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Clinical Trials in India / NCT06750094
Recruiting Phase 3

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

NCT06750094 · tracked via the Priya Life Science India tracker
Sponsor
Janssen Research & Development, LLC
Phase
Phase 3
Started
2024-12-12
Last updated
2026-08-28

Condition(s) studied

Colorectal Neoplasms

Investigational drug(s) / intervention(s)

AmivantamabCetuximabBevacizumab5-fluorouracilLeucovorin calcium/LevoleucovorinIrinotecan

Amivantamab: Amivantamab will be administered.

Cetuximab: Cetuximab will be administered.

Bevacizumab: Bevacizumab will be administered.

5-fluorouracil: 5-fluorouracil will be administered as chemotherapy regimen.

Leucovorin calcium/Levoleucovorin: Leucovorin calcium/Levoleucovorin will be administered as chemotherapy regimen.

Irinotecan: Irinotecan will be administered as chemotherapy regimen.

Study 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

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
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)

Primary outcome measure(s)

Trial sites (251)

FacilityCityRegionStatus
Ironwood Cancer and Research Center Chandler Arizona Recruiting
Banner MD Anderson Cancer Center Gilbert Arizona Recruiting
Arizona Oncology Associates PC NAHOA Prescott Arizona Completed
St. Bernard's Medical Center Jonesboro Arkansas Recruiting
Highlands Oncology Group Springdale Arkansas Recruiting
CBCC Global Research Bakersfield California Recruiting
Los Angeles Cancer Network Glendale California Recruiting
Cancer and Blood Specialty Clinic Los Alamitos California Recruiting
USC Norris Comprehensive Cancer Center Los Angeles California Recruiting
UCLA Santa Monica California Recruiting
Providence Medical Foundation Santa Rosa California Recruiting
Torrance Memorial Physicians Network Torrance California Recruiting
University of Colorado Denver Anschultz Medical Campus Aurora Colorado Recruiting
Rocky Mountain Cancer Centers Denver Colorado Recruiting
Eastern Connecticut Hematology & Oncology Assoc. Norwich Connecticut Completed
Florida Cancer Specialists South Fort Myers Florida Recruiting
Mount Sinai Medical Center Campus Miami Beach Florida Completed
AdventHealth Cancer Institute Orlando Florida Recruiting
Florida Cancer Specialists North Region St. Petersburg Florida Recruiting
Florida Cancer Specialists East West Palm Beach Florida Recruiting
University Cancer And Blood Center LLC Athens Georgia Recruiting
Grady Memorial Hospital Atlanta Georgia Recruiting
Piedmont Cancer Institute Atlanta Georgia Recruiting
Winship Cancer Institute Emory University Atlanta Georgia Recruiting
Illinois Cancer Specialists Arlington Heights Illinois Recruiting
Illinois CancerCare Peoria Illinois Recruiting
Franciscan Health Indianapolis Indiana Recruiting
University of Iowa Hospitals and Clinics Iowa City Iowa Recruiting
Mission Cancer Blood Waukee Iowa Recruiting
Cancer Center of Kansas Wichita Kansas Recruiting
Mary Bird Perkins Cancer Center Baton Rouge Louisiana Recruiting
MedStar Franklin Square Medical Center Baltimore Maryland Recruiting
Frederick Health Hospital - James M Stockman Cancer Institute Frederick Maryland Recruiting
University of Michigan Rogel Cancer Center Ann Arbor Michigan Recruiting
Henry Ford Hospital Detroit Michigan Recruiting
Cancer And Hematology Centers of Western Michigan PC Grand Rapids Michigan Recruiting
Hattiesburg Clinic Hattiesburg Mississippi Recruiting
Washington University School Of Medicine St Louis Missouri Recruiting
Nebraska Cancer Specialists Omaha Nebraska Recruiting
Astera Cancer Care East Brunswick New Jersey Recruiting

+ 211 more sites — see the full list on the official registry below.

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06750094 on ClinicalTrials.gov ↗ ← All trials in India