NCT05528952

Brief Summary

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)

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
105

participants targeted

Target at P75+ for phase_2 hepatocellular-carcinoma

Timeline
46mo left

Started Sep 2022

Longer than P75 for phase_2 hepatocellular-carcinoma

Geographic Reach
1 country

14 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress49%
Sep 2022Feb 2030

First Submitted

Initial submission to the registry

September 1, 2022

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 6, 2022

Completed
21 days until next milestone

Study Start

First participant enrolled

September 27, 2022

Completed
5.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 27, 2028

Expected
1.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 27, 2030

Last Updated

March 16, 2026

Status Verified

March 1, 2026

Enrollment Period

5.5 years

First QC Date

September 1, 2022

Last Update Submit

March 13, 2026

Conditions

Hepatocellular Carcinoma

Keywords

CD4 Th1-inducer cancer vaccine

Outcome Measures

Primary Outcomes (1)

  • objective response rate (ORR)

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

    at 6 months

Secondary Outcomes (3)

  • overall survival (OS)

    through study completion, an average of 2 years

  • progression-free-survival (PFS)

    through study completion, an average of 2 years

  • disease control rate (DCR)

    at 6 months

Study Arms (2)

Experimental Arm (Arm A)

EXPERIMENTAL

Atezolizumab + Bevacizumab + UCPVax

Drug: AtezolizumabDrug: BevacizumabDrug: UCPVax

Control Arm (Arm B)

OTHER

Atezoliumab + Bevacizumab

Drug: AtezolizumabDrug: Bevacizumab

Interventions

AtezolizumabDRUG

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

Control Arm (Arm B)Experimental Arm (Arm A)
BevacizumabDRUG

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

Control Arm (Arm B)Experimental Arm (Arm A)
UCPVaxDRUG

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

Experimental Arm (Arm A)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Signed informed consent
  • Histologically confirmed hepatocellular carcinoma
  • Locally advanced, metastatic, or unresectable disease
  • Patient who had not previously received systemic anti-cancer treatment
  • Age ≥ 18 years
  • 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.)
  • 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
  • Performance status \< 2
  • Child-Pugh Class A status
  • BCLC C stage or BCLC B stage not eligible to loco-regional therapy according to the Barcelona Clinic Liver Cancer (BCLC) staging system

You may not qualify if:

  • Non-eligible to a clinical trial:
  • Patients previously exposed to anti-tumor immunotherapy as anti-PD-1, anti-PD-L1, or anti-CTLA4 agent or any immune therapy.
  • Patient with any medical or psychiatric condition or disease, which would make the patient inappropriate for entry into this study
  • Patient under guardianship, curatorship or under the protection of justice
  • Know fibrolamellar HCC, sarcomatoid HCC, or mixed cholangiocarcinoma and HCC
  • Uncontrolled pleural effusion, pericardial effusion, ascites or symptomatic fistula
  • 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:
  • History of encephalopathy
  • Prior bleeding event due to untreated or incompletely treated esophageal and/or gastric varices within 6 months prior to randomization
  • Inadequate organ functions: known cardiac failure of unstable coronaropathy, respiratory failure, or uncontrolled infection or another life-risk condition

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (14)

CHU de Besançon

Besançon, France

RECRUITING

CH William Morey

Chalon-sur-Saône, France

RECRUITING

Hôpital Henri Mondor

Créteil, France

RECRUITING

Centre Georges François Leclerc

Dijon, France

RECRUITING

Hôpital Nord Franche-Comté

Montbéliard, France

RECRUITING

CHU de Montpellier

Montpellier, France

RECRUITING

CH de Mulhouse

Mulhouse, France

RECRUITING

Institut de Cancérologie de l'Ouest

Nantes, France

NOT YET RECRUITING

Centre Hospitalier Paris St Joseph

Paris, France

NOT YET RECRUITING

Groupe Hospitalier Paris Salpetrière

Paris, France

RECRUITING

Hôpital BEAUJON

Paris, France

RECRUITING

Institut Mutualiste Montsouris

Paris, France

RECRUITING

CHU de Poitiers

Poitiers, France

NOT YET RECRUITING

Hôpital Paul Brousse

Villejuif, France

RECRUITING

Related Publications (1)

  • Vienot A, Jacquin M, Rebucci-Peixoto M, Pureur D, Ghiringhelli F, Assenat E, Hammel P, Rosmorduc O, Stouvenot M, Allaire M, Bouattour M, Regnault H, Fratte S, Raymond E, Soularue E, Husson-Wetzel S, Di Martino V, Muller A, Clairet AL, Fagnoni-Legat C, Adotevi O, Meurisse A, Vernerey D, Borg C. Evaluation of the interest to combine a CD4 Th1-inducer cancer vaccine derived from telomerase and atezolizumab plus bevacizumab in unresectable hepatocellular carcinoma: a randomized non-comparative phase II study (TERTIO - PRODIGE 82). BMC Cancer. 2023 Jul 29;23(1):710. doi: 10.1186/s12885-023-11065-0.

    PMID: 37516867BACKGROUND

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Interventions

atezolizumabBevacizumab

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsLiver NeoplasmsDigestive System NeoplasmsNeoplasms by SiteDigestive System DiseasesLiver Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Central Study Contacts

Borg Christophe, Pr

CONTACT

+33 3 81 47 99 99xtoph.borg@gmail.com

Angélique VIENOT, Dr

CONTACT

a3vienot@chu-besancon.fr

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 1, 2022

First Posted

September 6, 2022

Study Start

September 27, 2022

Primary Completion (Estimated)

March 27, 2028

Study Completion (Estimated)

February 27, 2030

Last Updated

March 16, 2026

Record last verified: 2026-03

Locations

FR(14)