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Preoperative Pembrolizumab and Chemotherapy in Resectable, Recurrent HNSCC

Head and Neck Cancer Clinical Trial

Official title:
A Phase 2 Study of Preoperative Pembrolizumab and Chemotherapy Followed by Adjuvant Pembrolizumab in Resectable Locoregionally Recurrent Head and Neck Squamous Cell Carcinoma

Clinical Trial Summary

This research study is evaluating effectiveness and safety of a combination of immunotherapy drug, pembrolizumab, with chemotherapy, as a possible treatment before and after surgery for squamous cell carcinoma of the head and neck (HNSCC). The combination of pembrolizumab and chemotherapy will be given prior to your surgery, while immunotherapy pembrolizumab will be continued for approximately 1 year after surgery. The names of the study drugs involved in this research study are: - pembrolizumab (a type of immunotherapy) - docetaxel (a type of chemotherapy) - cisplatin (a type of chemotherapy) - carboplatin (a type of chemotherapy)

Clinical Trial Description

This is a Phase II, open-label, non-randomized, single arm, single-center interventional study of neoadjuvant chemoimmunotherapy with pembrolizumab, cisplatin (or carboplatin), and docetaxel followed by salvage surgery followed by adjuvant pembrolizumab therapy in patients with resectable recurrent squamous cell carcinoma of the head and neck (HNSCC). Pembrolizumab works by helping the immune system to fight HNSCC. This research study involves screening for eligibility, study treatment visits including evaluations, radiologic scans, tumor biopsies, and blood tests. The U.S. Food and Drug Administration (FDA) has not approved Pembrolizumab for squamous cell carcinoma of the head and neck (HNSCC) setting before and after surgery, but it has been approved for HNSCC in the advanced incurable setting when surgery is no longer possible or cancer has spread to parts of the body outside the head and neck region. All other drugs used in this study have been approved by the FDA for squamous cell carcinoma of the head and neck (HNSCC) in the advanced incurable setting. Participation in this research study is expected to last for up to 5 years. It is expected that about 28 people will take part in this research study. Merck Sharp & Dohme LLC is supporting this research study and providing the study drug. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05726370
Study type Interventional
Source Dana-Farber Cancer Institute
Contact Kartik Sehgal, MD
Phone 617-582-7322
Email kartik_sehgal@dfci.harvard.edu
Status Recruiting
Phase Phase 2
Start date May 20, 2023
Completion date May 20, 2030
View Details
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