Proton or Photon Radiotherapy Added to Pembrolizumab Before Surgery for Advanced or Recurrent Oral Cavity Cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a phase II interventional study evaluating neoadjuvant pembrolizumab combined with either proton spatially fractionated radiotherapy or photon SBRT in patients with HPV/p16-unrelated oral cavity squamous cell carcinoma that is locally advanced or locoregionally recurrent and radiation-naïve. Participants will undergo imaging and biopsy procedures, receive the combination therapy, and proceed to surgical resection when feasible. The trial aims to see if this radiotherapy-immunotherapy strategy improves tumor response and potentially surgical outcomes, with correlative tissue and blood analyses. Eligible patients must be adults with adequate performance status and PD-L1 expression, and must be willing to return for follow-up and provide specimens. The lead sponsor is Mayo Clinic, with site(s) in Rochester, Minnesota.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Patients with histologically confirmed human papillomavirus (HPV)/p16-unrelated squamous cell carcinoma of the oral cavity and:

  * Either locally advanced (T3-T4) non-metastatic disease, or
  * Radiation-naïve locoregionally recurrent disease (prior radiation to a site outside of the treatment fields is permitted)
* Age ≥ 18 years old
* Eastern Cooperative Oncology Group (ECOG) performance status (PS) ≤ 2
* Eligible to receive immunotherapy on multidisciplinary evaluation
* Ability to complete questionnaire(s) by themselves or with assistance
* Provide signed written informed consent in accordance with ethical, regulatory, and institutional requirements
* Willing to return to enrolling institution for follow-up (during the active monitoring phase of the study)
* Willing to consent to and provide tissue and blood samples for correlative research purposes (not the optional Riskguard and OncoExtra testing)
* PD-L1 combined positive score ≥ 1

Exclusion Criteria:

* Participation in another clinical study with an investigational product during the last 3 months (12 weeks)

  * Exception: Unless it is an observational (non-interventional) clinical study during the follow-up period of the study
* Contraindications to pembrolizumab
* Prior radiation therapy to the head and neck
* Previous anticancer therapeutic received ≤ 30 days prior to registration, or adequate washout period on a per-agent basis, or concurrent anti-cancer therapeutic not specified by this protocol
* Uncontrolled pre-existing condition(s), such as infection, congestive heart failure, hypertension, angina, arrhythmia, chronic diarrhea, psychiatric conditions, or others, that in the opinion of the treating investigator limits the ability to provide consent or longitudinal participation in this study
* Inability to place 2 or more SFRT spheres within the tumor target
* Prophylactic placement of feeding tubes is not allowed

Where it's running

• Mayo Clinic in Rochester
  Rochester, Minnesota, United States Recruiting

Study contacts

• Principal investigator: Daniel K. Ebner, MD, MPH — Mayo Clinic in Rochester
• Study coordinator: Clinical Trials Referral Office
• Email: mayocliniccancerstudies@mayo.edu
• Phone: 855-776-0015

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.