[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100653387":3},{"organization":4,"outcomesModule":7,"designInfo":26,"detailedDescription":25,"studyPopulation":25,"armGroups":32,"interventions":51,"overallOfficials":177,"centralContacts":182,"locations":188,"responsibleParty":204,"collaborators":25,"id":206,"slug":207,"hasResults":208,"nctId":209,"briefTitle":210,"officialTitle":211,"acronym":25,"eligibilityCriteria":212,"healthyVolunteers":208,"sex":213,"minAge":214,"maxAge":25,"enrollmentInfo":215,"targetDuration":25,"studyType":218,"phases":219,"briefSummary":221,"conditions":222,"keywords":25,"overallStatus":226,"whyStopped":25,"lastUpdateSubmitDate":227,"lastUpdatePostDateStruct":228,"startDateStruct":231,"completionDateStruct":233,"leadSponsor":235,"locationsCount":236},{"fullName":5,"class":6},"Mayo Clinic","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":25},[9],{"measure":10,"description":11,"timeFrame":12},"Improvement in major pathologic response rate (MPR)","MPR is defined from pathologic evaluation of the surgically resected tumor, demonstrating less than 10% of residual tumor in the resection sample (≥90% disease reduction). Will be assessed using a Bayesian pick-the-winner randomized phase-II clinical trial design.","At the time of surgical resection",[14,17,21],{"measure":15,"description":16,"timeFrame":12},"Pathologic complete response rate","Pathologic complete response rate is defined from pathologic evaluation of the surgically resected tumor, demonstrating no signs of residual disease following immuno-radiation. This will be calculated separately for Arm A and for Arm B.",{"measure":18,"description":19,"timeFrame":20},"Percent of patients receiving the prescribed therapy","Will be defined as the number of patients who received the prescribed therapy divided by the number of evaluable patients who signed a consent form and began treatment. This will be calculated separately for Arm A and Arm B.","Up to 1 year",{"measure":22,"description":23,"timeFrame":24},"Incidence of Adverse Events (AEs) Prior to Surgery:","Overall AEs, overall toxicities, and by maximum grade per type of AE per patient of the AEs that occur before surgery will be explored and summarized descriptively, mainly through the use of frequency tables. Toxicity is defined as an adverse event that is classified as possibly, probably, or definitely related to study treatment. AEs are graded per National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 6.0.","From the time of registration until surgery",null,{"allocation":27,"interventionModel":28,"interventionModelDescription":25,"primaryPurpose":29,"observationalModel":25,"timePerspective":25,"maskingInfo":30},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":31,"maskingDescription":25,"whoMasked":25},"NONE",[33,46],{"label":34,"type":35,"description":36,"interventionNames":37},"Arm A (proton SFRT, pembrolizumab, surgery)","EXPERIMENTAL","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\u002FMRI or PET\u002FCT throughout the study. Additionally, patients may also undergo tissue biopsy at baseline and\u002For on study.",[38,39,40,41,42,43,44,45],"Procedure: Biopsy Procedure","Procedure: Biospecimen Collection","Procedure: Computed Tomography","Procedure: Magnetic Resonance Imaging","Biological: Pembrolizumab","Procedure: Positron Emission Tomography","Radiation: Spatially-fractionated Radiation Therapy","Procedure: Surgical Procedure",{"label":47,"type":35,"description":48,"interventionNames":49},"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\u002FMRI or PET\u002FCT throughout the study. Additionally, patients may also undergo tissue biopsy at baseline and\u002For on study.",[38,39,40,41,42,50,43,45],"Radiation: Photon Stereotactic Body Radiation Therapy",[52,61,70,87,107,136,143,155,163],{"type":53,"name":54,"description":55,"armGroupLabels":56,"otherNames":57},"PROCEDURE","Biopsy Procedure","Undergo tissue biopsy",[34,47],[58,59,60],"Biopsy","BIOPSY_TYPE","Bx",{"type":53,"name":62,"description":63,"armGroupLabels":64,"otherNames":65},"Biospecimen Collection","Undergo blood sample collection",[34,47],[66,67,68,69],"Biological Sample Collection","Biospecimen Collected","Sample Collection","Specimen Collection",{"type":53,"name":71,"description":72,"armGroupLabels":73,"otherNames":74},"Computed Tomography","Undergo CT or PET\u002FCT",[34,47],[75,76,77,78,79,80,81,82,83,84,85,86],"CAT","CAT Scan","Computed Axial Tomography","Computerized Axial Tomography","Computerized axial tomography (procedure)","Computerized Tomography","Computerized Tomography (CT) scan","CT","CT Scan","Diagnostic CAT Scan","Diagnostic CAT Scan Service Type","tomography",{"type":53,"name":88,"description":89,"armGroupLabels":90,"otherNames":91},"Magnetic Resonance Imaging","Undergo PET\u002FMRI",[34,47],[92,93,94,95,96,97,98,99,100,101,102,103,104,105,106],"Magnetic Resonance","Magnetic Resonance Imaging (MRI)","Magnetic resonance imaging (procedure)","Magnetic Resonance Imaging Scan","Medical Imaging, Magnetic Resonance \u002F Nuclear Magnetic Resonance","MR","MR Imaging","MRI","MRI Scan","MRIs","NMR