Proton Spatially Fractionated Radiotherapy or Photon Stereotactic Body Radiotherapy in Combination With Pembrolizumab Before Surgery for the Treatment of Locally Advanced and Radiation-Naive Locoregionally Recurrent Oral Cavity Cancer, OSPRI Trial

Part of paid clinical trials in Rochester, Minnesota.

Sponsor
Mayo Clinic
Study ID
NCT07783581
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

  • Locally Advanced Oral Cavity Squamous Cell Carcinoma
  • Locally Recurrent Oral Cavity Squamous Cell Carcinoma
  • Oral Cavity Squamous Cell Carcinoma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Biopsy Procedure — PROCEDURE
    Undergo tissue biopsy
  • Biospecimen Collection — PROCEDURE
    Undergo blood sample collection
  • Computed Tomography — PROCEDURE
    Undergo CT or PET/CT
  • Magnetic Resonance Imaging — PROCEDURE
    Undergo PET/MRI
  • Pembrolizumab — BIOLOGICAL
    Given IV
  • Photon Stereotactic Body Radiation Therapy — RADIATION
    Receive photon SBRT
  • Positron Emission Tomography — PROCEDURE
    Undergo PET/CT or PET/MRI
  • Spatially-fractionated Radiation Therapy — RADIATION
    Receive proton SFRT
  • Surgical Procedure — PROCEDURE
    Undergo surgical resection

Study Details

This phase II trial compares the effect of adding proton spatially fractionated radiotherapy (SFRT) or photon stereotactic body radiotherapy (SBRT) to standard immunotherapy pembrolizumab before surgery (neoadjuvant) in treating patients with oral cavity squamous cell cancer that has spread to nearby tissue or lymph nodes (locally advanced) or that has come back where it first started (primary site) or near it (locoregionally recurrent) and have not had (naive) prior radiation. Radiation therapy uses high energy x-rays, particles, or radioactive seeds to kill tumor cells and shrink tumors. Proton SFRT is a type of external beam radiation treatment that uses streams of protons (tiny particles with a positive charge) to deliver different doses of radiation to different parts of the tumor in a grid like pattern. This type of radiation kills tumor cells but does not damage nearby tissues. SBRT is a type of external radiation therapy that uses special equipment to position a patient and precisely deliver radiation to tumors in the body (except the brain). The total dose of radiation is divided into smaller doses given over several days. This type of radiation therapy helps spare normal tissue. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the tumor, and may interfere with the ability of tumor cells to grow and spread. Giving neoadjuvant proton SFRT or SBRT in combination with pembrolizumab may be safe and tolerable and may be an effective approach to shrink the tumor, reduce the extent of surgery and/or the need for further treatment in patients with locally advanced or locoregionally recurrent oral cavity squamous cell cancer.

Key Dates

First listed
Aug 25, 2026
Start date
Sep 7, 2026
Status verified
Aug 2026
Primary completion
Apr 1, 2030
Completion
Apr 1, 2030

Study Design

Enrollment
30 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Arm A (proton SFRT, pembrolizumab, surgery)
    Patients receive proton SFRT QOD for up to 3 treatment fractions over 1 week. Starting within 7 days of initiating SFRT, patients receive pembrolizumab IV on day 1 of each cycle. Cycles repeat every 3 weeks for up to 2 cycles in the absence of disease progression or unacceptable toxicity. Within 8 weeks of completing pembrolizumab, patients undergo surgical resection per standard of care. Patients also undergo blood sample collection, CT, and PET/MRI or PET/CT throughout the study. Additionally, patients may also undergo tissue biopsy at baseline and/or on study.
  • Experimental: Arm B (photon SBRT, pembrolizumab, surgery)
    Patients receive photon SBRT QOD for up to 3 treatment fractions over 1 week. Starting within 7 days of initiating SBRT, patients receive pembrolizumab IV on day 1 of each cycle. Cycles repeat every 3 weeks for up to 2 cycles in the absence of disease progression or unacceptable toxicity. Within 8 weeks of completing pembrolizumab, patients undergo surgical resection per standard of care. Patients also undergo blood sample collection, CT, and PET/MRI or PET/CT throughout the study. Additionally, patients may also undergo tissue biopsy at baseline and/or on study.

Primary Outcome Measure

Improvement in major pathologic response rate (MPR) [ Time Frame: At the time of surgical resection ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Mayo Clinic in RochesterRochesterMinnesota55905
Clinical Trials Referral Office
[email protected]
855-776-0015
Daniel K. Ebner, MD, MPH (PRINCIPAL_INVESTIGATOR)

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