NCT02641093View on ClinicalTrials.gov

Phase II Trial of Adjuvant Cisplatin and Radiation With Pembrolizumab in Resected Head and Neck Squamous Cell Carcinoma

PHASE2Active, not recruitingINTERVENTIONAL
Enrollment

96

Participants

Timeline

Start Date

January 31, 2016

Primary Completion Date

April 16, 2021

Study Completion Date

November 2, 2025

Conditions
Head and Neck Cancer
Interventions
DRUG

Pembrolizumab

Pembrolizumab administered one week prior to surgery and then every three weeks in the adjuvant setting for a total of 7 doses.

PROCEDURE

Surgery

gross total surgical resection

RADIATION

Radiation Therapy

60-66 Gy over 6 weeks

DRUG

Cisplatin

Weekly during radiation therapy for 6 doses only for patients with high risk pathological features

Trial Locations (6)

29425

Medical University of South Carolina, Charleston

40202

University of Louisville - James Graham Brown Cancer Center, Louisville

43210

Ohio State University, Columbus

45219

University of Cincinnati Medical Center, Cincinnati

48109

University of Michigan, Ann Arbor

77030

MD Anderson Cancer Center, Houston

All Listed Sponsors
collaborator

Merck Sharp & Dohme LLC

INDUSTRY

lead

Trisha Wise-Draper

OTHER