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
Recruiting · NCT06750094 · Interventional (participants receive a specific treatment) · Lead sponsor: Janssen Research & Development, LLC
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 3
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- Have histologically or cytologically confirmed adenocarcinoma of the colon or rectum. Participants must have recurrent, unresectable or metastatic disease
- Determined to have kirsten rat sarcoma viral oncogene/neuroblastoma RAS viral oncogene homolog (KRAS/NRAS), G12, G13 and v-raf murine sarcoma viral oncogene homolog B (BRAF) V600X (X represents any single amino acid change from the original amino acid) wild type status by local and/or central next-generation sequencing (NGS) 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 response evaluation criteria in solid tumors (RECIST) version (v) 1.1
- 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. Participants can receive anti-VEGF as prior 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 likely 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)
Where it is running
60 locations listed across 27 US states.
- Ironwood Cancer and Research Center - Chandler, Arizona, United States
- Banner MD Anderson Cancer Center - Gilbert, Arizona, United States
- Arizona Oncology Associates PC NAHOA - Prescott, Arizona, United States
- St. Bernard's Medical Center - Jonesboro, Arkansas, United States
- Highlands Oncology Group - Springdale, Arkansas, United States
- CBCC Global Research - Bakersfield, California, United States
- Los Angeles Cancer Network - Glendale, California, United States
- Cancer and Blood Specialty Clinic - Los Alamitos, California, United States
- USC Norris Comprehensive Cancer Center - Los Angeles, California, United States
- UCLA - Santa Monica, California, United States
- Providence Medical Foundation - Santa Rosa, California, United States
- Torrance Memorial Physicians Network - Torrance, California, United States
- University of Colorado Denver Anschultz Medical Campus - Aurora, Colorado, United States
- Rocky Mountain Cancer Centers - Denver, Colorado, United States
- Eastern Connecticut Hematology & Oncology Assoc. - Norwich, Connecticut, United States
- Florida Cancer Specialists South - Fort Myers, Florida, United States
- Mount Sinai Medical Center Campus - Miami Beach, Florida, United States
- AdventHealth Cancer Institute - Orlando, Florida, United States
- Florida Cancer Specialists North Region - St. Petersburg, Florida, United States
- Florida Cancer Specialists East - West Palm Beach, Florida, United States
- University Cancer And Blood Center LLC - Athens, Georgia, United States
- Grady Memorial Hospital - Atlanta, Georgia, United States
- Piedmont Cancer Institute - Atlanta, Georgia, United States
- Winship Cancer Institute Emory University - Atlanta, Georgia, United States
- Illinois Cancer Specialists - Arlington Heights, Illinois, United States
- Illinois CancerCare - Peoria, Illinois, United States
- Franciscan Health - Indianapolis, Indiana, United States
- University of Iowa Hospitals and Clinics - Iowa City, Iowa, United States
- Mission Cancer Blood - Waukee, Iowa, United States
- Cancer Center of Kansas - Wichita, Kansas, United States
- Mary Bird Perkins Cancer Center - Baton Rouge, Louisiana, United States
- MedStar Franklin Square Medical Center - Baltimore, Maryland, United States
- Frederick Health Hospital - James M Stockman Cancer Institute - Frederick, Maryland, United States
- University of Michigan Rogel Cancer Center - Ann Arbor, Michigan, United States
- Henry Ford Hospital - Detroit, Michigan, United States
- Cancer And Hematology Centers of Western Michigan PC - Grand Rapids, Michigan, United States
- Hattiesburg Clinic - Hattiesburg, Mississippi, United States
- Washington University School Of Medicine - St Louis, Missouri, United States
- Nebraska Cancer Specialists - Omaha, Nebraska, United States
- Astera Cancer Care - East Brunswick, New Jersey, United States
- Perlmutter Cancer Center at NYU Long Island - Mineola, New York, United States
- NYU Langone Medical Center NYU Hematology Associates - New York, New York, United States
- New York Cancer and Blood Specialists - Shirley, New York, United States
- Montefiore Einstein Comprehensive Cancer Center - The Bronx, New York, United States
- University of Buffalo Kaleida Health Cancer Care - Williamsville, New York, United States
- Gabrail Cancer Center - Canton, Ohio, United States
- University Hospital of Cleveland - Cleveland, Ohio, United States
- Oregon Health And Science University - Portland, Oregon, United States
- Alliance Cancer Specialists at Main Line - Penn Wynne, Pennsylvania, United States
- Thomas Jefferson University - Philadelphia, Pennsylvania, United States
- Fox Chase Cancer Center - Philadelphia, Pennsylvania, United States
- University Of Pittsburgh Medical Center UPMC Hillman Cancer Center - Pittsburgh, Pennsylvania, United States
- Tennessee Oncology Chattanooga - Chattanooga, Tennessee, United States
- SCRI Oncology Partners - Nashville, Tennessee, United States
- Tennessee Oncology - Nashville, Tennessee, United States
- Vanderbilt University Medical Center - Nashville, Tennessee, United States
- Texas Oncology West Texas - Abilene, Texas, United States
- Parkland Health and Hospital System - Dallas, Texas, United States
- Texas Oncology DFW - Dallas, Texas, United States
- UT Southwestern Medical Center - Dallas, Texas, United States
Showing 60 of 251 listed sites. See the official record for the complete list.
Read the full protocol, contacts and eligibility on ClinicalTrials.gov →