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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).

Protocol Number: 032508
Phase: Phase III
Applicable Disease Sites: Lung
Drugs Involved: Amivantamab
CARBOPLATIN
Pembrolizumab (MK-3475)
Principal Investigator: Missak Haigentz
Scope: National
Therapies Involved: Chemotherapy multiple agents systemic
Participating Institutions:
  • RWJBarnabas Health
    • Community Medical Center
    • Cooperman Barnabas, Livingston
    • Monmouth Medical Center
  • Rutgers University
Inclusion & Exclusion Criteria

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.