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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

Phase
Phase 3
Sponsor
Janssen Research & Development, LLC
Enrollment
500
Timeline
Dec 2025 → Jun 2029
About This Study

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 Criteria

Inclusion Criteria

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

Exclusion Criteria

  • 1Have an uncontrolled illness
  • 2Have untreated brain metastases or history of known presence of leptomeningeal disease
  • 3Have a history of clinically significant cardiovascular disease
  • 4Inadequate organ or bone marrow function
  • 5Known allergies, hypersensitivity, contraindications, or intolerance to excipients of: Amivantamab, Pembrolizumab, Carboplatin, Cisplatin, 5-FU and Hyaluronidase

Locations

22 sites participating in this study

Emory University

Atlanta, Georgia 30308

Recruiting

Providence St Jude Medical Center

Fullerton, California 92835

Recruiting

Valkyrie Clinical Trials

Los Angeles, California 90067

Recruiting
Data sourced from ClinicalTrials.govView on ClinicalTrials.gov →