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RECRUITINGPhase 3INTERVENTIONAL

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

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

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: - 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 diagnosed by tissue sample (biopsy-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 You should be able to carry out daily activities with 0 level of ability (ECOG 0) or 1 - Have measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) version (v).1.1 Who Should NOT Join This Trial: - 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 Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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

Treatments Being Tested

BIOLOGICAL

Amivantamab

Amivantamab will be administered.

BIOLOGICAL

Pembrolizumab

Pembrolizumab will be administered.

DRUG

Carboplatin

Carboplatin will be administered.

DRUG

5-Flurouracil

5-Flurouracil will be administered for over 4-day infusion period.

DRUG

Cisplatin

Cisplatin will be administered.

Locations (20)

Providence St Jude Medical Center
Fullerton, California, United States
Valkyrie Clinical Trials
Los Angeles, California, United States
Valkyrie Clinical Trials Murrieta
Murrieta, California, United States
Hartford Hospital
Hartford, Connecticut, United States
Yale Cancer Center
New Haven, Connecticut, United States
Emory University
Atlanta, Georgia, United States
Central Georgia Cancer Care
Macon, Georgia, United States
Rush University Medical Center Rush University Cancer Center Chicago
Chicago, Illinois, United States
The University of Chicago Medical Center (UCMC)
Chicago, Illinois, United States
Cancer Care Specialists of Central Illinois
O'Fallon, Illinois, United States
University of Kentucky Medical Center
Lexington, Kentucky, United States
Karmanos Cancer Institute
Detroit, Michigan, United States
Washington University School Of Medicine
St Louis, Missouri, United States
NHO Revive Research Institute, LLC
Lincoln, Nebraska, United States
Laura & Isaac Perlmutter Cancer Center at NYU Langone Hospital - Long Island
Mineola, New York, United States
Laura and Isaac Perlmutter Cancer Center at NYU Langone Health
New York, New York, United States
Montefiore Medical Center
The Bronx, New York, United States
Bronx Veterans Affairs Medical Center
The Bronx, New York, United States
Carolina Cancer Research Center
Wilson, North Carolina, United States
Oregon Health And Science University
Portland, Oregon, United States