Neoplasms

All Conditions

Symptoms and General Pathology

Mouth and Tooth Diseases

Ear, Nose, and Throat Diseases

Rare Diseases

Carcinoma

Carcinoma, Squamous Cell

Neoplasm Metastasis

Recurrence

Head and Neck Neoplasms

Mouth Neoplasms

Squamous Cell Carcinoma of Head and Neck

Oropharyngeal Neoplasms

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Neoplasms, Squamous Cell

Neoplastic Processes

Disease Attributes

Pharyngeal Neoplasms

Otorhinolaryngologic Neoplasms

Pharyngeal Diseases

Stomatognathic Diseases

Otorhinolaryngologic Diseases

Mouth Diseases

Oral Cancer

Lip and Oral Cavity Cancer

Antineoplastic Agents

All Drugs and Chemicals

Pembrolizumab

Cisplatin

Immunomodulating Agents

Antineoplastic Agents, Immunological

Immune Checkpoint Inhibitors

Intensity-modulated radiation therapy to 70 Gy in 33-35 fractions over 6.5 weeks plus concurrent cisplatin 100 mg/m2 every 3 weeks for 3 cycles (7 weeks)

Intensity-modulated radiation therapy to 70 Gy in 33-35 fractions over 6.5 weeks plus concurrent and adjuvant pembrolizumab 200 mg IV infusion every 3 weeks x 20 cycles

Pembrolizumab 200 mg IV infusion every 3 weeks x 20 cycles

Radiation therapy

Loren Mell, MD

Gerald Henderson

Alysha Zeoli

Ricklie Julian, MD

Khushbu Singh, MBBS, CCRP

Jennifer Pope, CCRP

Melissa Young, MD, PhD

Elisa Lemerond

Jimmy Caudell, MD

Melissa Butler

Douglas Adkins, MD

Aubrey Hamilton

Sarah Wilson

Trisha Wise-Draper, MD, PhD

Kathy Taylor

Mike Gibson, MD

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).

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).

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)

compare the outcomes with RT/pembrolizumab in patients with tumors as a function of PD-L1 expression.

time from randomization to progression/relapse or death from any cause.

time from randomization to death from any cause

Toxicities due to therapy occurring within 3 months of therapy completion based on CTCAE criteria using questionnaires

Toxicity due to therapy occurring greater than 3 months after completion of therapy based on CTCAE criteria using questionnaires

Local and regional and distant recurrence of cancer and causes of death from competing events

Merck Sharp & Dohme LLC

Director, Division of Clinical and Translational Research/ Department of Radiation Medicine

Spots Global Cancer Trial Database for oropharynx cancer, recurrent