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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

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 5351247, California 5332921 92835

Valkyrie Clinical Trials
Los Angeles 5368361, California 5332921 90067

Yale Cancer Center
New Haven 4839366, Connecticut 4831725 06510

Emory University
Atlanta 4180439, Georgia 4197000 30308

Central Georgia Cancer Care
Macon 4207400, Georgia 4197000 31210

Cancer Care Specialists of Central Illinois
O'Fallon 4245926, Illinois 4896861 62269

University of Kentucky Medical Center
Lexington 4297983, Kentucky 6254925 40536

Karmanos Cancer Institute
Detroit 4990729, Michigan 5001836 48201 2013

NHO Revive Research Institute, LLC
Lincoln 5072006, Nebraska 5073708 68506

Laura & Isaac Perlmutter Cancer Center at NYU Langone Hospital - Long Island
Mineola 5127134, New York 5128638 11501

Laura and Isaac Perlmutter Cancer Center at NYU Langone Health
New York 5128581, New York 5128638 10016

Montefiore Medical Center
The Bronx 5110266, New York 5128638 10461

Bronx Veterans Affairs Medical Center
The Bronx 5110266, New York 5128638 10468

Carolina Cancer Research Center
Wilson 4499389, North Carolina 4482348 27893

Oregon Health And Science University
Portland 5746545, Oregon 5744337 97239

Texas Oncology-Central South
Waco 4739526, Texas 4736286 76712

Huntsman Cancer Institute
Salt Lake City 5780993, Utah 5549030 84112

Virginia Cancer Specialists
Arlington 4744709, Virginia 6254928 22201

More Details

Status
Recruiting
Sponsor
Janssen Research & Development, LLC

Study Contact

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

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.