RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

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

Quick Facts

Study Start:2024-08-08
Study Completion:2026-12
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06319963

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * histologically confirmed invasive HPV-related oropharyngeal or cervical cancer
  2. * ECOG performance status of 0 or 1
  3. * adequate hepatic, renal, pulmonary, and bone marrow/hematological function
  1. Pregnancy or breastfeeding
  2. Severe psychiatric disorders
  3. Active substance abuse
  4. Unstable medical conditions
  5. Inability to comply with study requirements

Contacts and Locations

Study Contact

Daniel Loera
CONTACT
713-256-8202
dloera@oncobay.com

Study Locations (Sites)

Florida Cancer Specialists (from Sarah Canon research Institute)
Orlando, Florida, 32827
United States
Tampa General Hospital
Tampa, Florida, 33606
United States
Moffitt Cancer Center
Tampa, Florida, 33612
United States

Collaborators and Investigators

Sponsor: Theravectys S.A.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-08-08
Study Completion Date2026-12

Study Record Updates

Study Start Date2024-08-08
Study Completion Date2026-12

Terms related to this study

Keywords Provided by Researchers

  • HPV16
  • Cervical Cancer
  • Oropharyngeal cancer
  • Immuno-oncotherapy
  • Head and Neck Cancers
  • T-cell vaccine
  • Lentiviral Vector
  • Anti-tumor immunity
  • Early E- and E7 antigens
  • HPV18
  • Human Papillomavirus

Additional Relevant MeSH Terms

  • HPV-Related Cervical Carcinoma
  • HPV Positive Oropharyngeal Squamous Cell Carcinoma