A Study to Evaluate Lenti-HPV-07 Immunotherapy Against HPV+ Cervical or Oropharyngeal Cancer
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorTheravectys S.A.
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
None
Trial design
Design model
Sequential
Treatments tested in this trial
Two IM injections Lenti-HPV-07
Drugtwo Lenti-HPV-07 intramuscular injections one month apart
One IM injection Lenti-HPV-07
Druga single intramuscular injection prior to receiving a standard of care 28 days at least after the injection.
Treatment groups
72 Participants
are divided into 2 treatment groupsGroup A: Arm A : Refractory newly diagnosedExperimental treatment 1 intervention
Group B: Arm B : newly diagnosed locally advancedExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Safety and Tolerability
Frequency, intensity, and relationship of adverse events with vaccine administration per CTCAE v5.0
Time frame
12 months after last injection2
OBD
To identify the optimal biological dose (OBD) and schedule for subsequent trials of Lenti-HPV-07
Time frame
28 days after last injectionSecondary outcomes
1
Immunogenicity
* 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
Time frame
12 months after last injection2
PD-L1 expression
PD-L1 tumor expression, as measured by composite positive score, by 50% both pre- and post-injection
Time frame
12 months after last injectionSponsors and contacts
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Source ClinicalTrials.gov