Study on Adding Amivantamab to Standard Treatment for Recurrent or Metastatic Head and Neck Cancer
Sponsor: Janssen Research & Development, LLC
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
| Parameter | Options |
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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
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Ironwood Cancer and Research Center | 85224 | Chandler | Arizona |
| Providence St Jude Medical Center | 92835 | Fullerton | California |
| Valkyrie Clinical Trials | 90067 | Los Angeles | California |
| Valkyrie Clinical Trials Murrieta | 92562 | Murrieta | California |
| Stanford University Medical Center | 94304 | Stanford | California |
| Hartford Hospital | 06102 | Hartford | Connecticut |
| Yale Cancer Center | 06510 | New Haven | Connecticut |
| Florida Cancer Specialists South | 33901 | Fort Myers | Florida |
| University of Miami Sylvester Comprehensive Cancer Center | 33136 | Miami | Florida |
| Florida Cancer Specialists North Region | 33701-4553 | St. Petersburg | Florida |
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