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NCT06319963 | RECRUITING | HPV-Related Cervical Carcinoma

A Study to Evaluate Lenti-HPV-07 Immunotherapy Against HPV+ Cervical or Oropharyngeal Cancer
Sponsor:

Theravectys S.A.

Brief Summary:

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.

Condition or disease

HPV-Related Cervical Carcinoma

HPV Positive Oropharyngeal Squamous Cell Carcinoma

Intervention/treatment

Two IM injections Lenti-HPV-07

One IM injection Lenti-HPV-07

Phase

PHASE1

PHASE2

Study Type : INTERVENTIONAL
Estimated Enrollment : 72 participants
Masking : NONE
Primary Purpose : TREATMENT
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
Actual Study Start Date : 2024-08-08
Estimated Primary Completion Date : 2025-12
Estimated Study Completion Date : 2026-12

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
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
A Study to Evaluate Lenti-HPV-07 Immunotherapy Against HPV+ Cervical or Oropharyngeal Cancer

Location Details

NCT06319963

Please Choose a site

How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

RECRUITING

United States, Florida

Florida Cancer Specialists (from Sarah Canon research Institute)

Orlando, Florida, United States, 32827

RECRUITING

United States, Florida

Tampa General Hospital

Tampa, Florida, United States, 33606

RECRUITING

United States, Florida

Moffitt Cancer Center

Tampa, Florida, United States, 33612

RECRUITING

United States, Oklahola

Oklahoma Cancer Specialists and Research Institute, LLC

Tulsa, Okholohan, United States, 74146