Squamous Cell Carcinoma of OropharynxNCT06915038

ctHPVDNA in HPV Positive Squamous Cell Carcinoma of the Oropharynx

A study testing NavDx, Adjuvant Radiation 30 Gray and Adjuvant Radiation 40 Gray in people with Squamous Cell Carcinoma of Oropharynx and HPV Positive Cancer, run by Indiana University at 2 sites in United States.

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Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts

Official record

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Trial summary

This study is a prospective phase II trial, designed to assess the efficacy and feasibility of adjuvant treatment deintensification guided by ctHPVDNA levels for patients with HPV+OPSCC who undergo transoral surgery and neck dissection. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Squamous Cell Carcinoma of Oropharynx, HPV Positive Cancer, Throat Cancer
What is being tested?: NavDx, Adjuvant Radiation 30 Gray and Adjuvant Radiation 40 Gray
Type of treatment: Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 120 participants
Where: 2 sitesUnited States
Study dates: 11 Jun 2025to Dec 2028
Phase: Interventional

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Pre-Surgery
Subjects ≥ 18 years old at the time of informed consent.
Ability to provide written informed consent and HIPAA authorization.
Eastern Cooperative Oncology Group (ECOG) performance status 0-2.
Primary tumor of the oropharynx (palatine tonsil, tongue base, soft palate, lateral or posterior walls of oropharynx).
Histopathologically confirmed squamous cell carcinoma.

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Detectable ctHPVDNA from blood samples collected prior to treatment.
Resectable and accessible tumor with high probability of achieving negative margins.
Smokers and non-smokers included.
Tumor stage (AJCC 8th edition): T1 or T2, and select T3 tumors that are mobile and do not invade the larynx.
Nodal stage (AJCC 8th edition): N0, N1 or N2.
HPV+ tumor, as determined by p16, in-situ hybridization, real-time polymerase chain reaction, or ctHPVDNA.
Post-Surgery
Subjects with unknown primaries included if primary is definitively identified and resectable with negative margins or if the palatine and lingual tonsils are thoroughly resected and pathologically proven to be negative for a primary.

Who cannot join

Serious medical condition preventing general anesthesia for surgery.
History of previous head and neck radiation or previous head and neck cancer within 3 years.
Distant metastatic disease present.
Subjects with synchronous HPV+ oropharynx primaries
Prior invasive malignant disease within 3 years, with the exception of non-melanoma skin cancer and thyroid cancer, unless patient is deemed cured or disease free, in which case patient may be included in the study.
Lactating or pregnant women. Women of childbearing potential must have a negative pregnancy test on the day of surgery. Women are considered to have childbearing potential (regardless of sexual orientation, having undergone a tubal ligation, or remaining celibate by choice) unless they meet one of the following criteria:
Has undergone a hysterectomy or bilateral oophorectomy; or
Has been naturally amenorrheic for at least 12 consecutive months.

Trial locations and contacts

2 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Azeezat Yekinni contact

317-529-6883

ayekinn@iu.edu

United States2 sites, 2 recruiting

IU Health Joe and Shelly Schwarz Cancer Center
Carmel, Indiana, 46032
Sarah Dutkevitch, RN, 317-278-5618, sdutkevi@iu.edu
Michael Sim, MD
Recruiting
Indiana University Melvin and Bren Simon Comprehensive Cancer Center
Indianapolis, Indiana, 46202
Azeezat Yekinni, 317-529-6883, ayekinn@iu.edu
Michael Sim, MD
Recruiting

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About this study

Official title: Circulating Tumor HPV DNA Driven Adjuvant Treatment Deintensification After Transoral Surgery for HPV-Positive Squamous Cell Carcinoma of the Oropharynx

Read the detailed description

Oropharyngeal squamous cell carcinoma (OPSCC), commonly known as throat cancer or tonsil cancer, has seen a dramatic rise in incidence over the last twenty years due to the increased incidence of human papillomavirus-positive (HPV) infection and * malignancy within the oropharynx.

The prevailing treatment philosophy within head and neck oncology is that deintensifying treatment could still provide equivalent oncologic outcomes, while further lowering toxicity profiles and improving functional outcomes to minimize the morbidity incurred by patients.

The next frontier in the treatment of HPV+ OPSCC, then, is the potential use of ctHPVDNA in the treatment personalization. Patients could be stratified into risk categories based on their ctHPVDNA levels, and in turn, receive a tailored treatment intensity accordingly.

The goal of this research study is to see if de-intensifying (stopping or scaling back) treatment still provides the same, or perhaps even better, results when compared to standard treatment when using your ctHPVDNA test results as a guide for your treatment.

