Trial Title:
Evaluation of the Interest to Combine a CD4 Th1-inducer Cancer Vaccine Derived From Telomerase and Atezolizumab Plus Bevacizumab in Unresectable Hepatocellular Carcinoma
NCT ID:
NCT05528952
Condition:
Hepatocellular Carcinoma
Conditions: Official terms:
Carcinoma
Carcinoma, Hepatocellular
Bevacizumab
Atezolizumab
Conditions: Keywords:
CD4 Th1-inducer cancer vaccine
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Atezolizumab
Description:
1200 mg IV every 3 weeks until disease progression or unacceptable toxicity
Arm group label:
Control Arm (Arm B)
Arm group label:
Experimental Arm (Arm A)
Intervention type:
Drug
Intervention name:
Bevacizumab
Description:
15 mg/kg IV every 3 weeks until disease progression or unacceptable toxicity
Arm group label:
Control Arm (Arm B)
Arm group label:
Experimental Arm (Arm A)
Intervention type:
Drug
Intervention name:
UCPVax
Description:
UCPVax vaccine (combined with Montanide ISA51 as adjuvant) at 0.5 mg subcutaneously
Arm group label:
Experimental Arm (Arm A)
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)
Criteria for eligibility:
Criteria:
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 RECIST v1.1 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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
CHU de Besançon
Address:
City:
Besançon
Country:
France
Status:
Recruiting
Contact:
Last name:
Christophe BORG, Pr
Facility:
Name:
Hôpital Henri Mondor
Address:
City:
Créteil
Country:
France
Status:
Recruiting
Contact:
Last name:
Hélène REGNAULT, Dr
Facility:
Name:
Centre Georges François Leclerc
Address:
City:
Dijon
Country:
France
Status:
Recruiting
Contact:
Last name:
François GHIRINGHELLI, Pr
Facility:
Name:
Hôpital Nord Franche-Comté
Address:
City:
Montbéliard
Country:
France
Status:
Recruiting
Contact:
Last name:
Serge FRATTE, Dr
Facility:
Name:
CHU de Montpellier
Address:
City:
Montpellier
Country:
France
Status:
Recruiting
Contact:
Last name:
Eric ASSENAT, Pr
Facility:
Name:
Centre Hospitalier Paris St Joseph
Address:
City:
Paris
Country:
France
Status:
Not yet recruiting
Contact:
Last name:
Eric RAYMOND, Pr
Facility:
Name:
Groupe Hospitalier Paris Salpetrière
Address:
City:
Paris
Country:
France
Status:
Not yet recruiting
Contact:
Last name:
Manon ALLAIRE, Dr
Facility:
Name:
Hôpital BEAUJON
Address:
City:
Paris
Country:
France
Status:
Recruiting
Contact:
Last name:
Mohamed BOUATTOUR, Dr
Facility:
Name:
Institut Mutualiste Montsouris
Address:
City:
Paris
Country:
France
Status:
Recruiting
Contact:
Last name:
Emilie SOULARUE, Dr
Facility:
Name:
Hôpital Paul Brousse
Address:
City:
Villejuif
Country:
France
Status:
Recruiting
Contact:
Last name:
Pascal HAMMEL, Dr
Contact backup:
Last name:
Olivier ROSMORDUC, Dr
Start date:
September 27, 2022
Completion date:
September 30, 2027
Lead sponsor:
Agency:
Centre Hospitalier Universitaire de Besancon
Agency class:
Other
Collaborator:
Agency:
GERCOR - Multidisciplinary Oncology Cooperative Group
Agency class:
Other
Collaborator:
Agency:
PRODIGE
Agency class:
Other
Source:
Centre Hospitalier Universitaire de Besancon
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05528952
