Study on Adding Amivantamab to Standard Treatment for Recurrent or Metastatic Head and Neck Cancer

Sponsor: Janssen Research & Development, LLC

Sponsor score: 60

ClinicalTrials ID:NCT07276399

This clinical trial is testing whether adding the drug amivantamab to standard treatments can improve outcomes for patients with recurrent or metastatic head and neck cancer. The study compares the effectiveness of amivantamab combined with pembrolizumab and carboplatin against the standard treatment of pembrolizumab, 5-fluorouracil, and platinum therapy.

Patient Parameters

Program Overview

The aim of this study is to see if adding amivantamab to the usual treatment can better fight cancer in patients with recurrent or metastatic head and neck squamous cell carcinoma (HNSCC). HNSCC is a type of cancer that occurs in areas like the mouth and throat. This study focuses on patients who have not yet received treatment for their recurrent or metastatic cancer.

Eligibility Criteria

Inclusion Criteria

  • Must be 18 years or older.
  • Have a confirmed diagnosis of recurrent or metastatic head and neck squamous cell carcinoma (HNSCC) that cannot be cured with local treatments.
    • Eligible cancer locations include the mouth, throat, and voice box.
    • Cancer must not originate from the nasopharynx or an unknown location.
    • HPV status must be known for throat cancers and must be negative.
  • Must not have received systemic therapy for recurrent or metastatic cancer.
  • Must be in good general health with an ECOG performance status of 0 or 1.
  • Must have measurable cancer according to specific medical criteria.

Exclusion Criteria

  • Have an uncontrolled illness.
  • Have untreated cancer that has spread to the brain or a history of cancer in the brain's lining.
  • Have a history of serious heart disease.
  • Have poor organ or bone marrow function.
  • Have known allergies or intolerances to any of the study drugs, including Amivantamab, Pembrolizumab, Carboplatin, Cisplatin, 5-FU, and Hyaluronidase.

Locations

FACILITYZIPCITYSTATE
Ironwood Cancer and Research Center85224ChandlerArizona
Providence St Jude Medical Center92835FullertonCalifornia
Valkyrie Clinical Trials90067Los AngelesCalifornia
Valkyrie Clinical Trials Murrieta92562MurrietaCalifornia
Stanford University Medical Center94304StanfordCalifornia
Hartford Hospital06102HartfordConnecticut
Yale Cancer Center06510New HavenConnecticut
Florida Cancer Specialists South33901Fort MyersFlorida
University of Miami Sylvester Comprehensive Cancer Center33136MiamiFlorida
Florida Cancer Specialists North Region33701-4553St. PetersburgFlorida

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