A Phase 2 Study of Pembrolizumab Compared to the Usual Treatment of Chemotherapy With Radiation Given After Surgery for Recurrent or Second Primary Head and Neck Cancer

Full Title

A Phase II Randomized Trial of Adjuvant Therapy with Pembrolizumab After Resection of Recurrent/Second Primary Head and Neck Squamous Cell Carcinoma with High Risk Features (EA3191) (CIRB)

Purpose

Researchers are comparing pembrolizumab given after surgery for head and neck cancer with the usual treatment. The usual therapy includes chemotherapy and radiation therapy. The people in this study have head and neck cancer that came back or is a new primary cancer.

Pembrolizumab is an immunotherapy drug. It takes the brakes off the immune response so the immune system can find and kill cancer cells. It is given intravenously (by vein).

If you take part in this study, you will be randomly assigned to one of these treatments after surgery:

• Cisplatin or carboplatin (given intravenously) with radiation therapy.
• Pembrolizumab alone.

Who Can Join

To join this study, there are a few conditions. You must:

• Have recurrent or a second primary head and neck cancer that has not metastasized (spread).
• Have surgery for head and neck cancer within 8 weeks of starting the study therapy.
• Have a tumor that is positive for the PD-L1 protein (the target of pembrolizumab).
• Have had prior radiation therapy for this head and neck cancer.
• Not have had prior immunotherapy for recurrent disease.
• Be well enough to walk and take care of yourself. You must be able to do activities such as office work or light housework.
• Be age 18-79.

Contact

For more information or to see if you can join this study, please call Dr. Michael Hwang’s office at 646-608-3793.