A Study of Amivantamab in Addition to Standard of Care Agents (SOC) Compared With SOC Alone in Participants With Recurrent/Metastatic Head and Neck Cancer

Purpose

The purpose of this study is to compare anti-tumor activity of amivantamab in addition to pembrolizumab and carboplatin versus pembrolizumab, 5-fluorouracil (FU), and platinum therapy (carboplatin or cisplatin) in participants with refractory/metastatic (R/M) head and neck squamous cell carcinoma (HNSCC). HNSCC is a type of cancer that develops in the head and neck regions, including the outer tissue layer of the mouth and throat. This study will focus on participants with HNSCC who are treatment-naive (have not received prior treatment) in the R/M setting.

Condition

  • Squamous Cell Carcinoma of Head and Neck

Eligibility

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

Inclusion Criteria

  • Be more than or equal to (>=) 18 years of age (or the legal age of majority in the jurisdiction in which the study is taking place, whichever is greater) - Have histologically or cytologically confirmed recurrent/metastatic (R/M) HNSCC that is considered incurable by local therapies: a. eligible primary tumor locations are the oral cavity, oropharynx, hypopharynx, or larynx; b. Must not have a primary tumor site of nasopharynx or primary tumor of unknown location; c. Must have documented local testing results per local regulations; d. Human papillomavirus (HPV) status must be known for participants with primary tumor location in oropharynx via p16 test, HPV DNA test, or high-risk HPV in situ hybridization (ISH). Any known p16, HPV DNA, or high-risk HPV ISH status of tumor must be negative - Be treatment-naive for systemic therapy in the R/M setting - Have an ECOG performance status of 0 or 1 - Have measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) version (v).1.1

Exclusion Criteria

  • Have an uncontrolled illness - Have untreated brain metastases or history of known presence of leptomeningeal disease - Have a history of clinically significant cardiovascular disease - Inadequate organ or bone marrow function - Known allergies, hypersensitivity, contraindications, or intolerance to excipients of: Amivantamab, Pembrolizumab, Carboplatin, Cisplatin, 5-FU and Hyaluronidase

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: Pembrolizumab, Amivantamab, Carboplatin 		Participants will receive pembrolizumab, amivantamab and carboplatin.
  • Biological: Amivantamab
    Amivantamab will be administered.
    Other names:
    • JNJ-61186372
    • RYBREVANT
  • Biological: Pembrolizumab
    Pembrolizumab will be administered.
  • Drug: Carboplatin
    Carboplatin will be administered.
Active Comparator
Arm B: Pembrolizumab, 5-Flurouracil (5-FU), Carboplatin or Cisplatin 		Participants will receive pembrolizumab, 5-FU and carboplatin or cisplatin (platinum therapy).
  • Biological: Pembrolizumab
    Pembrolizumab will be administered.
  • Drug: Carboplatin
    Carboplatin will be administered.
  • Drug: 5-Flurouracil
    5-Flurouracil will be administered for over 4-day infusion period.
  • Drug: Cisplatin
    Cisplatin will be administered.

Recruiting Locations

Providence St Jude Medical Center
Fullerton, California 92835

Valkyrie Clinical Trials
Los Angeles, California 90067

Valkyrie Clinical Trials Murrieta
Murrieta, California 92562

Hartford Hospital
Hartford, Connecticut 06102

Yale Cancer Center
New Haven, Connecticut 06510

Emory University
Atlanta, Georgia 30308

Central Georgia Cancer Care
Macon, Georgia 31210

Rush University Medical Center Rush University Cancer Center Chicago
Chicago, Illinois 60607

The University of Chicago Medical Center (UCMC)
Chicago, Illinois 60637

Cancer Care Specialists of Central Illinois
O'Fallon, Illinois 62269

University of Kentucky Medical Center
Lexington, Kentucky 40536

Karmanos Cancer Institute
Detroit, Michigan 48201 2013

Washington University School Of Medicine
St Louis, Missouri 63108

NHO Revive Research Institute, LLC
Lincoln, Nebraska 68506

Laura & Isaac Perlmutter Cancer Center at NYU Langone Hospital - Long Island
Mineola, New York 11501

Laura and Isaac Perlmutter Cancer Center at NYU Langone Health
New York, New York 10016

Montefiore Medical Center
The Bronx, New York 10461

Bronx Veterans Affairs Medical Center
The Bronx, New York 10468

Carolina Cancer Research Center
Wilson, North Carolina 27893

Oregon Health And Science University
Portland, Oregon 97239

Tennessee Cancer Specialists
Knoxville, Tennessee 37909

Texas Oncology - San Antonio
Fredericksburg, Texas 78624

Texas Oncology-Central South
Waco, Texas 76712

Huntsman Cancer Institute
Salt Lake City, Utah 84112

Virginia Cancer Specialists
Arlington, Virginia 22201

More Details

Status
Recruiting
Sponsor
Janssen Research & Development, LLC

Study Contact

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