A Phase I and Expansion Cohort Study of Adjuvant Cisplatin, Intensity-Modulated Radiotherapy, and MK-3475 (Pembrolizumab) in High-Risk Head and Neck Squamous Cell Carcinoma (HNSCC)
Principal Investigator
,
Status
Terminated
Date Opened To Accrual
November 28 2016
Date Closed to Accrual
October 04 2018
Date of Study Termination
May 20 2022
Disease Site
Head and Neck [HN]
Head and Neck
Phase
I
Developmental Therapeutics
Yes
Primary Objective
To determine the recommended phase II schedule for the combination of MK-3475 (pembrolizumab) and standard, adjuvant cisplatin-radiotherapy in patients with high-risk, HPV-negative head and neck squamous cell carcinoma, based upon dose-limiting toxicity.
Patient Population
Patients with stage III-IVb, high-risk squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx, or larynx; patients with oropharyngeal cancer must be p16-negative.
Target Accrual
56