Status:
RECRUITING
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
Lead Sponsor:
Janssen Research & Development, LLC
Conditions:
Squamous Cell Carcinoma of Head and Neck
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 3 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 18 2029
Estimated Enrollment :
500 Patients enrolled
Trial Details
Trial ID
NCT07276399
Start Date
December 3 2025
End Date
June 18 2029
Last Update
March 13 2026
Active Locations (137)
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1
Providence St Jude Medical Center
Fullerton, California, United States, 92835
2
Valkyrie Clinical Trials
Los Angeles, California, United States, 90067
3
Valkyrie Clinical Trials Murrieta
Murrieta, California, United States, 92562
4
Hartford Hospital
Hartford, Connecticut, United States, 06102