At a glance
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Phase II Trial of Radiotherapy, Carboplatin/Paclitaxel and Nivolumab for High Risk HPV-Related Oropharynx Cancer
In Brief
A Phase 2 clinical trial evaluating Nivolumab, Carboplatin, and 2 other interventions for Oropharynx Squamous Cell Carcinoma. Completed, enrolled 26 participants across 1 site.
Detailed Summary
The purpose of this study is to find out if the addition of nivolumab can improve 2 year progression free survival (PFS) as compared to standard of care of fractionated radiation therapy (RT) and carboplatin/paclitaxel in subjects with high risk HPV-related squamous cell carcinoma of the oropharynx (tonsil, base of tongue, oropharyngeal wall, soft palate). Fractionated means the radiation will be administered in fragments or parts across multiple days.
Study Details
Timeline
Interventions
Given intravenously (IV), 240 mg every 2 weeks for 4 doses concurrent with radiation therapy (RT). Following completion of RT, 480 mg given every 4 weeks for 4 doses.
Given IV once per week during radiation therapy (AUC=1).
Given IV once per week during radiation therapy (30mg/m\^2)
Given 5 days/week for a total of 35 doses (70 gray total).