A Phase I/II Study of TheraT® Vector(s) Expressing Human Papillomavirus 16 Positive (HPV 16+) Specific Antigens in Patients with HPV 16+ Confirmed Cancers

UVA Tracking #
HSR220352
Principal Investigator
Varinder Kaur
Contact
Contact Phone
Official Trial Title
A Phase I/II Study of TheraT® Vector(s) Expressing Human Papillomavirus 16 Positive (HPV 16+) Specific Antigens in Patients with HPV 16+ Confirmed Cancers
Study Description

The University of Virginia Comprehensive Cancer Center seeks adults ages 18 and over with HPV 16+ confirmed head and neck squamous cell carcinoma(HNSCC) for the H-200-001 research study.
The Phase 2 H-200-001 Study is looking at 2 investigational study drugs, called HB-201 and HB-202, to see how well they work and how safe they are when given with pembrolizumab to patients with HPV 16+ HNSCC. These drugs are believed to stimulate the immune cells to help attack and kill HPV 16 cancer cells.
*To take part in this study, your head and neck cancer must be HPV 16+. If the study center tests you now, you will find out if your tumor is HPV 16+. This is called “pre-screening.”
• You can have this test done at any time, including if you are newly diagnosed or undergoing initial treatment. All the tests are done at no cost to you, and you do not have to take part in the study even if you take part in pre-screening.
• If your tumor is HPV 16+, you can have further tests to see if you can take part in the study now or in the future. This is called “screening.”

If your cancer is HPV 16+ and you decide to take part in the H-200-001 study, you will receive the investigational drugs in combination with the FDA-approved drug, pembrolizumab.

The H-200-001 study will involve:
• Receiving the investigational drugs, as well as coming in for study visits, which include exams, laboratory tests, and procedures such as having your blood drawn, and talking to the study doctor.
• Participation in the study includes, a screening visit, a treatment period, an end of treatment visit, a safety follow-up visit, and a follow-up period via phone calls to keep track of how you are doing. The treatment period will be given in “cycles”.
• The length of treatment cycles for this study and number of visits per cycle will vary based on what regimen of the study drugs you are placed in. You will continue to receive cycles of treatment until your cancer worsens or you experience any unacceptable side effects.
• The investigational drug, HB-201 and HB-202, as well as study related doctor's visits and laboratory tests, will be provided at no cost to you.

Additional information can be found here:
https://clinicaltrials.gov/ct2/show/NCT04180215?term=H-200-001&draw=2&r…

uvacancertrials@hscmail.mcc.virginia.edu

Compensation

$78 per visit Hotel: up to $260 per night