ClinicaliQ Trial Snapshot
- 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 — Recruiting • Phase III • Oncology • NCT07276399.
- What is being tested: Amivantamab (a bispecific antibody targeting EGFR and MET) combined with pembrolizumab and carboplatin, compared to standard chemotherapy-immunotherapy combinations (pembrolizumab with 5-FU and platinum agents) in recurrent/metastatic head and neck cancer.
- Patient eligibility overview: Adults with refractory or metastatic head and neck squamous cell carcinoma (HNSCC) who have progressed despite prior treatment; specific performance status and organ function criteria apply.
Use This Page For
- Quick orientation before opening the registry record.
- Checking recruitment status, phase and sponsor at a glance.
- Connecting this trial to nearby guidelines, Drug Science and education.
What This Trial Is Studying
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 Snapshot
- : * 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
Use the source registry for the full inclusion and exclusion criteria before discussing referral or enrolment.