nctId: NCT06373380 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) overallStatus: RECRUITING date: 2024-04-15 date: 2027-04 date: 2027-04 date: 2024-04-18 date: 2024-04-18 name: Memorial Sloan Kettering Cancer Center class: OTHER name: Hookipa Biotech GmbH name: Naveris 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. conditions: HPV16+ Squamous Cell Carcinoma studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: This will be a randomized multi-centered, double-blind, placebo-controlled trial primaryPurpose: TREATMENT masking: TRIPLE maskingDescription: The study will be conducted using a double-blind design. whoMasked: PARTICIPANT whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 51 type: ESTIMATED name: HB-200 name: Placebo measure: Disease free survival (DFS) measure: Number of participants with adverse events (type, frequency, severity). sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Memorial Sloan Kettering at Basking Ridge (Limited Protocol Activities) status: RECRUITING city: Basking Ridge state: New Jersey zip: 07920 country: United States name: Winston Wong, MD role: CONTACT phone: 646-608-4245 lat: 40.70621 lon: -74.54932 facility: Memorial Sloan Kettering Monmouth (Limited Protocol Activities) status: RECRUITING city: Middletown state: New Jersey zip: 07748 country: United States name: Winston Wong, MD role: CONTACT phone: 646-608-4245 lat: 40.39652 lon: -74.09211 facility: Memorial Sloan Kettering Bergen (Limited Protocol Activities) status: RECRUITING city: Montvale state: New Jersey zip: 07645 country: United States name: Winston Wong, MD role: CONTACT phone: 646-608-4245 lat: 41.04676 lon: -74.02292 facility: Memorial Sloan Kettering Suffolk- Commack (Limited Protocol Activities) status: RECRUITING city: Commack state: New York zip: 11725 country: United States name: Winston Wong, MD role: CONTACT phone: 646-608-4245 lat: 40.84288 lon: -73.29289 facility: Memorial Sloan Kettering Westchester (Limited Protocol Activities) status: RECRUITING city: Harrison state: New York zip: 10604 country: United States name: Winston Wong, MD role: CONTACT phone: 646-608-4245 lat: 40.96899 lon: -73.71263 facility: Memorial Sloan Kettering Cancer Center (All Protocol Activites) status: RECRUITING city: New York state: New York zip: 10065 country: United States name: Winston Wong, MD role: CONTACT phone: 646-608-4245 lat: 40.71427 lon: -74.00597 facility: Memorial Sloan Kettering Nassau (Limited Protocol Activities) status: RECRUITING city: Uniondale state: New York zip: 11553 country: United States name: Winston Wong, MD role: CONTACT phone: 646-608-4245 lat: 40.70038 lon: -73.59291 hasResults: False