Phase 2: testing Pembrolizumab for Locally Advanced Oral Cavity Squamous Cell Carcinoma
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 (who have not tried this kind of treatment before) prior radiation. Radiation therapy uses high energy x-rays, particles, or radioactive seeds to kill tumor cells and shrink tumors.
Official registry: https://clinicaltrials.gov/study/NCT07783581 · Mayo Clinic · enrollment listed as 30
What this phase means
Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.
Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.
What the registry says happens
If you join, the listed intervention(s) are Biopsy Procedure, Biospecimen Collection, or Computed Tomography. The registry lists allocation as randomized. 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 (who have not tried this kind of treatment before) prior radiation.
They plan to enroll about 30 people at Rochester. Taking part typically means an infusion or injection of a biologic, a procedure as part of the study plus check-ins.
Official title (unrewritten)
Phase II: Randomized Neoadjuvant Treatment of Oral Cavity Cancer With Spatially Fractionated Proton Radiotherapy and Immunotherapy (OSPRI)
Interventions: Biopsy Procedure, Biospecimen Collection, Computed Tomography, Magnetic Resonance Imaging, Pembrolizumab, Photon Stereotactic Body Radiation Therapy, Positron Emission Tomography, Spatially-fractionated Radiation Therapy, Surgical Procedure
Primary outcome (registry wording): Improvement in major pathologic response rate (MPR)
Who it is for (from inclusion criteria)
- Ages 18 Years to any
- 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)
- 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
- Willing to return to enrolling institution for follow-up (during the active monitoring phase of the study)
Who the registry excludes
- Participation in another clinical study with an investigational product during the last 3 months (12 weeks)
- Exception: Unless it is an watch-and-measure (no experimental treatment required) (non-treatment) 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
- Inability to place 2 or more SFRT spheres within the tumor target
- Prophylactic placement of feeding tubes is not allowed
Public study contact (from the registry)
Clinical Trials Referral Office
mayocliniccancerstudies@mayo.edu
Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.
Sites listed on ClinicalTrials.gov
1 listed- Mayo Clinic in Rochester — Rochester, Minnesota (recruiting)
FAQ about this NCT record
Is NCT07783581 still recruiting?
The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.
What phase is NCT07783581?
Phase 2. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.
Can PlainTrials tell me if I qualify for NCT07783581?
No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.
How to read a ClinicalTrials.gov record · Questions to ask the coordinator · Glossary