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

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 cisplatin) in participants with refractory/metastatic (R/M) head and neck squamous cell carcinoma (HNSCC). HNSCC is a type of cancer that develops in the head and neck regions, including the outer tissue layer of the mouth and throat. This study will focus on participants with HNSCC who are treatment-naive (have not received prior treatment) in the R/M setting.

Trial Details

NCT ID
NCT07276399
Phase
PHASE3
Sponsor
Janssen Research & Development, LLC
Status
RECRUITING
Cancer Type
Head and Neck Cancer
Interventions
  • Amivantamab
  • Pembrolizumab
  • Carboplatin
  • 5-Flurouracil
  • Cisplatin
Locations (sample)
  • Chandler, Arizona, United States|33.30616,-111.84125
  • Tucson, Arizona, United States|32.22174,-110.92648
  • Fullerton, California, United States|33.87029,-117.92534
  • La Jolla, California, United States|32.84727,-117.2742
  • Los Angeles, California, United States|34.05223,-118.24368

Key Eligibility 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 g…
  • Have histologically or cytologically confirmed recurrent/metastatic (R/M) HNSCC that is considered incurable by local therapies: a. eligible primar…
  • Be treatment-naive for systemic therapy in the R/M setting
  • Have an ECOG performance status of 0 or 1

For full eligibility, visit ClinicalTrials.gov.

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