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

Sponsor
Centre Hospitalier Universitaire de Besancon
Study ID
NCT05528952
Phase
PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • 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

Study Details

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)

Key Dates

Start date
Sep 27, 2022
Status verified
Mar 2026
Primary completion
Mar 27, 2028
Completion
Feb 27, 2030

Study Design

Enrollment
105 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Experimental Arm (Arm A)
    Atezolizumab + Bevacizumab + UCPVax
  • Other: Control Arm (Arm B)
    Atezoliumab + Bevacizumab

Primary Outcome Measure

objective response rate (ORR) [ Time Frame: at 6 months ]

Central Contacts

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