nctId: NCT06366451 id: MST01-AZN-05 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 overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2024-12 date: 2025-03 date: 2024-04-16 date: 2024-04-16 name: Presage Biosciences class: INDUSTRY name: AstraZeneca 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. conditions: Head and Neck Squamous Cell Carcinoma studyType: INTERVENTIONAL phases: EARLY_PHASE1 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 masking: NONE count: 15 type: ESTIMATED name: Rilvegostomig name: Volrustomig name: Sabestomig name: Pembrolizumab measure: Evaluation of signature scores using Gene Set Variability Analysis within regions injected with microdoses of rilvegostomig, volrustomig, sabestomig, or pembrolizumab measure: Incidence of reported Adverse Events and/or Adverse Device Effects [Safety and Tolerability] sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: UC Davis city: Sacramento state: California zip: 95817 country: United States name: Clinical Research Supervisor role: CONTACT name: Arnaud Bewley, MD role: PRINCIPAL_INVESTIGATOR lat: 38.58157 lon: -121.4944 facility: LSU Health Sciences Center - Shreveport city: Shreveport state: Louisiana zip: 71115 country: United States name: Research Coordinator role: CONTACT lat: 32.52515 lon: -93.75018 facility: Montefiore Medical Center city: Bronx state: New York zip: 10467 country: United States name: Research Coordinator role: CONTACT lat: 40.84985 lon: -73.86641 facility: University of North Carolina city: Chapel Hill state: North Carolina zip: 27599 country: United States name: Research Coordinator role: CONTACT lat: 35.9132 lon: -79.05584 facility: Oregon Health & Science University (OHSU) city: Portland state: Oregon zip: 97239 country: United States name: Research Coordinator role: CONTACT lat: 45.52345 lon: -122.67621 facility: University of Pennsylvania city: Philadelphia state: Pennsylvania zip: 19107 country: United States name: Research Coordinator role: CONTACT lat: 39.95233 lon: -75.16379 facility: Sarah Cannon Medical Center city: Charleston state: South Carolina zip: 29406 country: United States name: Research Coordinator role: CONTACT lat: 32.77657 lon: -79.93092 hasResults: False