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Study on Using ctDNA Testing for HPV-Associated Oropharynx Cancer

This study is looking at whether a blood test called HPV ctDNA (cell-free tumor DNA) can help doctors decide when to start routine treatment for people with HPV-associated oropharynx cancer (OPC). All participants will have recently had surgery or are scheduled for surgery. The study will use an HPV ctDNA Assay called NavDx to measure HPV ctDNA levels. In one group, researchers will see if monitoring these levels can safely identify patients who can delay radiation therapy (RT) after surgery. In another group, they will see if patients who usually need 6-6.5 weeks of chemoradiation therapy (CRT) can receive a shorter 3-week course based on their HPV ctDNA levels. The main goal is to see how long people live without their cancer progressing, measured at 2 years. To join, you must be at least 18 years old, have HPV-16 squamous cell carcinoma of the oropharynx, and have detectable HPV ctDNA before surgery.

Study design
This is an interventional study with a planned enrollment of 30 participants. It is structured into two groups (Arm A and Arm B) to test different approaches to radiation therapy based on HPV ctDNA levels.
What's involved
Participants will undergo HPV ctDNA evaluations using the NavDx assay, MRI studies, and complete questionnaires like EORTC QLQ H&N 35 and C30, MDADI-HN, and COST-FACIT.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint, pathologically confirmed progression-free survival, will be measured at 2 years.

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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)

Recruiting
PHASE2Ages 18+InterventionalDiagnostic
Memorial Sloan Kettering Cancer Center
~30 participants
Updated 2026-04-13 on ClinicalTrials.gov
What's tested:HPV ctDNA AssayMRI StudiesEORTC QLQ H&N 35 and C30MDADI-HNCOST-FACITIntensity-Modulated Radiation Therapy (Arm A)

At a glance

Recruiting sites
8 of 8 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Pathologically confirmed progression free survival
Measured over 2 years

Conditions

HPV
Oropharynx Cancer
HPV-Related Carcinoma
HPV-Related Malignancy
HPV Positive Oropharyngeal Squamous Cell Carcinoma

Explore related trials

Oropharyngeal CarcinomaHPV-16Human Papillomavirus DNA

Where it's being run

8 sites across 3 states
New York4
New Jersey3
Florida1

Study leadership

  • Acharf Shamseddine, MD · PRINCIPAL_INVESTIGATOR · Memorial Sloan Kettering Cancer Center

Who to contact

Acharf Shamseddine, MD
[email protected]
631-623-4272
Email the study team

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Eligibility criteria

Inclusion

Age ≥ 18
ECOG 0-2
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.
HPV ctDNA detectable by HPV digital PCR (Naveris assay) with a minimum of 50 copies/mL pre-operatively.
Surgical resection of all gross disease with no gross disease visualized on post-operative imaging.
Two, undetectable (\<1 copy/mL) post-operative HPV ctDNA within 2-6 weeks following surgery (blood drawn at least one week apart preferred).
A minimum of one of the following pathologic criteria: (Arm A)
AJCC 7 Stage: pT0N1-N2b, pT1N1, pT2N1, or ≥pT3
AJCC 7 ≥pN2
Lymphovascular invasion
Perineural invasion
Close pathologic margin (≤ 3 mm)
Signed informed consent form by the participant or their legally authorized representative (LAR).
A minimum of one of the following pathologic criteria (Arm B):
Microscopic positive margin
Extracapsular extension
Signed informed consent form by the participant or their legally authorized representative (LAR).
Adequate hematologic function within 30 days prior to registration, defined as follows:
White Blood Count (WBC) ≥ 2 K/mcL
Absolute neutrophil count (ANC) ≥ 1,000 cells/mm3
Platelets ≥ 100,000 cells/mm3
Hemoglobin ≥ 8.0 g/dl; Note: The use of transfusion or other intervention to achieve Hgb ≥ 8.0 g/dl is acceptable
Adequate renal function within 30 days prior to registration, defined as follows:
Serum creatinine \< 1.5 mg/dl or creatinine clearance (CC) ≥ 50 ml/min determined by 24-hour collection or estimated by Cockcroft-Gault formula:
CCr male = \[(140 - age) x (wt in kg)\] divided by \[(Serum Cr mg/dl) x (72)\]
CCr female = 0.85 x (CrCl male)
Adequate hepatic function within 30 days prior to registration, defined as follows:
Negative serum pregnancy test within 14 days prior to registration for women of childbearing potential

Exclusion

Metastatic disease
Non-HPV16 genotype (i.e. HPV-18,-31, -33, -35)
Patients who receive surgery at outside institution. Exceptions can be made for high-volume surgical centers at the discretion of the PI/co-PI
Prior head and neck radiation
Patients without pre-operative HPV ctDNA or pre-operative HPV ctDNA ≤ 50 copies/mL
Subjects with simultaneous primary cancers outside of the oropharynx
Prior invasive malignancy (except non-melanomatous skin cancer) unless disease free for 3 years or if cure rate from treatment at 5 years is 90% or greater
Prior systemic chemotherapy for the study cancer
Severe, active co-morbidity defined as follows:
Unstable angina and/or congestive heart failure requiring hospitalization within the last 6 months
Transmural myocardial infarction within the last 6 months
Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration
Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization within 30 days of registration
Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects
Lack of ability to understand and willingness to sign a written informed consent and complete questionnaires.

What this trial measures

  • Pathologically confirmed progression free survival2 years

    To estimate pathologically confirmed progression free survival (pPFS) two years post-operatively in HPV associated OPC patients who undergo active surveillance.