Health TrialsbyHealthPanel

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

ConditionHepatocellular 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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • Atezolizumab

    Drug

    1200 mg IV every 3 weeks until disease progression or unacceptable toxicity

  • Bevacizumab

    Drug

    15 mg/kg IV every 3 weeks until disease progression or unacceptable toxicity

  • UCPVax

    Drug

    UCPVax vaccine (combined with Montanide ISA51 as adjuvant) at 0.5 mg subcutaneously

Treatment groups

105 Participants
are divided into 2 treatment groups
Group A: Experimental Arm (Arm A)Experimental treatment 3 interventions
Group B: Control Arm (Arm B)Other 2 interventions

Trial outcomes

Primary outcomes

1

objective response rate (ORR)

addition of complete response (CR) and partial response (PR) rates, evaluated by mRECIST criteria

Time frame
at 6 months

Secondary outcomes

1

overall survival (OS)

delay from the date of randomization to death from any cause.

Time frame
through study completion, an average of 2 years
2

progression-free-survival (PFS)

delay from the date of randomization to the disease progression or death from any cause whichever occurs first

Time frame
through study completion, an average of 2 years
3

disease control rate (DCR)

addition of complete response (CR), partial response (PR), and stable disease (SD) rates, evaluated by RECIST criteria v1.1 and imRECIST

Time frame
at 6 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Centre Hospitalier Universitaire de Besancon

Lead sponsor

GERCOR - Multidisciplinary Oncology Cooperative Group

Collaborator

PRODIGE

Collaborator

Source ClinicalTrials.gov
Apply now