Pembrolizumab in Combination With Cisplatin and Intensity Modulated Radiotherapy (IMRT) in Head and Neck Cancer

PHASE2CompletedINTERVENTIONAL
Enrollment

80

Participants

Timeline

Start Date

May 31, 2016

Primary Completion Date

April 24, 2023

Study Completion Date

May 4, 2023

Conditions
Head and Neck Squamous Cell Carcinoma
Interventions
DRUG

Pembrolizumab

In both arms, the dose of pembrolizumab will be 200 mg (fixed dose) intravenous (IV) every 3 weeks for a total of 8 doses. In Arm 1, pembrolizumab will begin in week 10 of treatment, after cisplatin-IMRT is complete. In Arm 2, pembrolizumab will begin the week before cisplatin-IMRT.

DRUG

Cisplatin

Patients will receive cisplatin once weekly as an IV infusion over 60 minutes, for a total of 7 doses, at the same time as radiation.

RADIATION

IMRT

IMRT will be delivered in 35 fractions (treatments) over 7 weeks (five treatments per non-holiday week) in one plan.

Trial Locations (1)

15232

UPMC Hillman Cancer Center, Pittsburgh

All Listed Sponsors
collaborator

Merck Sharp & Dohme LLC

INDUSTRY

lead

Dan Zandberg

OTHER

NCT02777385 - Pembrolizumab in Combination With Cisplatin and Intensity Modulated Radiotherapy (IMRT) in Head and Neck Cancer | Biotech Hunter | Biotech Hunter