KEYSTROKE: A Randomized Phase II Study of Pembrolizumab (KEYTRUDA) Plus Stereotactic Re-Irradiation Versus SBRT Alone for Locoregionally Recurrent or Second Primary Head and Neck Carcinoma

Protocol No

In this study we want to find out more about whether adding pembrolizumab (study drug) to radiation (the usual approach for your cancer) is safe and tolerable in patients with head and neck cancer. The study drug can help the immune system recognize cancer cells and is already FDA-approved for treating patients with head and neck cancer that has come back or spread. However, the study drug along with radiation therapy is not part of the usual treatment of head and neck cancer. The use of the study drug in this study is considered investigational. An investigational use is one that is not approved by the FDA.
If the addition of the study drug is safe and tolerable, the second part of the study will compare any good and bad effects of using the study drug plus radiation therapy to using radiation therapy alone. The addition of the study drug to radiation could shrink your cancer/prevent it from returning but it could also cause side effects.
This part of the study will allow the researchers to know whether this different approach is better, the same, or worse than the usual approach. To be better, the study approach should improve survival compared to the usual approach

SBRT +/- Pembrolizumab in Patients w/ Local-Regionally Recurrent or 2nd Primary Head and Neck Cancer
Participating Institutions
Froedtert Hospital