NCT05726370

Preoperative Pembrolizumab and Chemotherapy in Resectable, Recurrent HNSCC

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

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 28 (estimated)
• Sponsor: Dana-Farber Cancer Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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)

Detailed 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 surgery followed by adjuvant pembrolizumab therapy in patients with resectable recurrent squamous cell carcinoma of the head and neck (HNSCC). This study will also include individuals with new HNSCC which developed in a field that has received prior radiation therapy. 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.

Conditions

• Head and Neck Squamous Cell Carcinoma
• Head and Neck Cancer
• Resectable Head and Neck Squamous Cell Carcinoma
• Recurrent Head and Neck Squamous Cell Carcinoma
• Second Primary Squamous Cell Carcinoma of the Head and Neck

Interventions

Type	Name	Description
DRUG	Pembrolizumab	Immunoglobulin G4 monoclonal antibody, via IV infusion
DRUG	CISPLATIN	Platinum agent, via IV infusion
DRUG	Carboplatin	Platinum agent, via IV infusion
DRUG	Docetaxel	Antineoplastic agent, via IV infusion.

Timeline

• Start date: 2023-05-20
• Primary completion: 2027-12-31
• Completion: 2030-05-20
• First posted: 2023-02-13
• Last updated: 2025-06-22

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study