RecruitingPhase 1Phase 2NCT05108870

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

Sponsor

University of Chicago

Enrollment

98 participants

Start Date

Jul 17, 2024

Study Type

INTERVENTIONAL

Conditions

Head and Neck Cancer HPV Positive Oropharyngeal Squamous Cell Carcinoma Human Papilloma Virus HPV

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing TheraT® therapeutic vaccines combined with standard chemotherapy and radiation for people with HPV16-positive oropharyngeal (throat) cancer, to see whether the vaccine can boost immune response and improve treatment outcomes. **You may be eligible if...** - You are 18 years or older - You have been diagnosed with HPV16-positive squamous cell carcinoma of the oropharynx (throat), confirmed by lab testing - Your cancer has been staged according to AJCC 8th edition criteria - Sufficient tumor tissue (at least 10 slides) is available, or you can undergo a new biopsy **You may NOT be eligible if...** - Your cancer is not HPV16-positive - Sufficient tumor tissue is unavailable and you cannot undergo a biopsy - You have serious medical conditions that would prevent safe participation - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGHB-201

A anti-cancer vaccine that treats HPV-related cancers.

DRUGHB-202

A anti-cancer vaccine that treats HPV-related cancers.

DRUGCarboplatin

Chemotherapy drug.

DRUGPaclitaxel

Chemotherapy drug.

PROCEDURETransoral 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.