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Compares treatment options for Squamous Cell Carcinoma of Head and Neck
Official title 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
ClinicalTrials.gov ID: NCT07276399
What this study is testing
What is Amivantamab?
Amivantamab is an investigational medicine, being studied as a potential treatment for squamous cell carcinoma of head and neck.
Also referred to as JNJ-61186372, RYBREVANT.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
- Have histologically or cytologically confirmed recurrent/metastatic (R/M) HNSCC that is considered incurable by local therapies: a. eligible primary...
- 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 likely 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...
The study team makes the final eligibility decision.
Where it's taking place
- Chandler, Arizona, United States
- Tucson, Arizona, United States
- Fullerton, California, United States
- La Jolla, California, United States
- Los Angeles, California, United States
- Murrieta, California, United States
- Sacramento, California, United States
- Stanford, California, United States
- Hartford, Connecticut, United States
- New Haven, Connecticut, United States
- Fort Myers, Florida, United States
- Miami, Florida, United States
- Orlando, Florida, United States
- St. Petersburg, Florida, United States
- West Palm Beach, Florida, United States
- Atlanta, Georgia, United States
- Macon, Georgia, United States
- Chicago, Illinois, United States
- O'Fallon, Illinois, United States
- Lexington, Kentucky, United States
+ 150 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Chandler, Arizona, United States; Tucson, Arizona, United States; Fullerton, California, United States; La Jolla, California, United States; Los Angeles, California, United States; Murrieta, California, United States and 164 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.