protocolSection identificationModule nctId: NCT06373380, orgStudyIdInfo id: 23-293, briefTitle: A Study of HB-202/HB-201 in People With Human Papilloma Virus 16-Positive Head and Neck Squamous Cell Cancer (HPV 16+ HNSCC), statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04-15, primaryCompletionDateStruct date: 2027-04, completionDateStruct date: 2027-04, studyFirstPostDateStruct date: 2024-04-18, lastUpdatePostDateStruct date: 2024-04-18, sponsorCollaboratorsModule leadSponsor name: Memorial Sloan Kettering Cancer Center, class: OTHER, collaborators name: Hookipa Biotech GmbH, collaborators name: Naveris, descriptionModule briefSummary: The researchers are doing this study to find out if HB-202/HB-201 is an effective treatment for people with HPV 16-positive head and neck squamous cell cancer (HPV 16+ HNSCC) who have received standard treatment for their disease but then tested positive for HPV 16-related tumor DNA in the blood through a test called NavDx. Participants will have no evidence of cancer on imaging scans (radiographically) or by medical examination (clinically). Past studies have shown that a positive NavDx test strongly suggests the possible presence of microscopic cancer, though we do not know if testing positive will definitely lead to the cancer coming back (recurrence). The NavDx blood test has not been approved by the FDA and is considered investigational., conditionsModule conditions: HPV16+ Squamous Cell Carcinoma, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: This will be a randomized multi-centered, double-blind, placebo-controlled trial, primaryPurpose: TREATMENT, maskingInfo masking: TRIPLE, maskingDescription: The study will be conducted using a double-blind design., whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 51, type: ESTIMATED, armsInterventionsModule interventions name: HB-200, interventions name: Placebo, outcomesModule primaryOutcomes measure: Disease free survival (DFS), secondaryOutcomes measure: Number of participants with adverse events (type, frequency, severity)., eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Memorial Sloan Kettering at Basking Ridge (Limited Protocol Activities), status: RECRUITING, city: Basking Ridge, state: New Jersey, zip: 07920, country: United States, contacts name: Winston Wong, MD, role: CONTACT, phone: 646-608-4245, geoPoint lat: 40.70621, lon: -74.54932, locations facility: Memorial Sloan Kettering Monmouth (Limited Protocol Activities), status: RECRUITING, city: Middletown, state: New Jersey, zip: 07748, country: United States, contacts name: Winston Wong, MD, role: CONTACT, phone: 646-608-4245, geoPoint lat: 40.39652, lon: -74.09211, locations facility: Memorial Sloan Kettering Bergen (Limited Protocol Activities), status: RECRUITING, city: Montvale, state: New Jersey, zip: 07645, country: United States, contacts name: Winston Wong, MD, role: CONTACT, phone: 646-608-4245, geoPoint lat: 41.04676, lon: -74.02292, locations facility: Memorial Sloan Kettering Suffolk- Commack (Limited Protocol Activities), status: RECRUITING, city: Commack, state: New York, zip: 11725, country: United States, contacts name: Winston Wong, MD, role: CONTACT, phone: 646-608-4245, geoPoint lat: 40.84288, lon: -73.29289, locations facility: Memorial Sloan Kettering Westchester (Limited Protocol Activities), status: RECRUITING, city: Harrison, state: New York, zip: 10604, country: United States, contacts name: Winston Wong, MD, role: CONTACT, phone: 646-608-4245, geoPoint lat: 40.96899, lon: -73.71263, locations facility: Memorial Sloan Kettering Cancer Center (All Protocol Activites), status: RECRUITING, city: New York, state: New York, zip: 10065, country: United States, contacts name: Winston Wong, MD, role: CONTACT, phone: 646-608-4245, geoPoint lat: 40.71427, lon: -74.00597, locations facility: Memorial Sloan Kettering Nassau (Limited Protocol Activities), status: RECRUITING, city: Uniondale, state: New York, zip: 11553, country: United States, contacts name: Winston Wong, MD, role: CONTACT, phone: 646-608-4245, geoPoint lat: 40.70038, lon: -73.59291, hasResults: False