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Chemoradiation vs Immunotherapy and Radiation for Head and Neck Cancer

NCT03383094 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 126

Last updated 2025-10-07

No results posted yet for this study

Summary

The purpose of this study is to compare any good or bad effects of using pembrolizumab (an experimental drug) and radiation therapy (RT), compared to using cisplatin chemotherapy and radiation therapy (RT) in the treatment of patients with head and neck squamous cell carcinoma (HNSCC).

Conditions

  • Head and Neck Squamous Cell Carcinoma
  • Cancer
  • Cancer of Head and Neck
  • Cancer, Advanced
  • Cancer, Metastatic
  • Tumor
  • Tumor Recurrence
  • Tumor Neck
  • Tumor Metastasis
  • Oral Cancer
  • Oropharyngeal Cancer
  • Oropharynx Cancer
  • Oropharynx Cancer, Stage III
  • Oropharynx Cancer, Recurrent
  • Oropharynx Cancer, Metastatic

Interventions

DRUG

Pembrolizumab

Pembrolizumab 200 mg IV infusion every 3 weeks x 20 cycles

RADIATION

Radiation therapy

70 Gy in 33-35 fractions

DRUG

Cisplatin

100 mg/m2 Weeks 1, 4, and 7.

Sponsors & Collaborators

Principal Investigators

  • Loren Mell, MD · University of California, San Diego

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-03-15
Primary Completion
2026-12-31
Completion
2027-12-31
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 NCT03383094 on ClinicalTrials.gov