About this trial
This study looks at how well the drug pembrolizumab works by itself after surgery compared to the usual treatment of chemotherapy and radiation in patients with recurrent head and neck squamous cell carcinoma. The goal is to see which approach helps patients live longer and have fewer issues with the cancer coming back. It involves patients who have had surgery for their cancer that has returned or for a new cancer that started in the head and neck area.
The trial's ID number is NCT04671667. It is a Phase 2 trial, which means it is looking at how well the treatment works and how safe it is. The trial is FDA-regulated and hopes to include about 188 participants.
Who can join
This trial is open to adults aged 18 to 79, both men and women. Participants must have had surgery for recurrent or new head and neck cancer and be within 8 weeks of that surgery. They should have high-risk features, such as positive margins or certain tumor characteristics. Patients cannot have other serious diseases and must not be pregnant or breastfeeding. The trial team will confirm each person's eligibility before they can join.
Conditions
Recurrent Head and Neck Squamous Cell Carcinoma, Recurrent Hypopharyngeal Squamous Cell Carcinoma, Recurrent Laryngeal Squamous Cell Carcinoma, Recurrent Oral Cavity Squamous Cell Carcinoma, Recurrent Oropharyngeal Squamous Cell Carcinoma
Age group
Adult, Older adult
The study team makes the final call on eligibility.
What happens in the study
Participants will be placed into one of two groups by chance. One group will receive chemotherapy (cisplatin or carboplatin) and radiation therapy. The other group will receive only pembrolizumab. Everyone will have regular imaging tests to monitor their condition throughout the trial. Each treatment lasts for several cycles, with follow-up care after the treatments are completed.
Where
This trial is running at 178 locations in the United States. 130 of them are currently recruiting.
Annie Penn Memorial Hospital
Reidsville, North Carolina
Aspirus Cancer Care - Stevens Point
Stevens Point, Wisconsin
Aspirus Cancer Care - Wisconsin Rapids
Wisconsin Rapids, Wisconsin
Aspirus Cancer Care-Antigo-Volm Cancer Center
Antigo, Wisconsin
Aspirus Cancer Care-Rhinelander-James Beck Cancer Center
Rhinelander, Wisconsin
Aspirus Cancer Care-Wausau
Wausau, Wisconsin
Atrium Medical Center-Middletown Regional Hospital
Franklin, Ohio
Avera Cancer Institute
Sioux Falls, South Dakota
The first 8 of 178 sites are listed here. The registry record has the full list.