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

March 13, 2026 updated by: Centre Hospitalier Universitaire de Besançon

Evaluation of the Interest to Combine a CD4 Th1-inducer Cancer Vaccine Derived From Telomerase and Atezolizumab Plus Bevacizumab in Unresectable Hepatocellular Carcinoma: a Proof of Concept Randomized Phase II Study (TERTIO - Prodige 82)

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)

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

105

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • France
      • Besançon, France
        • Recruiting
        • CHU de Besançon
        • Contact:
          • Christophe BORG, Pr
      • Chalon-sur-Saône, France
        • Recruiting
        • CH William Morey
        • Contact:
          • Pierre Verdier-Davioud, Dr
      • Créteil, France
        • Recruiting
        • Hôpital Henri Mondor
        • Contact:
          • Hélène REGNAULT, Dr
      • Dijon, France
        • Recruiting
        • Centre Georges Francois Leclerc
        • Contact:
          • François GHIRINGHELLI, Pr
      • Montbéliard, France
        • Recruiting
        • Hôpital Nord Franche-Comté
        • Contact:
          • Serge FRATTE, Dr
      • Montpellier, France
        • Recruiting
        • CHU de Montpellier
        • Contact:
          • Eric ASSENAT, Pr
      • Mulhouse, France
        • Recruiting
        • CH de Mulhouse
        • Contact:
          • Stephanie HUSSON-WETZEL, Dr
      • Nantes, France
        • Not yet recruiting
        • Institut de Cancérologie de l'Ouest
        • Contact:
          • Amélie MALLET, Dr
      • Paris, France
        • Not yet recruiting
        • Centre Hospitalier Paris St Joseph
        • Contact:
          • Eric RAYMOND, Pr
      • Paris, France
        • Recruiting
        • Institut Mutualiste Montsouris
        • Contact:
          • Emilie SOULARUE, Dr
      • Paris, France
        • Recruiting
        • Hôpital Beaujon
        • Contact:
          • Mohamed BOUATTOUR, Dr
      • Paris, France
        • Recruiting
        • Groupe Hospitalier Paris Salpetrière
        • Contact:
          • Manon ALLAIRE, Dr
      • Poitiers, France
        • Not yet recruiting
        • CHU de Poitiers
        • Contact:
          • Valentin ROLLE, Dr
      • Villejuif, France
        • Recruiting
        • Hopital Paul Brousse
        • Contact:
          • Pascal HAMMEL, Dr
        • Contact:
          • Olivier ROSMORDUC, Dr

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.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Main inclusion Criteria:

  1. Signed informed consent
  2. Histologically confirmed hepatocellular carcinoma
  3. Locally advanced, metastatic, or unresectable disease
  4. Patient who had not previously received systemic anti-cancer treatment
  5. Age ≥ 18 years
  6. Measurable disease defined according to mRECIST guidelines (Note: Previously irradiated lesions can be considered as measurable disease only if disease progression has been unequivocally documented at that site since radiation.)
  7. Patients who have received previous chemoembolization, radioembolization and/or radiotherapy should have recovered from any treatment related toxicity, to a level of ≤ grade 1 (according to National Cancer Institute [NCI] common terminology criteria for adverse events, version 5 (CTCAE v5) with the exception of Grade 2 alopecia
  8. Performance status < 2
  9. Child-Pugh Class A status
  10. BCLC C stage or BCLC B stage not eligible to loco-regional therapy according to the Barcelona Clinic Liver Cancer (BCLC) staging system

Main exclusion Criteria:

Non-eligible to a clinical trial:

  1. Patients previously exposed to anti-tumor immunotherapy as anti-PD-1, anti-PD-L1, or anti-CTLA4 agent or any immune therapy.
  2. 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
  3. Patient with any medical or psychiatric condition or disease, which would make the patient inappropriate for entry into this study
  4. Current participation in a study of an investigational agent or in the period of exclusion

  5. Patient under guardianship, curatorship or under the protection of justice

    Cancer-specific exclusion criteria:

  6. Know fibrolamellar HCC, sarcomatoid HCC, or mixed cholangiocarcinoma and HCC
  7. Uncontrolled pleural effusion, pericardial effusion, ascites or symptomatic fistula
  8. Uncontrolled tumor-related pain: exposing patients to risk of exposure to corticoids or iterative hospitalizations. Symptomatic lesions amenable to palliative radiotherapy should be treated prior to inclusion. Patients should be recovered from the effects of radiation. There is no required minimum recovery period

  9. Known active central nervous system metastases and/or carcinomatous meningitis. Subject with previously treated brain metastases and with radiological and clinical stability are allowed

    Non-eligible to treatment:

  10. History of encephalopathy
  11. Prior bleeding event due to untreated or incompletely treated esophageal and/or gastric varices within 6 months prior to randomization
  12. Inadequate organ functions: known cardiac failure of unstable coronaropathy, respiratory failure, or uncontrolled infection or another life-risk condition

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Experimental Arm (Arm A)
Atezolizumab + Bevacizumab + UCPVax
Drug: Atezolizumab
1200 mg IV every 3 weeks until disease progression or unacceptable toxicity
Drug: Bevacizumab
15 mg/kg IV every 3 weeks until disease progression or unacceptable toxicity
Drug: UCPVax
UCPVax vaccine (combined with Montanide ISA51 as adjuvant) at 0.5 mg subcutaneously
Other: Control Arm (Arm B)
Atezoliumab + Bevacizumab
Drug: Atezolizumab
1200 mg IV every 3 weeks until disease progression or unacceptable toxicity
Drug: Bevacizumab
15 mg/kg IV every 3 weeks until disease progression or unacceptable toxicity

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
objective response rate (ORR)
Time Frame: at 6 months
addition of complete response (CR) and partial response (PR) rates, evaluated by mRECIST criteria
at 6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
overall survival (OS)
Time Frame: through study completion, an average of 2 years
delay from the date of randomization to death from any cause.
through study completion, an average of 2 years
progression-free-survival (PFS)
Time Frame: through study completion, an average of 2 years
delay from the date of randomization to the disease progression or death from any cause whichever occurs first
through study completion, an average of 2 years
disease control rate (DCR)
Time Frame: at 6 months
addition of complete response (CR), partial response (PR), and stable disease (SD) rates, evaluated by RECIST criteria v1.1 and imRECIST
at 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Universitaire de Besançon

Collaborators

GERCOR - Multidisciplinary Oncology Cooperative Group
PRODIGE

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 Major Dates

Study Start (Actual)

September 27, 2022

Primary Completion (Estimated)

March 27, 2028

Study Completion (Estimated)

February 27, 2030

Study Registration Dates

First Submitted

September 1, 2022

First Submitted That Met QC Criteria

September 1, 2022

First Posted (Actual)

September 6, 2022

Study Record Updates

Last Update Posted (Actual)

March 16, 2026

Last Update Submitted That Met QC Criteria

March 13, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2022/680

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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