At a glance
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Phase II Trial of Adjuvant De-Escalated Radiation + Concurrent and Adjuvant Nivolumab for Intermediate-High Risk P16+ Oropharynx Cancer
In Brief
A Phase 2 clinical trial evaluating Nivolumab Injection and Radiotherapy (RT) for Carcinoma, Squamous Cell of Head and Neck and Oropharynx Squamous Cell Carcinoma. Completed, enrolled 40 participants across 3 sites.
Detailed Summary
This clinical trial will evaluate a new combination of treatments for Oropharyngeal Squamous Cell cancers (OPSCC), and compare it to the current standard of care (concurrent, platinum-based chemoradiotherapy). Chemoradiotherapy is efficacious, but also associated with significant toxicities and is only suitable for patients with good performance status and without severe comorbidities. The purpose of this trial is to demonstrate equivalent oncologic outcome with fewer adverse effects and improved quality of life when compared to the standard of care.
Study Details
Timeline
Interventions
A fully human anti-programmed death 1 (PD-1) monoclonal antibody
45-50 Gy accelerated fractionation in 25 daily fractions, 6 fractions per week