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Shortened Course of Radiation Therapy After Trans-oral Robotic Surgery in Patients With HPV-Mediated Oropharyngeal Squamous Cell Carcinoma. | Clinical Trials | Clareo Health

RECRUITINGPHASE2

Shortened Course of Radiation Therapy After Trans-oral Robotic Surgery in Patients With HPV-Mediated Oropharyngeal Squamous Cell Carcinoma.

Radiation Therapy in Reduced Dose and Hypofractionated Schedule After Trans-Oral Robotic Surgery in Intermediate Risk HPV-Mediated Oropharyngeal Squamous Cell Carcinoma

NCT07044635•University of Utah

View on ClinicalTrials.gov

Summary

The goal of this study is to evaluate if a shorter course of therapy can improve the quality of life in patients receiving radiation therapy after trans-oral robotic surgery.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Step 1 Registration: Pre-Operative Eligibility
•Participant aged ≥ 18 years.
•Diagnosis of oropharyngeal squamous cell carcinoma.
•Eligible to receive transoral robotic surgery.
•If status is known, p16 positivity or HPV positivity by in situ hybridization on pathological sampling of lymph node or primary oropharyngeal tumor. If status not known at the time of step-1 registration, otherwise eligible participants may be enrolled and HPV/p16 status must be determined prior to step-2 registration.
•Pre-operative TTMV-HPV DNA test collected or is planned to be collected. Pre-operative TTMV-HPV DNA may be collected anytime up until the day of surgery as long as it is prior to surgery.
•* Standard of care tests completed within 60 days of registration may be used for screening.
•* Tests results are not required to confirm eligibility for step 1 registration.
•ECOG Performance Status ≤ 2
•Able to provide informed consent and willing to sign an approved consent form that conforms to federal and institutional guidelines.
+29 more criteria

Exclusion Criteria

•History of prior mucosal head and neck cancer treated with radiation therapy
•Prior or concurrent malignancy whose natural history or treatment has the potential to interfere with the safety or efficacy assessment of this study
•Participant has smoked cigarettes within 1 month of registration
•Prior systemic anti-cancer therapy or any investigational therapy ≤ 14 days or within five half-lives prior to starting study treatment, whichever is shorter.
•Known distant metastatic disease.
•Current evidence of any condition that would, in the Investigator's judgment, contraindicate the participant's participation in the clinical study due to safety concerns or compliance with clinical study procedures (e.g., infection/inflammation, intestinal obstruction, unable to swallow medication, \[participants may not receive the drug through a feeding tube\], social/ psychological issues, etc.)
•Medical, psychiatric, cognitive, or other conditions that may compromise the participant's ability to understand the participant information, give informed consent, comply with the study protocol or complete the study.
•Step 2 Registration - Experimental Arm
•Meets ALL of the following criteria for low-risk disease (Note: participants may meet some without being excluded):
•* Pre-operative TTMV-HPV DNA positive
+13 more criteria

Locations (1)

Huntsman Cancer Institute/University of Utah

Salt Lake City, Utah, United States

Key Dates

Start Date

July 23, 2025

Primary Completion Date

August 1, 2029

Completion Date

August 1, 2030

Last Updated

February 27, 2026

Enrollment

ESTIMATED participants

Conditions

Oropharyngeal Squamous Cell CarcinomaHPV-mediated Oropharyngeal Squamous Cell Carcinoma

Interventions

Radiation Therapy

RADIATION

Contacts

Rachel Kingford

CONTACT

8015850115 rachel.kingsford@hci.utah.edu

Shane Lloyd

CONTACT

801-585-0255 shane.lloyd@hci.utah.edu

Testing Whether Cemiplimab (REGN2810) Plus CDX-1140 Given Prior to Surgery Are Better Than Cemiplimab (REGN2810) Alone in Patients With Stage III-IV Head and Neck Cancer

NCT06980038

Head and Neck Squamous Cell CarcinomaHypopharyngeal Squamous Cell Carcinoma+20 more

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RECRUITINGPHASE2

Radiation Therapy With or Without Cisplatin in Treating Patients With Stage III-IVA Squamous Cell Carcinoma of the Head and Neck Who Have Undergone Surgery

NCT02734537

Head and Neck Squamous Cell CarcinomaHypopharyngeal Squamous Cell Carcinoma+14 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 27, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Shortened Course of Radiation Therapy After Trans-oral Robotic Surgery in Patients With HPV-Mediated Oropharyngeal Squamous Cell Carcinoma.

Inclusion Criteria

Exclusion Criteria

Testing Whether Cemiplimab (REGN2810) Plus CDX-1140 Given Prior to Surgery Are Better Than Cemiplimab (REGN2810) Alone in Patients With Stage III-IV Head and Neck Cancer

Radiation Therapy With or Without Cisplatin in Treating Patients With Stage III-IVA Squamous Cell Carcinoma of the Head and Neck Who Have Undergone Surgery

E7 T-cell Receptor (TCR) -T Cell Induction Therapy for Locoregionally Advanced HPV-associated Cancers

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