Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at Los Angeles, California and other locations
Dates
study started
study ends around

Description

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.

Official Title

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

Keywords

Squamous Cell Carcinoma of Head and Neck, amivantamab, pembrolizumab, Carboplatin, Cisplatin, 5-Flurouracil, Pembrolizumab, Amivantamab, Carboplatin

Eligibility

You can join if…

Open to people ages 18 years and up

  • 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

You CAN'T join if...

  • 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

Locations

  • Valkyrie Clinical Trials accepting new patients
    Los Angeles California 90067 United States
  • Providence St Jude Medical Center accepting new patients
    Fullerton California 92835 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Janssen Research & Development, LLC
Links
Sign up for this study
ID
NCT07276399
Phase
Phase 3 research study
Study Type
Interventional
Participants
Expecting 500 study participants
Last Updated