Spots Global Cancer Trial Database for Radiotherapy, Carboplatin/Paclitaxel and Nivolumab for High Risk HPV-related Head and Neck Cancer
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Trial Identification
Brief Title: Radiotherapy, Carboplatin/Paclitaxel and Nivolumab for High Risk HPV-related Head and Neck Cancer
Official Title: Phase II Trial of Radiotherapy, Carboplatin/Paclitaxel and Nivolumab for High Risk HPV-Related Oropharynx Cancer
Study ID: NCT03829722
Conditions
Study Description
Brief 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.
Detailed 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).
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
University of Michigan Rogel Cancer Center, Ann Arbor, Michigan, United States
Contact Details
Name: Michelle Mierzwa, M.D.
Affiliation: University of Michigan Rogel Cancer Center
Role: PRINCIPAL_INVESTIGATOR
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