CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 18 enrolled
Drug / intervention
Pembrolizumab +1 moredrug
Likely dose
Pembrolizumab 200mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03057613
NCT03057613Phase 2Completed
CompareCT.gov

A Phase II Study of the Addition of Pembrolizumab to Postoperative Radiotherapy in Resected High Risk Cutaneous Squamous Cell Cancer of the Head and Neck

Case Comprehensive Cancer Center·interventional·Posted Feb 20, 2017·Updated Jun 30, 2022

In Brief

A Phase 2 clinical trial evaluating Pembrolizumab and IMRT 60-66Gy for Squamous Cell Carcinoma of the Head and Neck. Completed, enrolled 18 participants across 2 sites.

Detailed Summary

A small group of skin cancers of the head and neck, called resected cutaneous squamous carcinomas, are more aggressive than most cancers of this type, even after being treated with standard therapy. This trial will use stronger treatment to look at the safety and effectiveness (efficacy) of combining a drug called Pembrolizumab with radiation after a cancer has already been treated to suppress secondary tumor formation in high risk cutaneous squamous cell cancer of the head and neck. Primary Objective To assess safety by looking at the people with dose limiting responses

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSquamous Cell Carcinoma of the Head and Neck
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
2017201820192020202120222023202420252026
First PostedFeb 20, 2017
Enrollment StartMay 10, 2017
Primary CompletionJun 26, 2020
Study CompletionSep 9, 2020
TodayJul 2, 2026
Enrollment to primary: 3.1 yearsPosted 9.4 years ago

Interventions

Pembrolizumabdrug

200mg every 3 weeks for 16 weeks given by IV infusion

IMRT 60-66Gyradiation

60-66Gy for 6 weeks