OncoMatch/Clinical Trials/NCT04900623
Risk-adapted Therapy in HPV+ Oropharyngeal Cancer Using Circulating Tumor (ct)HPV DNA Profile - The ReACT Study
Is NCT04900623 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including NavDx HPV ctDNA Testing and Chemotherapy drug for hpv-associated oropharyngeal squamous cell carcinoma.
Treatment: NavDx HPV ctDNA Testing · Chemotherapy drug — 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)
Check if I qualifyExtracted eligibility criteria
Cancer type
Head and Neck Squamous Cell Carcinoma
Biomarker criteria
Required: HPV high-risk subtype
Confirmatory DNA testing (PCR or ISH) for high-risk subtype
Required: CDKN2A p16 overexpression (≥70%)
Immunohistochemical staining for p16 with ≥70% expression
Required: HPV 16 (detectable)
Detectable HPV ctDNA blood sample at baseline, prior to treatment, using the NavDx® assay that detects HPV subtype 16
Disease stage
Required: Stage I, II, III
Excluded: Stage IVC
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Cannot have received: radiation therapy
Subject who has had prior radiation and/or chemotherapy for head and neck cancer
Cannot have received: chemotherapy
Subject who has had prior radiation and/or chemotherapy for head and neck cancer
Cannot have received: oncologic surgical resection or neck dissection
Exception: prior tonsillectomy as part of identification of the primary tumor site or biopsy and excisional nodal biopsy is/are acceptable provided the patient would be standardly treated to definitive treatment doses of therapy off protocol. Patients with HPV-associated unknown primary should not have undergone a neck dissection to be eligible.
Any history of oncologic surgical resection (transoral robotic surgery, TORS) or oncologic neck dissection prior to undergoing definitive RT or chemoradiation.
Lab requirements
Blood counts
absolute neutrophil count (ANC) ≥ 1000; platelet count ≥ 100,000
Kidney function
creatinine of 1.6 or less (or a CrCl ≥50 mL/min) per institutional standards
Liver function
total bilirubin of 1.5 or less
Participants should have adequate organ and marrow function if they are to receive chemotherapy (cisplatin, or carboplatin and paclitaxel) with radiation concurrently as determined by standard institutional guidelines and investigator preference (parameters suggested below).
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Brigham and Women's Hospital · Boston, Massachusetts
- Dana Farber Cancer Institute · Boston, Massachusetts
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
Could you qualify for this trial?
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