MedTrace Logo

Immunotherapy With MK-3475 in Surgically Resectable Head and Neck Squamous Cell Carcinoma

NCT02296684 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 67

Last updated 2026-05-08

Study results available
· View outcomes & findings →

Summary

The goal of this trial is to test the ability of MK-3475 (pembrolizumab) to improve locoregional recurrence and distant metastatic rates in high-risk patients with locally advanced head and neck squamous cell carcinomas (HNSCCs) that are treated with current standard of care surgical approaches.

Conditions

  • Cancer of Head and Neck
  • Head and Neck Cancer
  • Neoplasms, Head and Neck
  • Carcinoma, Squamous Cell of Head and Neck
  • Squamous Cell Carcinoma of the Head and Neck
  • Squamous Cell Carcinoma, Head and Neck

Interventions

BIOLOGICAL

MK-3475 (neoadjuvant)

PROCEDURE

Surgery

Standard of care

RADIATION

Intensity modulated radiation therapy

Recommended, standard of care

RADIATION

Image-guided radiation therapy

Recommended, standard of care

DRUG

Cisplatin

Standard of care

BIOLOGICAL

MK-3475 (adjuvant)

PROCEDURE

Peripheral blood

-Baseline, time of surgery (between day 14-24 inclusive), 3 months post surgery, 6 months post surgery, 9 months post surgery, 12 months post surgery

Sponsors & Collaborators

Principal Investigators

  • Douglas R Adkins, M.D. · Washington University School of Medicine

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-03-25
Primary Completion
2022-04-05
Completion
2025-07-21
FDA Drug
Yes

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 NCT02296684 on ClinicalTrials.gov