A Phase 3, Randomized, Open-Label, Multicenter Study of Amivantamab in Addition to Carboplatin and Pembrolizumab, Compared to Standard of Care Platinum and Pembrolizumab and 5-FU, in Participants with Treatment-Naïve Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma.
Primary:
To compare anti-tumor activity.
Secondary:
- To further assess measures of clinical benefit
- To assess safety and tolerability
- To assess disease symptoms, HRQoL, and treatment tolerability
- For amivantamab-treated participants only: To explore the relationship between PK or immunogenicity and selected endpoints in amivantamab-treated participants (including but not limited to efficacy and safety).
CARBOPLATIN
Pembrolizumab (MK-3475)
- RWJBarnabas Health
- Community Medical Center
- Cooperman Barnabas, Livingston
- Monmouth Medical Center
- Rutgers University
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
Please note that we have obtained the inclusion and exclusion criteria information from the National Institutes of Health’s clinical trials web site ClinicalTrials.gov. The listed criteria may not necessarily reflect recent amendments to the protocol and the current criteria.
For further information about clinical trials, please contact us at 732-235-7356.