Image

Testing the Addition of Chemotherapy or Chemo-Immunotherapy to the Usual Surgery for Advanced Head and Neck Cancer

Exploring new treatments with surgery for advanced head and neck cancer.

Recruiting
18 years and older
All
Phase 2

This study aims to test adding chemotherapy (using drugs like carboplatin and paclitaxel) or chemo-immunotherapy (adding cemiplimab) to the usual surgery for patients with advanced head and neck cancer. This type of cancer, called squamous cell carcinoma, has returned or persisted after initial treatment. Carboplatin and cisplatin are medications that kill or slow cancer cell growth. Paclitaxel stops cancer cells from dividing. Cemiplimab is an immunotherapy drug that helps the body's immune system fight cancer. Salvage surgery is performed to remove tumor tissue after other treatments have failed. Radiation therapy uses high-energy rays to kill cancer cells.

  • This study involves several visits, including surgery and follow-up every few months for 4 years.
  • There are potential risks, such as side effects from drugs and surgery.
  • Patients may need to undergo blood tests, CT and PET scans during the study.

Eligibility: Patients must be 18 or older, with confirmed locally recurrent or persistent cancer, and have no distant metastasis. Prior radiation therapy is allowed if completed over 6 months before joining the study.

Study details
    Clinical Stage II HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8
    Clinical Stage III HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8
    Locally Recurrent Head and Neck Squamous Cell Carcinoma
    Locally Recurrent Hypopharyngeal Squamous Cell Carcinoma
    Locally Recurrent Laryngeal Squamous Cell Carcinoma
    Locally Recurrent Oral Cavity Squamous Cell Carcinoma
    Locally Recurrent Oropharyngeal Squamous Cell Carcinoma
    Stage II Laryngeal Cancer AJCC v8
    Stage II Lip and Oral Cavity Cancer AJCC v8
    Stage II Oropharyngeal (p16-Negative) Carcinoma AJCC v8
    Stage III Laryngeal Cancer AJCC v8
    Stage III Lip and Oral Cavity Cancer AJCC v8
    Stage III Oropharyngeal (p16-Negative) Carcinoma AJCC v8
    Stage IVA Laryngeal Cancer AJCC v8
    Stage IVA Lip and Oral Cavity Cancer AJCC v8
    Stage IVA Oropharyngeal (p16-Negative) Carcinoma AJCC v8
    Stage IVB Laryngeal Cancer AJCC v8
    Stage IVB Oropharyngeal (p16-Negative) Carcinoma AJCC v8

NCT07195734

National Cancer Institute (NCI)

25 April 2026

Step 1 Get in touch with the nearest study center
We have submitted the contact information you provided to the research team at {{SITE_NAME}}. A copy of the message has been sent to your email for your records.
Would you like to be notified about other trials? Sign up for Patient Notification Services.
Sign up

Send a message

Enter your contact details to connect with study team

Investigator Avatar

Primary Contact

  Other languages supported:

First name*
Last name*
Email*
Phone number*
Race
Ethnicity
Other language

FAQs

Learn more about clinical trials

What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

How long does a clinical trial take place?

The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

Do I get compensated for taking part in clinical trials?

Compensation varies per trial. Some offer payment or reimbursement for time and travel, while others may not.

How safe are clinical trials?

Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
Add a private note
  • abc Select a piece of text.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.