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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
98
A anti-cancer vaccine that treats HPV-related cancers.
A anti-cancer vaccine that treats HPV-related cancers.
Chemotherapy drug.
Chemotherapy drug.
Transoral robotic surgery is a procedure to remove mouth and throat cancers in which a surgeon uses a sophisticated, computer-enhanced system to guide the surgical tools.
University of Chicago
Chicago, Illinois, United States
RECRUITINGPhase 1 Primary Outcome: Phase 1 Dose of HB-201 and HB-201/202 Combined with Chemotherapy
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
Time frame: 2 years
Phase 2 Primary Outcome: Deep Response Rate of Participants Treated with HB-201 or HB-201/202 Combined with Chemotherapy
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).
Time frame: 2 years
Correlation Between Plasma HPV-DNA and Tumor HPV-DNA
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.
Time frame: 2 years
Changes in Plasma HPV-DNA During Study Treatment with HB-201 and Alternating HB201/202 Combined with Chemotherapy
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.
Time frame: 2 years
Pathologic Response in Participants Undergoing Transoral Robotic Surgery (TORS)
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.
Time frame: 2 years
Progression Free Survival
Progression-free survival of participants as assessed by data recorded in study/clinical records and statistical analysis.
Time frame: 2 years
Overall Survival
Overall survival of participants as assessed by data recorded in study/clinical records and statistical analysis.
Time frame: 2 years
Locoregional Control
Locoregional control of participants as assessed by data recorded in study/clinical records and statistical analysis.
Time frame: 2 years
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