Study on Pembrolizumab and Chemotherapy Before and After Surgery for Treatable, Returning Head and Neck Cancer
Sponsor: Dana-Farber Cancer Institute
ClinicalTrials ID:NCT05726370
This clinical trial is testing the safety and effectiveness of using the immunotherapy drug pembrolizumab with chemotherapy before and after surgery in patients with squamous cell carcinoma of the head and neck (HNSCC) that can be surgically removed and has returned.
Patient Parameters
| Parameter | Options |
|---|
Program Overview
The study aims to find out if combining pembrolizumab, an immunotherapy drug, with chemotherapy drugs (docetaxel, cisplatin, or carboplatin) before surgery can help control head and neck cancer. After surgery, pembrolizumab will continue for about a year to see if it helps prevent the cancer from coming back. Pembrolizumab is not yet approved for use in this specific setting, but it is approved for advanced cases where surgery is not possible. The study will last up to 5 years and involve about 28 participants.
Description
This Phase II study is testing a treatment plan that includes pembrolizumab, a drug that helps the immune system fight cancer, combined with chemotherapy drugs (cisplatin or carboplatin, and docetaxel) before surgery. After surgery, patients will continue to receive pembrolizumab for about a year. The study involves several visits for treatment, scans, biopsies, and blood tests. While pembrolizumab is approved for advanced head and neck cancer, it is not yet approved for use before and after surgery. The study is expected to last up to 5 years and will include about 28 participants. Merck Sharp & Dohme LLC is supporting the study and providing the study drug.
Eligibility Criteria
Inclusion Criteria
- Have a confirmed diagnosis of recurrent squamous cell carcinoma of the head and neck that can be surgically removed.
- Be a candidate for surgery to remove the cancer.
- Have at least 6 months since completing previous treatment for head and neck cancer.
- Be willing to undergo a biopsy before treatment and provide tissue samples.
- Any smoking history is allowed.
- Any HPV status of the tumor is allowed, but oropharyngeal cancer patients must undergo HPV testing.
- Be 18 years or older.
- Have a performance status score of 0 or 1, indicating full activity or some restriction in strenuous activities.
- Have adequate organ and bone marrow function as shown by specific blood tests.
- Have a cardiac function assessment if there is a history of heart disease.
- Agree to use effective contraception during the study and for a specified period after treatment.
- Be able to understand and sign a written informed consent document.
Exclusion Criteria
- Have cancer in the sinonasal, nasopharyngeal, or skin areas.
- Have cancer that has spread to distant parts of the body, including the brain.
- Have received chemotherapy or radiotherapy for head and neck cancer within the last 6 months.
- Have previously received certain types of immunotherapy.
- Have received a live vaccine within 30 days before starting the study.
- Be participating in another clinical trial or have used an investigational device recently.
- Have an immunodeficiency or be on long-term steroid therapy.
- Have another active cancer that required treatment in the last 2 years.
- Have a history of severe allergic reactions to study drugs.
- Have an active autoimmune disease requiring treatment in the last 2 years.
- Have a history of lung disease requiring steroids.
- Have an active infection needing treatment.
- Have a history of HIV or active hepatitis B or C.
- Have any condition that might interfere with the study.
- Have psychiatric or substance abuse issues affecting participation.
- Have not recovered from side effects of previous cancer treatment.
- Have had an organ transplant.
- Be pregnant or breastfeeding.
Get This Program In Your Inbox
Receive detailed information about this treatment opportunity to review with your healthcare provider.