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

Purpose

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.

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 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)

Study Design

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

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Arm A: Amivantamab + FOLFIRI 		Participants will receive amivantamab along with FOLFIRI (consisting of 5-fluorouracil, leucovorin calcium [folinic acid] or levoleucovorin, and irinotecan) as a chemotherapy regimen 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.
    Other names:
    • Folinic acid
  • Drug: Irinotecan
    Irinotecan will be administered as chemotherapy regimen.
Active Comparator
Arm B: Cetuximab or Bevacizumab + FOLFIRI 		Participants will receive either cetuximab or bevacizumab along with FOLFIRI as a chemotherapy regimen 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
  • Biological: Bevacizumab
    Bevacizumab will be administered.
    Other names:
    • Avastin
  • Drug: 5-fluorouracil
    5-fluorouracil will be administered as chemotherapy regimen.
  • Drug: Leucovorin calcium/Levoleucovorin
    Leucovorin calcium/Levoleucovorin will be administered as chemotherapy regimen.
    Other names:
    • Folinic acid
  • Drug: Irinotecan
    Irinotecan will be administered as chemotherapy regimen.

Recruiting Locations

Ironwood Cancer and Research Center
Chandler, Arizona 85224

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

University of Colorado Denver Anschultz Medical Campus
Aurora, Colorado 80045

Rocky Mountain Cancer Centers
Denver, Colorado 80218

Eastern Connecticut Hematology & Oncology Assoc.
Norwich, Connecticut 06360

Florida Cancer Specialists South
Fort Myers, Florida 33901

AdventHealth Cancer Institute
Orlando, Florida 32804

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

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

University Cancer And Blood Center LLC
Athens, Georgia 30607

Grady Memorial Hospital
Atlanta, Georgia 30303

Piedmont Cancer Institute
Atlanta, Georgia 30318

Winship Cancer Institute Emory University
Atlanta, Georgia 30322

Illinois Cancer Specialists
Arlington Heights, Illinois 60005

Illinois CancerCare
Peoria, Illinois 61615

Franciscan Health
Indianapolis, Indiana 46237

University of Iowa Hospitals and Clinics
Iowa City, Iowa 52242

Mission Cancer Blood
Waukee, Iowa 50263

Cancer Center of Kansas
Wichita, Kansas 67214

Mary Bird Perkins Cancer Center
Baton Rouge, Louisiana 70809

MedStar Franklin Square Medical Center
Baltimore, Maryland 21237

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

University of Michigan Rogel Cancer Center
Ann Arbor, Michigan 48109

Henry Ford Hospital
Detroit, Michigan 48202

Cancer And Hematology Centers of Western Michigan PC
Grand Rapids, Michigan 49503

Hattiesburg Clinic
Hattiesburg, Mississippi 39401

Washington University School Of Medicine
St Louis, Missouri 63110

Nebraska Cancer Specialists
Omaha, Nebraska 68130

Astera Cancer Care
East Brunswick, New Jersey 08816

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

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

New York Cancer and Blood Specialists
Shirley, New York 11967

Montefiore Einstein Comprehensive Cancer Center
The Bronx, New York 10461

Gabrail Cancer Center
Canton, Ohio 44718

University Hospital of Cleveland
Cleveland, Ohio 44106

Oregon Health And Science University
Portland, Oregon 97239

Alliance Cancer Specialists at Main Line
Penn Wynne, Pennsylvania 19096

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

Tennessee Oncology Chattanooga
Chattanooga, Tennessee 37404

SCRI Oncology Partners
Nashville, Tennessee 37203

Tennessee Oncology
Nashville, Tennessee 37203

Vanderbilt University Medical Center
Nashville, Tennessee 37232

Texas Oncology West Texas
Abilene, Texas 79606

Parkland Health and Hospital System
Dallas, Texas 75235

Texas Oncology DFW
Dallas, Texas 75246

UT Southwestern Medical Center
Dallas, Texas 75390

MD Anderson Cancer Center
Houston, Texas 77030

Baylor Scott & White Medical Center
Round Rock, Texas 77845

Texas Oncology - San Antonio
San Antonio, Texas 78240

Scott And White Memorial Hospital
Temple, Texas 76508

UT Health East Texas HOPE Cancer Center
Tyler, Texas 75701

Virginia Cancer Specialists
Arlington, Virginia 22201

Richmond VA Medical Center
Richmond, Virginia 23249

VCU Massey Comprehensive Cancer Center
Richmond, Virginia 23298

Providence Regional Cancer System
Lacey, Washington 98503

Fred Hutchinson Cancer Research Center
Seattle, Washington 98109

Medical College Of Wisconsin
Milwaukee, Wisconsin 53226

Pan American Center for Oncology Trials LLC
San Juan, 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