Evaluation of the Interest to Combine a CD4 Th1-inducer Cancer Vaccine Derived From Telomerase and Atezolizumab Plus Bevacizumab in Unresectable Hepatocellular Carcinoma

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorCentre Hospitalier Universitaire de Besancon

About this trial

The TERTIO trial will propose to determine the clinical interest and immunological efficacy of a treatment combining the CD4 helper T-inducer cancer anti-telomerase vaccine (UCPVax) with anti-PD-L1 therapy (atezolizumab) and bevacizumab in unresectable HCC by evaluation of the objective response rate at 6 months (randomized phase II, 10 centers, 105 patients)

Eligibility criteria

Qualifiers

Signed informed consent

Histologically confirmed hepatocellular carcinoma

Locally advanced, metastatic, or unresectable disease

Patient who had not previously received systemic anti-cancer treatment

Disqualifiers

Patients previously exposed to anti-tumor immunotherapy as anti-PD-1, anti-PD-L1, or anti-CTLA4 agent or any immune therapy.

Diagnosis of additional malignancy within 3 years prior to the inclusion with the exception of curatively treated basal cell carcinoma of the skin and/or curatively resected in situ cervical or breast cancer

Patient with any medical or psychiatric condition or disease, which would make the patient inappropriate for entry into this study

Current participation in a study of an investigational agent or in the period of exclusion

Trial design

Treatments tested in this trial

  • Atezolizumab
  • Bevacizumab
  • UCPVax

Treatment groups

105 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Centre Hospitalier Universitaire de Besancon

Lead sponsor

GERCOR - Multidisciplinary Oncology Cooperative Group

Collaborator

PRODIGE

Collaborator