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)
Studieoversigt
Status
Status
Betingelser
Betingelser
Intervention / Behandling
Intervention / Behandling
- Biologisk: Pembrolizumab
- Procedure: Bioprøvesamling
- Procedure: MR scanning
- Procedure: Kirurgisk procedure
- Procedure: Computertomografi
- Procedure: Positron emissionstomografi
- Procedure: Biopsi -procedure
- Stråling: Spatially-fractionated Radiation Therapy
- Stråling: Photon Stereotactic Body Radiation Therapy
Undersøgelsestype
Undersøgelsestype
Tilmelding (Anslået)
Tilmelding
Fase
Fase
- Fase 2
Kontakter og lokationer
Studiekontakt
Studiekontakt
- Navn: Clinical Trials Referral Office
- Telefonnummer: 855-776-0015
- E-mail: mayocliniccancerstudies@mayo.edu
Studiesteder
-
-
Minnesota
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Rochester, Minnesota, Forenede Stater, 55905
- Mayo Clinic in Rochester
-
Kontakt:
- Clinical Trials Referral Office
- Telefonnummer: 855-776-0015
- E-mail: mayocliniccancerstudies@mayo.edu
-
Ledende efterforsker:
- Daniel K. Ebner, MD, MPH
-
-
Deltagelseskriterier
Berettigelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Beskrivelse
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
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Antal våben
Våben og indgreb
Deltagergruppe / ArmDeltagergruppe / Arm |
Intervention / BehandlingIntervention / Behandling |
|---|---|
|
Eksperimentel: 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.
|
Givet IV
Andre navne:
Gennemgå blodprøvetagning
Andre navne:
Gennemgå PET/MRI
Andre navne:
Gennemgå kirurgisk resektion
Andre navne:
Gennemgå CT eller PET/CT
Andre navne:
Gennemgå PET/CT eller PET/MRI
Andre navne:
Gennemgå vævsbiopsi
Andre navne:
Receive proton SFRT
Andre navne:
|
|
Eksperimentel: 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.
|
Givet IV
Andre navne:
Gennemgå blodprøvetagning
Andre navne:
Gennemgå PET/MRI
Andre navne:
Gennemgå kirurgisk resektion
Andre navne:
Gennemgå CT eller PET/CT
Andre navne:
Gennemgå PET/CT eller PET/MRI
Andre navne:
Gennemgå vævsbiopsi
Andre navne:
Receive photon SBRT
Andre navne:
|
Hvad måler undersøgelsen?
Primære resultatmål
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Improvement in major pathologic response rate (MPR)
Tidsramme: At the time of surgical resection
|
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
|
Sekundære resultatmål
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Pathologic complete response rate
Tidsramme: At the time of surgical resection
|
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.
|
At the time of surgical resection
|
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Percent of patients receiving the prescribed therapy
Tidsramme: Up to 1 year
|
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
|
|
Incidence of Adverse Events (AEs) Prior to Surgery:
Tidsramme: From the time of registration until 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.
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From the time of registration until surgery
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Samarbejdspartnere og efterforskere
Sponsor
Sponsor
Efterforskere
Efterforskere
- Ledende efterforsker: Daniel K. Ebner, MD, MPH, Mayo Clinic in Rochester
Publikationer og nyttige links
Hjælpsomme links
Datoer for undersøgelser
Studer store datoer
Studiestart (Anslået)
Studiestart
Primær færdiggørelse (Anslået)
Primær færdiggørelse
Studieafslutning (Anslået)
Studieafslutning
Datoer for studieregistrering
Først indsendt
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Først opslået
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering sendt
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
- Neoplasmer efter sted
- Neoplasmer
- Neoplasmer efter histologisk type
- Neoplasmer i hoved og hals
- Neoplasmer, kirtel og epitel
- Karcinom
- Karcinom, pladecelle
- Planocellulært karcinom i hoved og hals
- Undersøgelsesteknikker
- Kliniske laboratorieteknikker
- Diagnostiske teknikker og procedurer
- Diagnose
- Cytologiske teknikker
- Cytodiagnose
- Diagnostiske teknikker, kirurgisk
- Kemiteknikker, analytisk
- Spektrumanalyse
- Biopsi
- Håndtering af eksemplar
- pembrolizumab
- Magnetisk resonansspektroskopi
- Kirurgiske procedurer, operative
Andre undersøgelses-id-numre
Andre undersøgelses-id-numre
- GMROR2472
- NCI-2026-05918 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
- 24-011038 (Anden identifikator: Mayo Clinic Institutional Review Board)
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
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