MedTrace Logo

Phase II Trial of Adjuvant Cisplatin and Radiation With Pembrolizumab in Resected Head and Neck Squamous Cell Carcinoma

NCT02641093 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 96

Last updated 2026-05-04

Study results available
· View outcomes & findings →

Summary

The purpose of this research study is to test the safety and the benefit of adding pembrolizumab (a therapy that activates the immune system to fight cancer) to standard of care treatment for head and neck cancer. The standard of care treatment will include surgery followed by radiation for 6 weeks. Some patients may also receive cisplatin as standard of care once a week for 6 weeks if the cancer is found to be "high risk". High risk includes cancer that was not completely removed (positive margins) or cancer that has invaded through the outer lining of your lymph nodes.

Conditions

Interventions

DRUG

Pembrolizumab

Pembrolizumab administered one week prior to surgery and then every three weeks in the adjuvant setting for a total of 7 doses.

PROCEDURE

Surgery

gross total surgical resection

RADIATION

Radiation Therapy

60-66 Gy over 6 weeks

DRUG

Cisplatin

Weekly during radiation therapy for 6 doses only for patients with high risk pathological features

Sponsors & Collaborators

Principal Investigators

  • Trisha Wise-Draper, MD, PhD · University of Cincinnati

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-01-31
Primary Completion
2021-04-16
Completion
2026-11-02

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02641093 on ClinicalTrials.gov