Trial comparing treatments 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?
This is an investigational medicine being studied as a potential treatment for head and neck cancer. It is designed to bind to specific proteins on cancer cells to help the body's immune system recognize and attack them.
Also referred to as 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
- This study is testing whether adding amivantamab to standard drugs works better than standard drugs alone. It looks at how well these options fight the cancer.
- Who it's for
- You may be able to join if you have head and neck cancer that has spread. You must not have had treatment for this cancer before.
- What's involved
- You would get amivantamab plus standard drugs, or just the standard drugs. You would also get regular check-ups and tests.
- Time commitment
- The study lasts for a set time with regular visits to the clinic.
- 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.
- 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 is enrolling
- 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
- San Francisco, 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
+ 157 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, but 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?
This study is enrolling now at 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 171 more locations. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.