OncoMatch/Clinical Trials/NCT05307939
A Study on Using Cell-Free Tumor DNA (ctDNA) Testing to Decide When to StartRoutine Treatment in People With Human Papilloma Virus (HPV)- Associated Oropharynx Cancer (OPC)
Is NCT05307939 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies Chemoradiation (Arm B) for hpv.
Treatment: Chemoradiation (Arm B) — This study will look at whether monitoring HPV ctDNA levels is an effective way to detect cancer relapse risk in people with HPV-OPC. All participants will have recently had surgery to treat their disease, or they will be scheduled to have this surgery. In Arm A the researchers will see whether monitoring participants' HPV ctDNA levels can safely identify patients who do not need radiation therapy (RT) after surgery and whose RT can be delayed until their HPV ctDNA levels become detectable. In Arm B, the researchers will see whether patients who usually need 6-6.5 weeks of CRT can be selected by HPV ctDNA to receive 3 weeks of CRT.
Check if I qualifyExtracted eligibility criteria
Cancer type
Head and Neck Squamous Cell Carcinoma
Biomarker criteria
Required: HPV16 HPV-16 positive by in-situ hybridization
HPV-16 squamous cell carcinoma of the oropharynx or HPV-16 head and neck squamous cell carcinoma of unknown primary . HPV status must be confirmed by in-situ hybridization.
Required: HPV16 ctDNA detectable by digital PCR (Naveris assay) with a minimum of 50 copies/mL pre-operatively (≥ 50 copies/mL)
HPV ctDNA detectable by HPV digital PCR (Naveris assay) with a minimum of 50 copies/mL pre-operatively.
Required: HPV16 ctDNA undetectable (<1 copy/mL) post-operatively (2 tests, 2-6 weeks after surgery, at least 1 week apart preferred) (<1 copy/mL)
Two, undetectable (<1 copy/mL) post-operative HPV ctDNA within 2-6 weeks following surgery (blood drawn at least one week apart preferred).
Disease stage
Required: Stage PT0N1-N2B, PT1N1, PT2N1, ≥PT3, ≥PN2 (AJCC 7)
Excluded: Stage METASTATIC DISEASE
AJCC 7 Stage: pT0N1-N2b, pT1N1, pT2N1, or ≥pT3; AJCC 7 ≥pN2; metastatic disease [excluded]
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Must have received: surgical resection — all gross disease
Surgical resection of all gross disease with no gross disease visualized on post-operative imaging.
Cannot have received: head and neck radiation
Prior head and neck radiation
Cannot have received: systemic chemotherapy for the study cancer
Exception: prior chemotherapy for a different cancer is allowable
Prior systemic chemotherapy for the study cancer
Lab requirements
Blood counts
WBC ≥ 2 K/mcL; ANC ≥ 1,000 cells/mm3; Platelets ≥ 100,000 cells/mm3; Hemoglobin ≥ 8.0 g/dl (transfusion/intervention allowed)
Kidney function
Serum creatinine < 1.5 mg/dl or creatinine clearance (CC) ≥ 50 ml/min
Liver function
Bilirubin < 2 mg/dl; AST or ALT < 3 x the upper limit of normal
Adequate hematologic, renal, and hepatic function within 30 days prior to registration
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Baptist Alliance MCI (Data Collection Only) · Miami, Florida
- Memorial Sloan Kettering Basking Ridge (Limited protocol activities) · Basking Ridge, New Jersey
- Memorial Sloan Kettering Monmouth (Limited Protocol Activities) · Middletown, New Jersey
- Memorial Sloan Kettering Bergen (Limited Protocol Activities) · Montvale, New Jersey
- Memorial Sloan Kettering Suffolk-Commack (Limited Protocol Activities) · Commack, New York
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
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