CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 172 enrolled
Drug / intervention
pembrolizumabbiological
Likely dose
Not stated in 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/NCT02255097
NCT02255097Phase 2Completed

A Phase II Clinical Trial of Single Agent Pembrolizumab (MK-3475) in Subjects With Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma (HNSCC) Who Have Failed Platinum and Cetuximab

Merck Sharp & Dohme LLC·interventional·Posted Oct 2, 2014·Updated Jun 28, 2022

In Brief

A Phase 2 clinical trial evaluating pembrolizumab for Head and Neck Squamous Cell Carcinoma. Completed, enrolled 172 participants.

Detailed Summary

This is a study of single-agent pembrolizumab (MK-3475) in participants with recurrent and/or metastatic head and neck squamous cell carcinoma (HNSCC) who have progressed on platinum-based and cetuximab therapy. The primary study hypothesis is that pembrolizumab will provide a clinically meaningful objective response rate (ORR). With protocol amendment 05 (02-Jan-2018), once study participants have achieved the study objective or the study has ended, participants will be discontinued from this study and enrolled in an extension study to continue protocol-defined assessments and treatment.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
Countries--
Collaborators--

Timeline

Phase 2CompletedFinished
201520162017201820192020202120222023202420252026
First PostedOct 2, 2014
Enrollment StartOct 24, 2014
Primary CompletionApr 22, 2016
Study CompletionJun 18, 2021
TodayJul 2, 2026
Enrollment to primary: 1.5 yearsPosted 11.8 years ago

Interventions

pembrolizumabbiological