Trials / Not Yet Recruiting
Not Yet RecruitingNCT05108870
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
- Status
- Not Yet Recruiting
- Phase
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- 98 (estimated)
- Sponsor
- University of Chicago · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | HB-201 | A anti-cancer vaccine that treats HPV-related cancers. |
| DRUG | HB-202 | A anti-cancer vaccine that treats HPV-related cancers. |
| DRUG | Carboplatin | Chemotherapy drug. |
| DRUG | Paclitaxel | Chemotherapy drug. |
| PROCEDURE | Transoral Robotic Surgery | 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. |
Timeline
- Start date
- 2026-07-17
- Primary completion
- 2027-01-01
- Completion
- 2027-01-01
- First posted
- 2021-11-05
- Last updated
- 2026-03-25
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT05108870. Inclusion in this directory is not an endorsement.