A Study to Evaluate Lenti-HPV-07 Immunotherapy Against HPV+ Cervical or Oropharyngeal Cancer
HPV-Related Cervical Carcinoma · HPV Positive Oropharyngeal Squamous Cell Carcinoma
What this study involves
The registry says this study is recruiting. Individual locations may have different availability.
- Study type
- Interventional
- Phase
- Phase 1 / Phase 2
- Age range
- 18 years - Not specified
- Sex eligible
- All sexes
- Healthy volunteers
- Not accepted
- Participants
- 72 Estimated
These are starting points, not an eligibility decision. The research team must review the full requirements.
About the research
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.
Read the full 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.
Who may be able to participate?
The list below is the sponsor’s full registry wording. It can include conditions, prior treatment, test results and other requirements. A match in search does not mean you qualify.
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
Understand screeningTreatment, groups and participation
The registry may describe treatments and study duration without a complete visit calendar. Ask the study team for the exact schedule, procedures, risks, costs and alternatives. Keep your usual care plan unless your treating clinician tells you otherwise.
- Assignment
- Not randomized
- Masking
- No masking
Arm A : Refractory newly diagnosed
Refractory recurrent and/or metastatic cervical or oropharyngeal cancer that is not amenable to local therapy with curative intent (ie, surgery or radiation therapy with or without chemotherapy).
Drug: Two IM injections Lenti-HPV-07
Arm B : newly diagnosed locally advanced
Participants who have newly diagnosed locally advanced HPV-related oropharyngeal cancer (defined by AJCC 8th edition \[ie, T1-2N2-N3, T3-T4N0-N3\]) or cervical cancer (stages IB to IVA) that has never been treated with curative intent, and who are candidates to begin an SoC treatment (surgery, radiation therapy with or without chemotherapy).
Drug: One IM injection Lenti-HPV-07
Two IM injections Lenti-HPV-07 DRUG
two Lenti-HPV-07 intramuscular injections one month apart
One IM injection Lenti-HPV-07 DRUG
a single intramuscular injection prior to receiving a standard of care 28 days at least after the injection.
What researchers are measuring
Outcome measures describe what is being studied. They are not proof that a treatment works.
Primary measures
Safety and Tolerability
Time frame: 12 months after last injection
Frequency, intensity, and relationship of adverse events with vaccine administration per CTCAE v5.0
OBD
Time frame: 28 days after last injection
To identify the optimal biological dose (OBD) and schedule for subsequent trials of Lenti-HPV-07
Secondary measures
Immunogenicity
Time frame: 12 months after last injection
- measure of CD4+ and CD8+ T cell responses specific to E6 or E7 from HPV16 and HPV18 in PBMC
- repertoire and clonotype tracking, and cytometric analysis of T cell activation/effector/memory marker
PD-L1 expression
Time frame: 12 months after last injection
PD-L1 tumor expression, as measured by composite positive score, by 50% both pre- and post-injection
Review the complete result tables and limitations in the official record.
Open official results ↗Research locations (4)
The overall study status and a local site’s status can differ. Confirm that location’s availability before traveling.
4 locations
Florida Cancer Specialists (from Sarah Canon research Institute)Orlando, Florida, United StatesRecruiting
Tampa General HospitalTampa, Florida, United StatesRecruiting
Moffitt Cancer CenterTampa, Florida, United StatesRecruiting
Oklahoma Cancer Specialists and Research Institute, LLCTulsa, Oklahoma, United StatesRecruiting
Study team and timeline
- Lead sponsor
- Theravectys S.A.
- Study start
- Aug 8, 2024 Actual
- Primary completion
- 2026-12 Estimated
- Study completion
- 2026-12 Estimated
- First posted
- Mar 20, 2024 Actual
- Last updated
- Nov 10, 2026 Actual
Official study contacts
Official study 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
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Source: ClinicalTrials.gov API v2. Information is submitted by sponsors and investigators. NLM does not approve the safety or science of all listed studies. Registry disclaimer.
Retrieved: Nov 12, 2026 · Last registry update: Nov 10, 2026