A Phase II Trial of Reirradiation Combined with Open Label Pembrolizumab in Patients with Locoregional Inoperable Recurrence or Second Primary Squamous Cell Carcinoma of the Head and Neck (SCCHN)
Ana Ponce Kiess
Johns Hopkins Kimmel Cancer Center in Baltimore
The purpose of the study is to test the combination of a drug called MK-3475 and reirradiation in people with SCCHN. This study is being done to see if this new combination can improve outcomes for your cancer. Studies in animals and humans suggest that MK-3475 may increase the immune system’s response to certain types of cancers, including SCCHN. This could impact length of survival. Studies in animals suggest that giving radiation and a drug that works like MK-3475 causes the immune system to attack cancer more than giving radiation or the drug alone. Therefore, the purpose of this study is to evaluate the safety and effectiveness of MK-3475 and radiation in people with SCCHN. This will be the first time the combination of radiation and MK-3475 has been tested in humans.
Patients with biopsy proven locoregional recurrence or second primary SCCHN in a previously radiated field which is unresectable or the patient is unwilling to undergo resection. Determination of unresectability will be based on multidisciplinary review of each case.
Each patient will undergo screening and then be treated with reirradiation with 1.2 Gy BID, 5 days a week (weeks 1-5). MK-3475 will be given at 200mg intravenous every 3 weeks starting day one of reirradiation and will be continued in all patients until 3 months post completion of reirradiation, at which time a PET/CT will be done to evaluate response. Patients with progressive disease will be taken off the study. Patients that have a complete response will be followed clinically and radiographically, and if disease recurs may be eligible to be retreated with MK-3475 for up to one year. Patients with partial response (PR) or stable disease (SD) will continue treatment with MK-3475 for up to two years. Patients who have not progressed at completion of 24 months of therapy will be observed, but may be eligible for 1 year of retreatment with MK-3475 if they develop recurrence/progression if they qualify as detailed in the protocol and if the trial is still ongoing.
03/05/2019 05:03 AM