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 5289282, Arizona 5551752 85224

Banner MD Anderson Cancer Center
Gilbert 5295903, Arizona 5551752 85234

Arizona Oncology Associates PC NAHOA
Prescott 5309842, Arizona 5551752 86301

St. Bernard's Medical Center
Jonesboro 4116834, Arkansas 4099753 72401

CBCC Global Research
Bakersfield 5325738, California 5332921 93309

Los Angeles Cancer Network
Glendale 5352423, California 5332921 91204

Cancer and Blood Specialty Clinic
Los Alamitos 5368304, California 5332921 90720

USC Norris Comprehensive Cancer Center
Los Angeles 5368361, California 5332921 90033

UCLA
Santa Monica 5393212, California 5332921 90404

Providence Medical Foundation
Santa Rosa 5393287, California 5332921 95403

Torrance Memorial Physicians Network
Torrance 5403022, California 5332921 90505

University of Colorado Denver Anschultz Medical Campus
Aurora 5412347, Colorado 5417618 80045

Rocky Mountain Cancer Centers
Denver 5419384, Colorado 5417618 80218

Eastern Connecticut Hematology & Oncology Assoc.
Norwich 4839843, Connecticut 4831725 06360

Florida Cancer Specialists South
Fort Myers 4155995, Florida 4155751 33901

Mount Sinai Medical Center Campus
Miami Beach 4164143, Florida 4155751 33140

AdventHealth Cancer Institute
Orlando 4167147, Florida 4155751 32804

Florida Cancer Specialists North Region
St. Petersburg 4171563, Florida 4155751 33705

Florida Cancer Specialists East
West Palm Beach 4177887, Florida 4155751 33401-3406

University Cancer And Blood Center LLC
Athens 4180386, Georgia 4197000 30607

Grady Memorial Hospital
Atlanta 4180439, Georgia 4197000 30303

Piedmont Cancer Institute
Atlanta 4180439, Georgia 4197000 30318

Winship Cancer Institute Emory University
Atlanta 4180439, Georgia 4197000 30322

Illinois CancerCare
Peoria 4905687, Illinois 4896861 61615

Mary Bird Perkins Cancer Center
Baton Rouge 4315588, Louisiana 4331987 70809

MedStar Franklin Square Medical Center
Baltimore 4347778, Maryland 4361885 21237

University of Michigan Rogel Cancer Center
Ann Arbor 4984247, Michigan 5001836 48109

Henry Ford Hospital
Detroit 4990729, Michigan 5001836 48202

Cancer And Hematology Centers of Western Michigan PC
Grand Rapids 4994358, Michigan 5001836 49503

Hattiesburg Clinic
Hattiesburg 4429295, Mississippi 4436296 39401

Washington University School Of Medicine
St Louis 4407066, Missouri 4398678 63110

Nebraska Cancer Specialists
Omaha 5074472, Nebraska 5073708 68130

Astera Cancer Care
East Brunswick 5097402, New Jersey 5101760 08816

Perlmutter Cancer Center at NYU Long Island
Mineola 5127134, New York 5128638 11501

NYU Langone Medical Center NYU Hematology Associates
New York 5128581, New York 5128638 10016

New York Cancer and Blood Specialists
Shirley 5138022, New York 5128638 11967

Montefiore Einstein Comprehensive Cancer Center
The Bronx 5110266, New York 5128638 10461

University Hospital of Cleveland
Cleveland 5150529, Ohio 5165418 44106

Oregon Health And Science University
Portland 5746545, Oregon 5744337 97239

Alliance Cancer Specialists at Main Line
Penn Wynne 4560291, Pennsylvania 6254927 19096

Thomas Jefferson University
Philadelphia 4560349, Pennsylvania 6254927 19107

Fox Chase Cancer Center
Philadelphia 4560349, Pennsylvania 6254927 19111

University Of Pittsburgh Medical Center UPMC Hillman Cancer Center
Pittsburgh 5206379, Pennsylvania 6254927 15232 1301

Tennessee Oncology
Chattanooga 4612862, Tennessee 4662168 37404

SCRI Oncology Partners
Nashville 4644585, Tennessee 4662168 37203

Tennessee Oncology
Nashville 4644585, Tennessee 4662168 37203

Vanderbilt University Medical Center
Nashville 4644585, Tennessee 4662168 37232

Texas Oncology West Texas
Abilene 4669635, Texas 4736286 79606

Texas Oncology DFW
Dallas 4684888, Texas 4736286 75246

UT Southwestern Medical Center
Dallas 4684888, Texas 4736286 75390

MD Anderson Cancer Center
Houston 4699066, Texas 4736286 77030

Texas Oncology - San Antonio
San Antonio 4726206, Texas 4736286 78240

Scott And White Memorial Hospital
Temple 4735966, Texas 4736286 76508

UT Health East Texas HOPE Cancer Center
Tyler 4738214, Texas 4736286 75701

Virginia Cancer Specialists
Arlington 4744709, Virginia 6254928 22201

VCU Massey Comprehensive Cancer Center
Richmond 4781708, Virginia 6254928 23298

Providence Regional Cancer System
Lacey 5800112, Washington 5815135 98503

Fred Hutchinson Cancer Research Center
Seattle 5809844, Washington 5815135 98109

Medical College Of Wisconsin
Milwaukee 5263045, Wisconsin 5279468 53226

Pan American Center for Oncology Trials LLC
San Juan 4568127, 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