Conditions: Squamous Cell Carcinoma of Oropharynx, HPV Positive Cancer, Throat Cancer, Tonsil Cancer
Being tested: NavDx, Adjuvant Radiation 30 Gray, Adjuvant Radiation 40 Gray
Keywords: NavDX, HPVctDNA, HPV, transoral surgery
Medical subject headings: Squamous Cell Carcinoma of Head and Neck, Tonsillar Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

NavDxDiagnostic test
NavDx is a clinically validated blood test to detect circulating tumor HPV DNA (ctHPVDNA). In this study, ctHPVDNA results, in conjuction with specimen analysis, will be used to assign post-surgical adjuvant treatment.
Adjuvant Radiation 30 GrayRadiation
If undetectable postoperative ctHPVDNA levels and five or more positive nodes, or confirmed extranodal extension (ENE) (greater than 2 mm) deintensified radiation treatment of 30 gray.
Adjuvant Radiation 40 GrayRadiation
If detectable postoperative ctHPVDNA, then reimage to evaluate for potentially operable disease, followed by appropriate surgery as indicated. If surgery is performed, repeat ctHPVDNA levels will be checked, and if then negative, subject will be placed in observation if N0 or N1 disease, and 30 Gy of radiation if N2 disease on final pathologic staging. If repeat ctHPVDNA level is positive, or shows no obvious operable disease, then subject will undergo 40 Gy of radiation.

Study groups in NCT06915038
Study group	Role	What they receive
Observation	Experimental	Subjects with undetectable postoperative ctHPVDNA levels and either 4 or fewer nodes will have no further adjuvant treatment. Receives: Diagnostic Test: NavDx
Adjuvant Radiation 30 Gray	Experimental	Subjects with undetectable postoperative ctHPVDNA levels after surgery, negative margins, and five or more positive nodes; or confirmed extranodal extension (ENE) (greater than 2 mm) will undergo deintensified radiation treatment of 30 gray. Receives: Diagnostic Test: NavDx; Radiation: Adjuvant Radiation 30 Gray
Adjuvant Radiation 40 Gray	Experimental	Subjects with positive postoperative ctHPVDNA will undergo reimaging to evaluate for potentially operable disease, followed by appropriate surgery as indicated. If surgery is performed, repeat ctHPVDNA levels will be checked, and if then negative, subject will be placed in observation or 30 Gy of radiation depending on nodal status. If repeat ctHPVDNA level is positive, or subject has no obvious operable disease then subject will undergo 40 Gy of radiation. Receives: Diagnostic Test: NavDx; Radiation: Adjuvant Radiation 40 Gray

What is being measured

The primary outcome is the main question the study is designed to answer.

Disease Free Survival
Time from surgery to first disease recurrence or death from any cause
Measured: Up to 24 months post initial surgery

Secondary outcomes (6)

Local-reginal Control
Number of subjects with no recurrence at primary oropharyngeal site or in the neck nodal basins
Measured: Up to 24 months post initial surgery
Overall Survival
Time from surgery to death from any cause
Measured: Up to 24 months post initial surgery
Distant metastasis rates
Assessed by tissue diagnosis or radiographically of recurrent disease at sites away from the primary tumor and neck nodal basins
Measured: Up to 24 months post initial surgery
Adverse Events
Number of subjects that experience adverse events, grades 1-5, as assessed by the National Cancer Institute Common Toxicity Criteria (NCI-CTCAE) version 5.0
Measured: up to 6 months post initial surgery
Swallowing-related Quality Of Life
Assessed using MD Anderson Dysphagia Inventory (MDADI)
Measured: 3 months, 6 months, 12 months, and 24 months post initial surgery
Gastrostomy tube dependence rates
Assessed by confirmation of feeding tube in-situ in subject and being utilized for nutrition
Measured: 12 and 24 months post intial surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

11 Jun 2025Dec 2028

First posted7 Apr 2025
Study start11 Jun 2025
Primary completionDec 2028 (estimated)
Study completionDec 2028 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Squamous Cell Carcinoma of OropharynxStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Sequential
Masking: None (open label)
Enrolment: 120 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06915038
Sponsor's protocol ID: CTO-IUSCCC-0895
Status last verified: Aug 2026
First submitted: 1 Apr 2025
Last updated: 11 Aug 2026
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: Yes

Interested in taking part?

Azeezat Yekinni

317-529-6883

ayekinn@iu.edu

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See sites and contacts

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Phase II Trial of Neoadjuvant Chemotherapy (NAC) Alone or in Combination With Immunotherapy Vaccine PRGN-2009 in Subjects With Newly Diagnosed HPV-Associated Oropharyngeal (Head and Neck) Cancer
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E7 T-cell Receptor (TCR) -T Cell Induction Therapy for Locoregionally Advanced HPV-associated Cancers
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Scheduled IV Fluids in the Supportive Management of Patients Undergoing Chemo-radiotherapy for Head and Neck Cancer
Squamous Cell Carcinoma of Hypopharynx, Squamous Cell Carcinoma of Larynx
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Selective Avoidance of Nodal VolumEs at Minimal Risk (GCC 20110)
Head and Neck Cancer, Oropharynx Cancer
RecruitingObservational study
Immune Biomarker Study for Cisplatin-ineligible Patients Receiving Chemoradiotherapy With Docetaxel
Squamous Cell Carcinoma of Oropharynx, Squamous Cell Carcinoma of the Hypopharynx

All Squamous Cell Carcinoma of Oropharynx trials