NCT04900623 Risk-adapted Therapy in HPV+ Oropharyngeal Cancer Using Circulating Tumor (ct)HPV DNA Profile - The ReACT Study

Trial Parameters

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Brief Summary

This research is being conducted to understand if treatment can be tailored for participants with HPV-related oropharynx cancers using both clinical features (stage of the tumor, smoking status) combined with an investigational HPV blood test. The names of the test and treatments involved in this study are: * NavDx® HPV ctDNA testing (HPV blood test) * Radiation therapy * Chemotherapy: Cisplatin, or Carboplatin and Paclitaxel (not all participants receive any or all of these agents)

Eligibility Criteria

Inclusion Criteria: * Participants must meet the following eligibility criteria at the time of screening to be eligible to participate in the study: * Subject must have histologically or cytologically confirmed, stage I, II, or III (N3 disease excluded), HPV associated oropharyngeal (tongue base or tonsil) squamous cell carcinoma, as defined by 2017 American Joint Committee on Cancer (AJCC), 8th edition staging. \-- Patients with HPV-associated disease of unknown primary (cT0) are eligible * HPV status should be confirmed on tissue biopsy or cytologic sample by any of the following: * Immunohistochemical staining for p16 with ≥70% expression * Confirmatory DNA testing (PCR or ISH) for high-risk subtype * Willing to provide blood and tissue from a diagnostic biopsy and blood samples before, during, and after treatment. * Detectable HPV ctDNA blood sample at baseline, prior to treatment, using the NavDx® assay that detects HPV subtype 16 * Age 22 years or older * ECOG performance status

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