutor Amaral Carvalho
Recruiting
AC Camargo Cancer Center
Recruiting
Hospital Santa Rita
Recruiting
Pan American Center for Oncology Trials
Recruiting
StudyOrigAMI-3
SponsorJanssen Research & Development, LLC
Study typeInterventional
Conditions
Colorectal cancer
Requirements
From 18 YearsAll Gender
Unique study IDclinicaltrials.gov
NCT06750094
