Dysautonomia International

A Study of Amivantamab and mFOLFOX6 or FOLFIRI Versus Cetuximab and mFOLFOX6 or FOLFIRI as First-line Treatment in Participants With KRAS/NRAS and BRAF Wild-type Unresectable or Metastatic Left-sided Colorectal Cancer

Purpose

The purpose of this study is to compare how long the participants are disease-free (progression-free survival) when treated with amivantamab and chemotherapy with 5-fluorouracil, leucovorin calcium (folinic acid) or levoleucovorin, oxaliplatin (mFOLFOX6) or 5-fluorouracil, leucovorin calcium (folinic acid) or levoleucovorin, and irinotecan hydrochloride (FOLFIRI) versus cetuximab and mFOLFOX6 or FOLFIRI in adult participants with Kirsten rat sarcoma viral oncogene homolog (KRAS)/ Neuroblastoma RAS viral oncogene homolog (NRAS) and v-Raf murine sarcoma viral oncogene homolog B1 (BRAF) wild type (WT) unresectable or metastatic left-sided colorectal cancer.

Condition

Colorectal Neoplasms

Eligibility

Eligible Ages: Over 18 Years
Eligible Sex: All
Accepts Healthy Volunteers: No

Inclusion Criteria

Have histologically or cytologically confirmed adenocarcinoma of the left-sided colorectal cancer. Participants must have unresectable or metastatic disease - Determined to have Kirsten rat sarcoma viral oncogene (KRAS), neuroblastoma RAS viral oncogene homolog (NRAS), and v-raf murine sarcoma viral oncogene homolog B (BRAF) wild-type (WT) tumor by local and/or central testing (if available) - Must agree to the submission of fresh tumor tissue - Have measurable disease according to RECIST v1.1 - Has not received any prior systemic therapy for unresectable or metastatic colorectal cancer (CRC). Prior adjuvant/neoadjuvant therapy in the non-metastatic disease is permitted. However, the last course of adjuvant or neoadjuvant chemotherapy must have concluded greater than (>) 12 months prior to CRC recurrence/metastases - Have an eastern cooperative oncology group (ECOG) performance status (PS) of 0 or 1

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: (a) amivantamab or cetuximab, (b) any component of mFOLFOX6 and, (c) 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 and human epidermal growth factor receptor 2 (HER2)-positive/amplified tumor - Has prior exposure to any agents that target epidermal growth factor receptor (EGFR), mesenchymal epithelial transition (MET) or vascular endothelial growth factor (VEGF)

Study Design

Phase: Phase 3
Study Type: Interventional
Allocation: Randomized
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
Masking: None (Open Label)

Arm Groups

Arm	Description	Assigned Intervention
Experimental Arm A: Amivantamab in Combination With Chemotherapy	Participants will receive amivantamab in combination with chemotherapy (mFOLFOX6 [chemotherapy consisting of 5-fluorouracil, leucovorin calcium (folinic acid) or levoleucovorin, and oxaliplatin] or FOLFIRI [chemotherapy consisting of 5-fluorouracil, leucovorin calcium (folinic acid) or levoleucovorin, and irinotecan hydrochloride]) for 28-days treatment cycles and will continue to receive the treatment until radiographic disease progression or other discontinuation criteria are met.	Biological: Amivantamab Amivantamab will be administered. Other names: JNJ-61186372 Drug: 5-fluorouracil 5-fluorouracil will be administered as chemotherapy regimen. Drug: Leucovorin calcium/Levoleucovorin Leucovorin calcium/Levoleucovorin will be administered as chemotherapy regimen. Drug: Oxaliplatin Oxaliplatin will be administered as chemotherapy regimen. Drug: Irinotecan Hydrochloride Irinotecan hydrochloride will be administered as chemotherapy regimen.
Active Comparator Arm B: Cetuximab in Combination With Chemotherapy	Participants will receive cetuximab in combination with chemotherapy (mFOLFOX6 or FOLFIRI) for 28-days treatment cycles and will continue to receive the treatment until radiographic disease progression or other discontinuation criteria are met.	Biological: Cetuximab Cetuximab will be administered. Other names: Erbitux Drug: 5-fluorouracil 5-fluorouracil will be administered as chemotherapy regimen. Drug: Leucovorin calcium/Levoleucovorin Leucovorin calcium/Levoleucovorin will be administered as chemotherapy regimen. Drug: Oxaliplatin Oxaliplatin will be administered as chemotherapy regimen. Drug: Irinotecan Hydrochloride Irinotecan hydrochloride will be administered as chemotherapy regimen.

