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

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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

Status
Active
Cancer Type
Head and Neck Cancer
Unknown Primary
Trial Phase
Phase III
Eligibility
18 Years and older, Male and Female
Study Type
Treatment
NCT ID
NCT07276399
Protocol IDs
61186372HNC3001 (primary)
NCI-2025-09312
2025
2025-521917-24-00
61186372HNC3001
Study Sponsor
Janssen Research & Development, LLC

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 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.

Eligibility

  1. 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)
  2. 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
  3. Be treatment-naive for systemic therapy in the R/M setting
  4. Have an ECOG performance status of 0 or 1
  5. Have measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) version (v).1.1

Treatment Sites in Georgia

Emory University Hospital - Midtown


550 Peachtree Street NE
Atlanta, GA 30308
404-686-4411
www.emoryhealthcare.org

Winship Cancer Institute of Emory University


1365 Clifton Road NE
Building C
Atlanta, GA 30322
winshipcancer.emory.edu

**Clinical trials are research studies that involve people. These studies test new ways to prevent, detect, diagnose, or treat diseases. People who take part in cancer clinical trials have an opportunity to contribute to scientists’ knowledge about cancer and to help in the development of improved cancer treatments. They also receive state-of-the-art care from cancer experts... Click here to learn more about clinical trials.