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Completed PHASE2 INTERVENTIONAL NCT02609503

Pembrolizumab + Radiation for Locally Adv SCC of the Head and Neck (SCCHN) Not Eligible Cisplatin

View on ClinicalTrials.gov Updated Dec 15, 2025

Brief Summary

This study is being done to evaluate the efficacy of Pembrolizumab, concomitant with and following standard of care definitive radiation, for locally advanced squamous cell carcinoma of the head and neck patients who are not good candidates for Cisplatin.

Detailed Description

This open label, phase II trial will enroll 29 subjects in order to evaluate the efficacy of Pembrolizumab, concomitant with and following standard of care definitive radiation for locally advanced squamous cell carcinoma head and neck patients who are not good candidates for Cisplatin. Objectives include estimating progression free survival and overall survival, response rates, safety and toxicity, and quality of life in these patients. Correlative studies, based on serial blood collections and tumor samples, may be done under a separate protocol based on availability of archival diagnostic tissue.

Interventions

Name: Pembrolizumab
Type: DRUG
Description: Pembrolizumab, 200 mg IV during cycle visits every 3-weeks for up to 6 cycles, or until toxicities are no longer tolerable
Name: Intensity Modulated Radiation Therapy
Type: RADIATION
Description: Eligible participants will receive Intensity Modulated Radiation Therapy daily x 7 weeks

Primary Outcomes

Measure: 20 Week Progression Free Survival Rate
TimeFrame: 20 weeks after D1 of treatment
Description: the proportion of patients who are alive and free of progression from disease at 20 weeks from the start of treatment
Measure: One Year Progression Free Survival Rate
TimeFrame: 1 years after D1 of treatment
Description: the proportion of patients who are alive and free of progression from disease atoneyears from the start of treatment
Measure: Two Year Progression Free Survival Rate
TimeFrame: 2 years after D1 of treatment
Description: the proportion of patients who are alive and free of progression from disease at two years from the start of treatment
Measure: Median Progression Free Survival
TimeFrame: up to 5 years after D1 of treatment
Description: Progression-free survival is defined as the time from D1 of treatment to progression or death from any cause. The median was not reached, thus Kaplan Meier's estimated rate at 5 years is reported.

Trial Information

NCT ID

NCT02609503

Status

Completed

Study Type

INTERVENTIONAL

Phases

PHASE2

Sponsor

UNC Lineberger Comprehensive Cancer Center

Last Updated

December 15, 2025