RecruitingPhase 2NCT05528952

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

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)


Sponsor

Centre Hospitalier Universitaire de Besancon

Enrollment

105 participants

Start Date

Sep 27, 2022

Study Type

INTERVENTIONAL

Conditions

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)


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a combination of an experimental cancer vaccine (designed to activate immune cells against a protein called telomerase, which is active in many cancer cells) along with two standard immunotherapy drugs — atezolizumab and bevacizumab — in people with advanced liver cancer (hepatocellular carcinoma, or HCC) that cannot be surgically removed. **You may be eligible if...** - You are 18 or older with confirmed, unresectable advanced or metastatic liver cancer - You have not previously received systemic (whole-body) anti-cancer therapy - You have measurable disease and adequate liver function (Child-Pugh Class A) - Your cancer is at BCLC stage B (not eligible for local treatment) or stage C - You are in good physical condition (performance status below 2) **You may NOT be eligible if...** - You have previously received immunotherapy (anti-PD-1, anti-PD-L1, anti-CTLA-4, or any immune therapy) - You have been diagnosed with another cancer within the last 3 years (other than treated basal cell skin cancer or in-situ cervical/breast cancer) - You have a serious medical or psychiatric condition that would interfere with treatment Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGAtezolizumab

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

DRUGBevacizumab

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

DRUGUCPVax

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


Locations(14)

CHU de Besançon

Besançon, France

CH William Morey

Chalon-sur-Saône, France

Hôpital Henri Mondor

Créteil, France

Centre Georges François Leclerc

Dijon, France

Hôpital Nord Franche-Comté

Montbéliard, France

CHU de Montpellier

Montpellier, France

CH de Mulhouse

Mulhouse, France

Institut de Cancérologie de l'Ouest

Nantes, France

Centre Hospitalier Paris St Joseph

Paris, France

Groupe Hospitalier Paris Salpetrière

Paris, France

Hôpital BEAUJON

Paris, France

Institut Mutualiste Montsouris

Paris, France

CHU de Poitiers

Poitiers, France

Hôpital Paul Brousse

Villejuif, France

View Full Details on ClinicalTrials.gov

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NCT05528952


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