Recruiting Locations

Banner MD Anderson Cancer Center
Gilbert, Arizona 85234

St. Bernard's Medical Center
Jonesboro, Arkansas 72401

Highlands Oncology Group
Springdale, Arkansas 72762

CBCC Global Research
Bakersfield, California 93309

Los Angeles Cancer Network
Glendale, California 91204

Cancer and Blood Specialty Clinic
Los Alamitos, California 90720

USC Norris Comprehensive Cancer Center
Los Angeles, California 90033

UCLA
Santa Monica, California 90404

Providence Medical Foundation
Santa Rosa, California 95403

Torrance Memorial Physicians Network
Torrance, California 90505

Rocky Mountain Cancer Centers
Denver, Colorado 80218

Yale University School Of Medicine
New Haven, Connecticut 06519

Georgetown Univ Medical Center Lombardi Cancer Center
Washington D.C., District of Columbia 20007

Florida Cancer Specialists South
Fort Myers, Florida 33901

AdventHealth Medical Group Oncology and Hematology at Orlando
Orlando, Florida 32804

Florida Cancer Specialists North Region
St. Petersburg, Florida 33701-4553

Florida Cancer Specialists East
West Palm Beach, Florida 33401-3406

Grady Memorial Hospital
Atlanta, Georgia 30303

Winship Cancer Institute Emory University
Atlanta, Georgia 30322

Illinois Cancer Specialists
Arlington Heights, Illinois 60005

Illinois CancerCare
Peoria, Illinois 61615

Fort Wayne Medical Oncology & Hematology
Fort Wayne, Indiana 46804

University of Iowa Hospital
Iowa City, Iowa 52242

Mission Cancer Blood
Waukee, Iowa 50263

Cancer Center of Kansas
Wichita, Kansas 67214

Ochsner Clinic Foundation
New Orleans, Louisiana 70121

MedStar Franklin Square Medical Center
Baltimore, Maryland 21237

Frederick Health Hospital - James M Stockman Cancer Institute
Frederick, Maryland 21702-4337

VA Ann Arbor Healthcare System
Ann Arbor, Michigan 48105

University of Michigan
Ann Arbor, Michigan 48109

Henry Ford Hospital
Detroit, Michigan 48202

Start Midwest
Grand Rapids, Michigan 49503

Hattiesburg Clinic
Hattiesburg, Mississippi 39401

Washington University School Of Medicine
St Louis, Missouri 63110

Nebraska Cancer Specialists Midwest Cancer Center
Omaha, Nebraska 68130

Comprehensive Cancer Centers of Nevada
Las Vegas, Nevada 89169

Astera Cancer Care
East Brunswick, New Jersey 08816

Rutgers Cancer Institute
New Brunswick, New Jersey 08901

University of New Mexico Cancer Center
Albuquerque, New Mexico 87102

Perlmutter Cancer Center at NYU Long Island
Mineola, New York 11501

Mount Sinai
New York, New York 10003

Mount Sinai West
New York, New York 10009

NYU Langone Medical Center NYU Hematology Associates
New York, New York 10016

Herbert Irving Comprehensive Cancer Center Columbia University Medical Center
New York, New York 10032

New York Cancer and Blood Specialists
Shirley, New York 11967

Montefiore Einstein Comprehensive Cancer Center
The Bronx, New York 10461

University of North Carolina at Chapel Hill
Chapel Hill, North Carolina 27599

Gabrail Cancer Center
Canton, Ohio 44718

University Hospitals Cleveland Medical Center
Cleveland, Ohio 44106

Cleveland Clinic Cancer Center Fairview Hospital Moll Pavilion
Cleveland, Ohio 44111

Taussig Cancer Insititute Cleveland Clinic
Cleveland, Ohio 44195

Cleveland Clinic Cancer Center Independence Family Health Center
Independence, Ohio 44131

Cleveland Clinic Cancer Center Mansfield
Mansfield, Ohio 44906

Cleveland Clinic Cancer Center Hillcrest Hospital
Mayfield Heights, Ohio 44124

Cleveland Clinic Cancer Centers Sandusky
Sandusky, Ohio 44870

Cleveland Clinic Cancer Center Strongsville
Strongsville, Ohio 44136

Cleveland Clinic Cancer Center South Pointe Hospital
Warrensville Heights, Ohio 44122

Wooster Milltown Specialty and Surgery Center
Wooster, Ohio 44691

Oregon Health And Science University
Portland, Oregon 97239

Thomas Jefferson University
Philadelphia, Pennsylvania 19107

Fox Chase Cancer Center
Philadelphia, Pennsylvania 19111

University Of Pittsburgh Medical Center UPMC Hillman Cancer Center
Pittsburgh, Pennsylvania 15232 1301

SCRI Oncology Partners
Nashville, Tennessee 37203

Texas Oncology West Texas
Abilene, Texas 79606

Texas Oncology DFW
Dallas, Texas 75246

UT Southwestern
Dallas, Texas 75390

MD Anderson Cancer Center
Houston, Texas 77030

Baylor Scott and White Health 1
Round Rock, Texas 78665

Texas Oncology - San Antonio
San Antonio, Texas 78240

Baylor Scott and White Health
Temple, Texas 76508

Virginia Cancer Specialists
Arlington, Virginia 22201

Inova Schar Cancer Institute Dept of Fairfax Hospital
Fairfax, Virginia 22031

Richmond VA Medical Center
Richmond, Virginia 23249

VCU Massey Comprehensive Cancer Center
Richmond, Virginia 23298

Swedish Cancer Institute Edmonds
Edmonds, Washington 98026

Swedish Cancer Institute Issaquah
Issaquah, Washington 98029

Swedish Cancer Institute
Seattle, Washington 98104

Fred Hutchinson Cancer Research Center
Seattle, Washington 98109

William S. Middleton Memorial VA
Madison, Wisconsin 53705

Pan American Center for Oncology Trials LLC
Barrio Monacillos, Puerto Rico 00935

More Details

Status: Recruiting
Sponsor: Janssen Research & Development, LLC

Study Contact

Study Contact
844-434-4210
Participate-In-This-Study1@its.jnj.com