Pembrolizumab in Combination With CRT for LA-SCCHN
Status:
Active, not recruiting
Trial end date:
2023-09-01
Target enrollment:
Participant gender:
Summary
This is a single-arm, multi-site, open-label trial of pembrolizumab (MK-3475) used in
combination with standard, cisplatin-based, definitive chemoradiotherapy (CRT) in patients
with stage III-IVB squamous cell carcinoma of the head and neck (SCCHN). Approximately 39
patients with Stage III-IVB SCCHN will be enrolled to evaluate both the safety and efficacy
of this novel combination. Subjects will not be randomized and will all receive the study
treatment.
Treatment will consist of a loading dose of pembrolizumab 200 mg IV given 7 days prior to
initiation of CRT (day-7). CRT with cisplatin 40 mg/m2 IV weekly and head and neck radiation
at 70 Gy fractionated at 2 Gy once daily over 35 days, will begin on day 1. CRT will end on
approximately day 46-50. Pembrolizumab 200 mg IV will continue following CRT in an adjuvant
fashion starting on day 57 for an additional 5 doses, as tolerated, through day 141. Subjects
will be evaluated for response following treatment.