ctHPVDNA in HPV Positive Squamous Cell Carcinoma of the Oropharynx

NCT06915038 | Recruiting DMC FDA Device

• 1 other identifier: CTO-IUSCCC-0895
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Squamous Cell Carcinoma of Oropharynx; HPV Positive Cancer; Throat Cancer; Tonsil Cancer

Keywords

NavDX; HPVctDNA; HPV; transoral surgery

Outcome Measures

Primary Outcomes (1)

• Disease Free Survival

  Time from surgery to first disease recurrence or death from any cause

  Up to 24 months post initial surgery

Secondary Outcomes (6)

• Local-reginal Control

  Up to 24 months post initial surgery

• Overall Survival

  Up to 24 months post initial surgery

• Distant metastasis rates

  Up to 24 months post initial surgery

• Adverse Events

  up to 6 months post initial surgery

• Swallowing-related Quality Of Life

  3 months, 6 months, 12 months, and 24 months post initial surgery

Study Arms (3)

Observation

EXPERIMENTAL

Subjects with undetectable postoperative ctHPVDNA levels and either 4 or fewer nodes will have no further adjuvant treatment.

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.

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.

Diagnostic Test: NavDx; Radiation: Adjuvant Radiation 40 Gray

Interventions

NavDx DIAGNOSTIC_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 Gray; Adjuvant Radiation 40 Gray; Observation

Adjuvant Radiation 30 Gray RADIATION

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 30 Gray

Adjuvant Radiation 40 Gray RADIATION

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.

Adjuvant Radiation 40 Gray

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.
• Mobile neck nodes on physical exam if N positive.
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Indiana University: lead

Study Sites (2)

IU Health Joe and Shelly Schwarz Cancer Center

Carmel, Indiana, 46032, United States

RECRUITING

Indiana University Melvin and Bren Simon Comprehensive Cancer Center

Indianapolis, Indiana, 46202, United States

RECRUITING

MeSH Terms

Conditions

Squamous Cell Carcinoma of Head and Neck; Tonsillar Neoplasms

Condition Hierarchy (Ancestors)

Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Head and Neck Neoplasms; Neoplasms by Site; Oropharyngeal Neoplasms; Pharyngeal Neoplasms; Otorhinolaryngologic Neoplasms; Pharyngeal Diseases; Stomatognathic Diseases; Otorhinolaryngologic Diseases

Study Officials

• Michael Sim, MD

  Indiana University Melvin and Bren Simon Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Azeezat Yekinni

CONTACT

317-529-6883; ayekinn@iu.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, Department of Otolaryngology-Head & Neck Surgery

Study Record Dates

• First Submitted: April 1, 2025
• First Posted: April 7, 2025
• Study Start: June 11, 2025
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): December 1, 2028
• Last Updated: July 31, 2025

Record last verified: 2025-07

Locations

US (2)