TheraT® Vectors (Vaccines) Combined With Chemotherapy to Treat HPV16 Head and Neck Cancers
- Conditions
- HPV Positive Oropharyngeal Squamous Cell CarcinomaHead and Neck CancerHuman Papilloma VirusHPV
- Interventions
- Registration Number
- NCT05108870
- Lead Sponsor
- University of Chicago
- Brief Summary
Doctors leading this study hope to learn about the safety and effectiveness of combining medications HB-201 and HB-202 (also known as TheraT® vectors) with chemotherapy using carboplatin and paclitaxel in the beginning of the study (induction) and if combining these medications can increase tumor shrinkage after therapy and reduce the amount of radiotherapy and chemotherapy that will later be needed.
In addition, the study is looking at ways to reduce side effects overall using robotic surgery, chemotherapy and radiotherapy, or radiotherapy alone. Your participation in this research will last about 2 years.
HB-201 and HB-202 are experimental (meaning the US Food and Drug Administration (FDA) has not approved these drugs), and therefore they can only be given in a research study.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 98
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Phase 1: Dose-Finding Group 1 - Drug Combination 1 HB-201 All participants in this group will receive HB-201 combined with chemotherapy using carboplatin and paclitaxel. \- 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 Phase 1: Dose-Finding Group 1 - Drug Combination 1 HB-202 All participants in this group will receive HB-201 combined with chemotherapy using carboplatin and paclitaxel. \- 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 Phase 1: Dose-Finding Group 1 - Drug Combination 1 Carboplatin All participants in this group will receive HB-201 combined with chemotherapy using carboplatin and paclitaxel. \- 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 Phase 1: Dose-Finding Group 1 - Drug Combination 1 Paclitaxel All participants in this group will receive HB-201 combined with chemotherapy using carboplatin and paclitaxel. \- 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 Phase 1: Dose-Finding Group 2 - Drug Combination 2 HB-201 All participants in this group will receive alternating doses of HB-201 and HB-202 combined with chemotherapy using carboplatin and paclitaxel. Participants 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. Phase 1: Dose-Finding Group 2 - Drug Combination 2 HB-202 All participants in this group will receive alternating doses of HB-201 and HB-202 combined with chemotherapy using carboplatin and paclitaxel. Participants 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. Phase 1: Dose-Finding Group 2 - Drug Combination 2 Carboplatin All participants in this group will receive alternating doses of HB-201 and HB-202 combined with chemotherapy using carboplatin and paclitaxel. Participants 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. Phase 1: Dose-Finding Group 2 - Drug Combination 2 Paclitaxel All participants in this group will receive alternating doses of HB-201 and HB-202 combined with chemotherapy using carboplatin and paclitaxel. Participants 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. Phase 2: Efficacy Arm 1 - HB-201 + Chemotherapy HB-201 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. After 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. Phase 2: Efficacy Arm 1 - HB-201 + Chemotherapy HB-202 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. After 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. Phase 2: Efficacy Arm 1 - HB-201 + Chemotherapy Carboplatin 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. After 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. Phase 2: Efficacy Arm 1 - HB-201 + Chemotherapy Paclitaxel 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. After 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. Phase 2: Efficacy Arm 1 - HB-201 + Chemotherapy Transoral Robotic Surgery 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. After 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. Phase 2: Efficacy Arm 2 - HB-201 and HB-202 + Chemotherapy HB-201 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. After 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. Phase 2: Efficacy Arm 2 - HB-201 and HB-202 + Chemotherapy HB-202 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. After 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. Phase 2: Efficacy Arm 2 - HB-201 and HB-202 + Chemotherapy Carboplatin 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. After 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. Phase 2: Efficacy Arm 2 - HB-201 and HB-202 + Chemotherapy Paclitaxel 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. After 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. Phase 2: Efficacy Arm 2 - HB-201 and HB-202 + Chemotherapy Transoral Robotic Surgery 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. After 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.
- Primary Outcome Measures
Name Time Method Phase 2 Primary Outcome: Deep Response Rate of Participants Treated with HB-201 or HB-201/202 Combined with Chemotherapy 2 years The deep response rate (DRR) of participants who receive neoadjuvant HB-201 monotherapy combined with chemotherapy or alternating doses of HB-201 and HB-202 combined with chemotherapy. This response rate will be assessed by tumor shrinkage according to the Response Evaluation Criteria in Solid Tumors (RECIST 1.1).
Phase 1 Primary Outcome: Phase 1 Dose of HB-201 and HB-201/202 Combined with Chemotherapy 2 years The phase 1 dose of HB-201 monotherapy and alternating HB-201 and 202 therapy in combination with chemotherapy in patients with HPV 16 head and neck cancer as assessed by data on reported dose-limiting toxicities (side effects) among participants. These side effects will be measures according to the Common Terminology Criteria for Adverse Events version 5
- Secondary Outcome Measures
Name Time Method Correlation Between Plasma HPV-DNA and Tumor HPV-DNA 2 years Correlation between plasma HPV-DNA and tumor HPV-DNA as assessed by an analysis of plasma and sputum samples of participants using next generation sequencing analysis.
Pathologic Response in Participants Undergoing Transoral Robotic Surgery (TORS) 2 years Pathologic response in patients undergoing TORS following neoadjuvant HB-201 monotherapy and HB-202 alternating two-vector therapy combined with chemotherapy. Response will be assessed by tumor shrinkage according to Response Evaluation Criteria in Solid Tumors 1.1.
Progression Free Survival 2 years Progression-free survival of participants as assessed by data recorded in study/clinical records and statistical analysis.
Overall Survival 2 years Overall survival of participants as assessed by data recorded in study/clinical records and statistical analysis.
Changes in Plasma HPV-DNA During Study Treatment with HB-201 and Alternating HB201/202 Combined with Chemotherapy 2 years Changes in the amount of HPV-DNA found in plasma during neoadjuvant HB-201 monotherapy and HB-201 and HB-202 alternating two-vector therapy combined with chemotherapy as assessed by next generation sequencing analysis of participants' plasma samples.
Locoregional Control 2 years Locoregional control of participants as assessed by data recorded in study/clinical records and statistical analysis.
Trial Locations
- Locations (1)
University of Chicago
🇺🇸Chicago, Illinois, United States
University of Chicago🇺🇸Chicago, Illinois, United StatesClinical Trials IntakeContact855-702-8222cancerclinicaltrials@bsd.uchicago.eduAri Rosenberg, MDPrincipal Investigator