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Radiotherapy, Carboplatin/Paclitaxel and Nivolumab for High Risk HPV-related Head and Neck Cancer

Oropharynx Squamous Cell Carcinoma Clinical Trial

Official title:
Phase II Trial of Radiotherapy, Carboplatin/Paclitaxel and Nivolumab for High Risk HPV-Related Oropharynx Cancer

Clinical Trial 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.

Clinical Trial Description

PCD details were updated as RECIST is not appropriate for tumor response assessment in this population. Tumor response will be assessed via clinical assessment and PET response (determining progression and location, if any evidence of disease). ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03829722
Study type Interventional
Source University of Michigan Rogel Cancer Center
Contact
Status Active, not recruiting
Phase Phase 2
Start date September 5, 2019
Completion date September 2024
View Details
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