RecruitingPhase 2NCT05726370

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

Sponsor

Dana-Farber Cancer Institute

Enrollment

28 participants

Start Date

May 20, 2023

Study Type

INTERVENTIONAL

Conditions

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

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)

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether giving immunotherapy (pembrolizumab) together with chemotherapy before surgery can improve outcomes for people with head and neck squamous cell cancer that has come back in an area that was previously treated with radiation. **You may be eligible if...** - You have confirmed squamous cell cancer of the head and neck (mouth, throat, larynx) that has recurred locally or is a second cancer in a previously irradiated area - Your cancer can potentially be surgically removed with the goal of cure - At least 6 months have passed since your last cancer treatment **You may NOT be eligible if...** - Your cancer cannot be surgically removed - You have serious autoimmune conditions or are on immunosuppressant medications - You have active infections or conditions that make chemotherapy unsafe Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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