{"preliminary_commentary":{"by_channel":{"youtube":2,"podcast":2,"x_thread":2},"note":"Preliminary. Indexed podcasts, YouTube videos and X posts that name this trial so far. This is where a report starts, not where it ends: the build searches for more, so finished reports usually cover more than this."},"free_build":{"available":false},"commentary_summary":null,"name":"TARGET-HPV","nct_id":"NCT05108870","offer":{"currency":"USD","how":"Order at https://www.erudio.com/contact?report=target-hpv-nct05108870. The price is an estimate of verified statements from the commentary indexed so far, fixed at order. Final coverage is set when the report is built. We build the report within 24 hours of confirming the order and deliver it when it passes our checks; if it cannot be built to our standard, nothing is charged.","price_usd":750,"size":"focused","size_rule":"Focused: 1–150 verified statements, estimated at 14 per indexed commentary source"},"registry":{"acronym":null,"arms":[{"description":"All participants in this group will receive HB-201 combined with chemotherapy using carboplatin and paclitaxel.\n\n\\- HB-201 will be administered on cycle 1 day 15, cycle 2 day 15, and cycle 3 day 15 with three 21-day cycles of carboplatin on day 1 and paclitaxel 100mg/m2 on days 1, 8, and 15","label":"Phase 1: Dose-Finding Group 1 - Drug Combination 1","type":"EXPERIMENTAL"},{"description":"All participants in this group will receive alternating doses of HB-201 and HB-202 combined with chemotherapy using carboplatin and paclitaxel.\n\nParticipants will be given 3 doses of HB-201 \\& HB-202 alternating two vector therapy. Patients will receive 2 doses of HB-202 and 1 dose of HB-201. HB-202 will be administered on cycle 1 day 15 and cycle 3 day 15, and HB-201 will be administered on cycle 2 day 15 with three 21-day cycles of chemotherapy with carboplatin on day 1 and paclitaxel 100mg/m2 on days 1, 8, and 15.","label":"Phase 1: Dose-Finding Group 2 - Drug Combination 2","type":"EXPERIMENTAL"},{"description":"Participants in this group will receive HB-201 combined with chemotherapy using carboplatin and paclitaxel at the dose established in the first phase of the study.\n\nAfter completing treatment at the established phase 2 dose, subjects will receive surgery, radiotherapy alone, or chemotherapy with radiotherapy together based on how their tumor responds to the medications.","label":"Phase 2: Efficacy Arm 1 - HB-201 + Chemotherapy","type":"EXPERIMENTAL"},{"description":"Participants in this group will receive alternating doses of HB-201 and HB-202 combined with chemotherapy using carboplatin and paclitaxel at the dose established in the first phase of the study.\n\nAfter completing treatment at the established phase 2 dose, subjects will receive surgery, radiotherapy alone, or chemotherapy with radiotherapy together based on how their tumor responds to the medications.","label":"Phase 2: Efficacy Arm 2 - HB-201 and HB-202 + Chemotherapy","type":"EXPERIMENTAL"}],"collaborators":[],"completion_date":{"date":"2027-01-01","type":"ESTIMATED"},"conditions":["Human Papilloma Virus","HPV","HPV Positive Oropharyngeal Squamous Cell Carcinoma","Head and Neck Cancer"],"enrollment":{"count":35,"type":"ACTUAL"},"has_results":false,"interventions":[{"name":"HB-201","otherNames":["TheraT® Vectors"],"type":"DRUG"},{"name":"HB-202","otherNames":["TheraT® Vectors"],"type":"DRUG"},{"name":"Carboplatin","otherNames":[],"type":"DRUG"},{"name":"Paclitaxel","otherNames":[],"type":"DRUG"},{"name":"Transoral Robotic Surgery","otherNames":["TORS"],"type":"PROCEDURE"}],"last_update":"2026-04-24","lead_sponsor":"University of Chicago","official_title":"A Randomized Phase I/II Trial of TheraT® Vectors Expressing HPV16 Specific Antigens in Combination With Neoadjuvant Chemotherapy Followed by Transoral Robotic Surgery or Risk/Response Stratified Chemoradiotherapy for Locoregional HPV16+ Oropharyngeal Cancer","overall_status":"ACTIVE_NOT_RECRUITING","phases":["PHASE1","PHASE2"],"primary_completion_date":{"date":"2027-01-01","type":"ESTIMATED"},"primary_outcomes":[{"measure":"Phase 1 Primary Outcome: Phase 1 Dose of HB-201 and HB-201/202 Combined with Chemotherapy","timeFrame":"2 years"},{"measure":"Phase 2 Primary Outcome: Deep Response Rate of Participants Treated with HB-201 or HB-201/202 Combined with Chemotherapy","timeFrame":"2 years"}],"references":[],"start_date":{"date":"2022-08-22","type":"ACTUAL"},"study_type":"INTERVENTIONAL","title":"TheraT® Vectors (Vaccines) Combined With Chemotherapy to Treat HPV16 Head and Neck Cancers","url":"https://clinicaltrials.gov/study/NCT05108870"},"report":null,"schema_id":"erudio.trial_listing","schema_version":"3.0","state":"listed","state_text":"No report yet. It can be ordered.","url":"https://www.erudio.com/trials/target-hpv-nct05108870"}