A Study to Evaluate Lenti-HPV-07 Immunotherapy Against HPV+ Cervical or Oropharyngeal Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Two IM injections Lenti-HPV-07, One IM injection Lenti-HPV-07.
- Who it may be relevant to
- Registry conditions: HPV-Related Cervical Carcinoma, HPV Positive Oropharyngeal Squamous Cell Carcinoma. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
An Open-Label Phase 1/2a Clinical Trial to Evaluate the Safety, Immunogenicity, and Preliminary Efficacy of a Lentiviral Vector-Based Therapeutic Vaccine Against Human Papilloma Virus (Lenti-HPV-07) in Participants With HPV-Associated Oropharyngeal Squamous Cell Cancer or Cervical Cancer
Overview
The goal of this clinical trial is to learn about the safety and efficacy of a potential new treatment called Lenti-HPV-07 in patients with a cancer induced by Human Papilloma Virus (HPV). The main questions aim to answer are: * Is Lenti-HPV-07 safe? * Does Lenti-HPV-07 induce an immune response? Participants will be assigned to a group based on their cancer type * either study drug group A: recurrent and/or metastatic cancer * or study drug group B: newly diagnosed with locally advanced cancer After they finish the study treatment, they will be followed for up to 1 year. Follow-up visits will occur via clinic visits or phone calls 4 weeks after the last study treatment and then quarterly for up to 1 year.
Detailed description
As of 06Nov2025 the recruitment in ARm A of the study (recurrent/metastatic cancers) has been closed to further enrollment, in accordance with the protocol and the study's prespecified operational and/or scientific considerations. No new participants will be enrolled into Arm A, and no additional study drug will be administered within this arm.
Interventions
- Drug Two IM injections Lenti-HPV-07
two Lenti-HPV-07 intramuscular injections one month apart - Drug One IM injection Lenti-HPV-07
a single intramuscular injection prior to receiving a standard of care 28 days at least after the injection.
Primary outcome measures
- Safety and Tolerability [Time frame: 12 months after last injection]
- OBD [Time frame: 28 days after last injection]
Secondary outcome measures (2)
- Immunogenicity [Time frame: 12 months after last injection]
- PD-L1 expression [Time frame: 12 months after last injection]
Eligibility criteria
Inclusion criteria
- histologically confirmed invasive HPV-related oropharyngeal or cervical cancer
- ECOG performance status of 0 or 1
- adequate hepatic, renal, pulmonary, and bone marrow/hematological function
Exclusion criteria
\- with seropositivity for HIV, active hepatitis C virus (HCV) infection, or hepatitis B (HBV) infection
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Sequential
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 4 centers
- Florida Cancer Specialists (from Sarah Canon research Institute) — Orlando
- Tampa General Hospital — Tampa
- Moffitt Cancer Center — Tampa
- Oklahoma Cancer Specialists and Research Institute, LLC — Tulsa
Identifiers
NCT: NCT06319963 · Lenti-HPV-07-CT01