protocolSection identificationModule nctId: NCT06366451, orgStudyIdInfo id: MST01-AZN-05, secondaryIdInfos id: PBI-MST-01, type: OTHER, domain: Presage Biosciences, briefTitle: PBI-MST-01 (NCT04541108) Substudy AZN-05: Intratumoral Microdosing of Rilvegostomig, Volrustomig, and Sabestomig in HNSCC, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2024-12, completionDateStruct date: 2025-03, studyFirstPostDateStruct date: 2024-04-16, lastUpdatePostDateStruct date: 2024-04-16, sponsorCollaboratorsModule leadSponsor name: Presage Biosciences, class: INDUSTRY, collaborators name: AstraZeneca, descriptionModule briefSummary: This is a multi-center, open-label, Phase 0 substudy designed to evaluate the localized pharmacodynamics (PD) of rilvegostomig, volrustomig, and sabestomig within the tumor microenvironment (TME) when administered intratumorally in microdose quantities via the CIVO device in patients presenting with Head and Neck Squamous Cell Carcinoma (HNSCC) with a surface accessible lesion, who are scheduled for tumor and/or regional node dissection as part of their standard treatment. PD effects due to injected investigational agents will be compared to those elicited by pembrolizumab alone, which will also be injected in microdose quantities via the CIVO device., conditionsModule conditions: Head and Neck Squamous Cell Carcinoma, designModule studyType: INTERVENTIONAL, phases: EARLY_PHASE1, designInfo allocation: NA, interventionModel: SINGLE_GROUP, interventionModelDescription: This is an exploratory clinical trial to evaluate intratumoral mechanistic effects of novel and approved agents on intact human tumors. This is a cohort substudy of a Master Protocol (PBI-MST-01, NCT04541108) framework, under which comparisons will not be made between substudy cohorts., primaryPurpose: BASIC_SCIENCE, maskingInfo masking: NONE, enrollmentInfo count: 15, type: ESTIMATED, armsInterventionsModule interventions name: Rilvegostomig, interventions name: Volrustomig, interventions name: Sabestomig, interventions name: Pembrolizumab, outcomesModule primaryOutcomes measure: Evaluation of signature scores using Gene Set Variability Analysis within regions injected with microdoses of rilvegostomig, volrustomig, sabestomig, or pembrolizumab, secondaryOutcomes measure: Incidence of reported Adverse Events and/or Adverse Device Effects [Safety and Tolerability], eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: UC Davis, city: Sacramento, state: California, zip: 95817, country: United States, contacts name: Clinical Research Supervisor, role: CONTACT, contacts name: Arnaud Bewley, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 38.58157, lon: -121.4944, locations facility: LSU Health Sciences Center - Shreveport, city: Shreveport, state: Louisiana, zip: 71115, country: United States, contacts name: Research Coordinator, role: CONTACT, geoPoint lat: 32.52515, lon: -93.75018, locations facility: Montefiore Medical Center, city: Bronx, state: New York, zip: 10467, country: United States, contacts name: Research Coordinator, role: CONTACT, geoPoint lat: 40.84985, lon: -73.86641, locations facility: University of North Carolina, city: Chapel Hill, state: North Carolina, zip: 27599, country: United States, contacts name: Research Coordinator, role: CONTACT, geoPoint lat: 35.9132, lon: -79.05584, locations facility: Oregon Health & Science University (OHSU), city: Portland, state: Oregon, zip: 97239, country: United States, contacts name: Research Coordinator, role: CONTACT, geoPoint lat: 45.52345, lon: -122.67621, locations facility: University of Pennsylvania, city: Philadelphia, state: Pennsylvania, zip: 19107, country: United States, contacts name: Research Coordinator, role: CONTACT, geoPoint lat: 39.95233, lon: -75.16379, locations facility: Sarah Cannon Medical Center, city: Charleston, state: South Carolina, zip: 29406, country: United States, contacts name: Research Coordinator, role: CONTACT, geoPoint lat: 32.77657, lon: -79.93092, hasResults: False