CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 48 enrolled
Drug / intervention
MK-3475 +1 moredrug
Likely dose
MK-3475 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/NCT02289209
NCT02289209Phase 2Completed

A Phase II Trial of Reirradiation Combined With Open Label Pembrolizumab in Patients With Locoregional Inoperable Recurrence or Second Primary Squamous Cell Carcinoma of the Head and Neck (SCCHN)

Dan Zandberg·interventional·Posted Nov 13, 2014·Updated Mar 6, 2025

In Brief

A Phase 2 clinical trial evaluating Reirradiation and MK-3475 for Recurrent Head and Neck Cancer and Carcinoma, Squamous Cell of Head and Neck. Completed, enrolled 48 participants across 4 sites.

Detailed Summary

Eligible participants with locoregional inoperable recurrence or second primary squamous cell carcinoma of the head and neck will be treated with reirradiation combined with anti-PD-1 mAb MK-3475 (generic name: pembrolizumab, trade name Keytruda®).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

Phase 2CompletedFinished
201520162017201820192020202120222023202420252026
First PostedNov 13, 2014
Enrollment StartMar 9, 2016
Primary CompletionAug 31, 2023
Study CompletionAug 31, 2024
TodayJul 2, 2026
Enrollment to primary: 7.5 yearsPosted 11.6 years ago

Interventions

Reirradiationradiation

Reirradiation 1.2 GY BID 5 days a week for 5 weeks.

MK-3475drug

MK-3475 will be given at 200mg intravenous every 3 weeks starting day one of reirradiation and will be continued once every 3 weeks until 3 months post completion of reirradiation. Further continuation of MK-3475 will be determined by response evaluation at 3 months post completion of reirradiation