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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
Trial Status: active
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.
Inclusion 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 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
Exclusion Criteria
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
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT07276399.
Locations matching your search criteria
United States
Connecticut
New Haven
Yale University
Status: Active
Name Not Available
Trumbull
Smilow Cancer Hospital Care Center-Trumbull
Status: Active
Name Not Available
Waterford
Smilow Cancer Hospital Care Center - Waterford
Status: Active
Name Not Available
Georgia
Atlanta
Emory University Hospital/Winship Cancer Institute
Status: Active
Name Not Available
Michigan
Detroit
Wayne State University/Karmanos Cancer Institute
Status: Approved
Name Not Available
New York
Bronx
Montefiore Medical Center-Weiler Hospital
Status: Active
Name Not Available
New York
Laura and Isaac Perlmutter Cancer Center at NYU Langone