Imaging","NMRI","Nuclear Magnetic Resonance Imaging","sMRI","Structural MRI",{"type":108,"name":109,"description":110,"armGroupLabels":111,"otherNames":112},"BIOLOGICAL","Pembrolizumab","Given IV",[34,47],[113,114,115,116,117,118,119,120,121,122,123,124,125,126,127,128,129,130,131,132,133,134,135],"BCD-201","GME 751","GME751","Keytruda","Lambrolizumab","MK 3475","MK-3475","MK3475","Pembrolizumab Biosimilar BCD-201","Pembrolizumab Biosimilar GME751","Pembrolizumab Biosimilar QL2107","Pembrolizumab Biosimilar RPH-075","Pembrolizumab Biosimilar SB27","QL2107","RPH 075","RPH-075","RPH075","SB 27","SB-27","SB27","SCH 900475","SCH-900475","SCH900475",{"type":137,"name":138,"description":139,"armGroupLabels":140,"otherNames":141},"RADIATION","Photon Stereotactic Body Radiation Therapy","Receive photon SBRT",[47],[142],"Photon SBRT",{"type":53,"name":144,"description":145,"armGroupLabels":146,"otherNames":147},"Positron Emission Tomography","Undergo PET\u002FCT or PET\u002FMRI",[34,47],[148,149,150,151,152,153,154],"Medical Imaging, Positron Emission Tomography","PET","PET Scan","Positron emission tomography (procedure)","Positron Emission Tomography Scan","Positron-Emission Tomography","PT",{"type":137,"name":156,"description":157,"armGroupLabels":158,"otherNames":159},"Spatially-fractionated Radiation Therapy","Receive proton SFRT",[34],[160,161,162],"GRID Therapy","SFRT","Spatially Fractionated Radiation Therapy",{"type":53,"name":164,"description":165,"armGroupLabels":166,"otherNames":167},"Surgical Procedure","Undergo surgical resection",[34,47],[168,169,170,171,172,173,174,175,176],"Operation","Surgery","Surgery Type","Surgery, NOS","Surgical","Surgical Intervention","Surgical Interventions","Surgical Procedures","Type of Surgery",[178],{"name":179,"affiliation":180,"role":181},"Daniel K. Ebner, MD, MPH","Mayo Clinic in Rochester","PRINCIPAL_INVESTIGATOR",[183],{"name":184,"role":185,"phone":186,"phoneExt":25,"email":187},"Clinical Trials Referral Office","CONTACT","855-776-0015","mayocliniccancerstudies@mayo.edu",[189],{"facility":180,"status":25,"city":190,"state":191,"zip":192,"country":193,"countryCode":194,"cosmosGeoPoint":195,"geoPoint":200,"contacts":201},"Rochester","Minnesota","55905","United States","US",{"type":196,"coordinates":197},"Point",[198,199],-92.4699,44.02163,{"lat":199,"lon":198},[202,203],{"name":184,"role":185,"phone":186,"phoneExt":25,"email":187},{"name":179,"role":181,"phone":25,"phoneExt":25,"email":25},{"type":205,"investigatorFullName":25,"investigatorTitle":25,"investigatorAffiliation":25,"oldNameTitle":25,"oldOrganization":25},"SPONSOR","100653387","phase-2-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-100653387",false,"NCT07783581","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","Phase II: Randomized Neoadjuvant Treatment of Oral Cavity Cancer With Spatially Fractionated Proton Radiotherapy and Immunotherapy (OSPRI)","Inclusion Criteria:\n\n* Patients with histologically confirmed human papillomavirus (HPV)\u002Fp16-unrelated squamous cell carcinoma of the oral cavity and:\n\n  * Either locally advanced (T3-T4) non-metastatic disease, or\n  * Radiation-naïve locoregionally recurrent disease (prior radiation to a site outside of the treatment fields is permitted)\n* Age ≥ 18 years old\n* Eastern Cooperative Oncology Group (ECOG) performance status (PS) ≤ 2\n* Eligible to receive immunotherapy on multidisciplinary evaluation\n* Ability to complete questionnaire(s) by themselves or with assistance\n* Provide signed written informed consent in accordance with ethical, regulatory, and institutional requirements\n* Willing to return to enrolling institution for follow-up (during the active monitoring phase of the study)\n* Willing to consent to and provide tissue and blood samples for correlative research purposes (not the optional Riskguard and OncoExtra testing)\n* PD-L1 combined positive score ≥ 1\n\nExclusion Criteria:\n\n* Participation in another clinical study with an investigational product during the last 3 months (12 weeks)\n\n  * Exception: Unless it is an observational (non-interventional) clinical study during the follow-up period of the study\n* Contraindications to pembrolizumab\n* Prior radiation therapy to the head and neck\n* 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\n* 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\n* Inability to place 2 or more SFRT spheres within the tumor target\n* Prophylactic placement of feeding tubes is not allowed","ALL","18 Years",{"count":216,"type":217},30,"ESTIMATED","INTERVENTIONAL",[220],"PHASE2","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\u002For the need for further treatment in patients with locally advanced or locoregionally recurrent oral cavity squamous cell cancer.",[223,224,225],"Locally Advanced Oral Cavity Squamous Cell Carcinoma","Locally Recurrent Oral Cavity Squamous Cell Carcinoma","Oral Cavity Squamous Cell Carcinoma","NOT_YET_RECRUITING","2026-08-20",{"date":229,"type":230},"2026-08-25","ACTUAL",{"date":232,"type":217},"2026-09-07",{"date":234,"type":217},"2030-04-01",{"name":5,"class":6},1]