TheraT® Vectors (Vaccines) Combined With Chemotherapy to Treat HPV16 Head and Neck Cancers
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
1 other identifier
interventional
35
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started Aug 2022
Longer than P75 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 25, 2021
CompletedFirst Posted
Study publicly available on registry
November 5, 2021
CompletedStudy Start
First participant enrolled
August 22, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
January 1, 2027
April 24, 2026
April 1, 2026
4.4 years
October 25, 2021
April 22, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Phase 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
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).
2 years
Secondary Outcomes (6)
Correlation Between Plasma HPV-DNA and Tumor HPV-DNA
2 years
Changes in Plasma HPV-DNA During Study Treatment with HB-201 and Alternating HB201/202 Combined with Chemotherapy
2 years
Pathologic Response in Participants Undergoing Transoral Robotic Surgery (TORS)
2 years
Progression Free Survival
2 years
Overall Survival
2 years
- +1 more secondary outcomes
Study Arms (4)
Phase 1: Dose-Finding Group 1 - Drug Combination 1
EXPERIMENTALAll 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
EXPERIMENTALAll 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
EXPERIMENTALParticipants 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
EXPERIMENTALParticipants 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.
Interventions
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.
Eligibility Criteria
You may qualify if:
- Subjects must have clinically confirmed human papilloma virus (HPV)16-positive head and neck squamous cell carcinoma of the oropharynx. Confirmed HPV-positive disease of other subsites are uncommon but also eligible.
- Must have HPV16 subtype demonstrated based on clinical guidelines established by the study doctor.
- Availability of ≥10 unstained 5 micron slides (to be provided to Human Tissue Resource Center at the University of Chicago). Participants who cannot fulfill this requirement will need to undergo a new biopsy prior to enrollment on study.
- Participants must be at least 18 years of age.
- Subjects with American Joint Committee on Cancer (8th edition, 2018) N1 (solitary lymph node \>=3cm), N2-N3 nodal disease or T3-T4 primary tumor (with any N).
- Measurable disease (either primary site and/or nodal disease) by Response Evaluation Criteria in Solid Tumors 1.1.
- No previous radiation or chemotherapy for a head and neck cancer.
- No complete surgical resection for a head and neck cancer within 8 weeks of enrollment (although lymph node biopsy including excision of an individual node with presence of residual nodal disease, or surgical biopsy/excision of the tumor with residual measurable disease is acceptable.) No surgical procedures or biopsies will occur after baseline scans are performed and measurable lesions are identified.
- Eastern Cooperative Oncology Group performance status 0-1
- Normal Organ Function as confirmed by clinical lab values.
- Must be considered to be a candidate to receive cisplatin by the treating physician.
- Must sign a study-specific informed consent form prior to study entry. Patients should have the ability to understand and the willingness to sign a written informed consent document.
- Women of childbearing potential must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG) within 24 hours prior to the start of study drug.
- Women must not be breastfeeding.
- Women of childbearing potential must agree to follow instructions for method(s) of contraception for the duration of treatment.
- +1 more criteria
You may not qualify if:
- Unequivocal demonstration of distant metastatic disease (M1 disease).
- Non-HPV16 subtype.
- Unidentifiable primary site.
- Intercurrent medical illnesses that impairs the patient's tolerance to therapy or limits survival. This includes but is not limited to ongoing or active infection, immunodeficiency, symptomatic congestive heart failure, pulmonary dysfunction, cardiomyopathy, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance. Patients with clinically stable and/or chronically managed medical illnesses that are not symptomatic and/or are not expected to impact treatment on protocol are still eligible (conditions to be reviewed by the PI to confirm eligibility).
- Active, known, or suspected, autoimmune or inflammatory disorders requiring immunosuppressive therapy, with the exception of low-dose prednisone (\<= 10mg or equivalent). The following are exceptions to these criteria:
- Patients with vitiligo or alopecia.
- Patients with hypothyroidism (e.g., following Hashimoto syndrome) stable on hormone replacement.
- Any chronic skin condition that does not require systemic treatment.
- Treatment with any chronic immunosuppressive medication within six months prior to the first administration of study treatment (unless agreed otherwise).
- Participants who have had a prior anaphylactic or other severe reaction to human immunoglobulin or antibody formulation administration.
- Herbal remedies with immune-stimulating properties or known to potentially interfere with major organ function within 28 days prior to the first dose of study treatment, unless agreed otherwise with the primary investigator.
- Prior surgical therapy other than incisional/excisional biopsy or organ-sparing procedures such as debulking of airway-compromising tumors. Residual measurable tumor is required for enrollment as discussed above.
- Participants receiving other investigational agents.
- Prior systemic anti-cancer treatment within the last 8 weeks.
- Has a known additional malignancy that is progressing or requires active treatment. Exceptions include basal cell carcinoma of the skin or squamous cell carcinoma of the skin that has undergone potentially curative therapy or in situ cervical cancer or any tumors that are not likely to influence life expectancy in the subsequent 3 years without active treatment.
- +3 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Chicago
Chicago, Illinois, 60637, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ari Rosenberg, MD
University of Chicago - Comprehensive Cancer Center
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 25, 2021
First Posted
November 5, 2021
Study Start
August 22, 2022
Primary Completion (Estimated)
January 1, 2027
Study Completion (Estimated)
January 1, 2027
Last Updated
April 24, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will share