NCT03383094

Chemoradiation vs Immunotherapy and Radiation for Head and Neck Cancer

Phase II Randomized Trial of Radiotherapy With Concurrent and Adjuvant Pembrolizumab (Keytruda®) Versus Concurrent Chemotherapy in Patients With Advanced/Intermediate-Risk p16+ Head and Neck Squamous Cell Carcinoma (KEYCHAIN)

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 126 (actual)
• Sponsor: Loren Mell, MD · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Detailed description

This study is a prospective, multi-institutional, open-label, randomized phase II trial that will evaluate the efficacy of concurrent and adjuvant pembrolizumab with radiation therapy (RT) versus RT plus cisplatin in intermediate/high-riskp16-positive locoregionally advanced head and neck squamous cell carcinoma (HNSCC). The primary endpoint is progression-free survival (PFS).

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

Type	Name	Description
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.

Timeline

• Start date: 2018-03-15
• Primary completion: 2026-12-31
• Completion: 2027-12-31
• First posted: 2017-12-26
• Last updated: 2025-10-07

Locations

6 sites across 1 country: United States

Regulatory

• FDA-regulated drug study