Clinical trial NCT05528952: Evaluation of the Interest to Combine a CD4 Th1-inducer Cancer Vaccine Derived from Telomerase and Atezolizumab Plus Bevacizumab in Unresectable Hepatocellular Carcinoma
Official title: 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)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Hepatocellular Carcinoma
Keywords: CD4 Th1-inducer cancer vaccine
Lead sponsor: Centre Hospitalier Universitaire de Besancon
Sponsor class: OTHER
Collaborators: name: GERCOR - Multidisciplinary Oncology Cooperative Group
name: PRODIGE
First posted: 2022-09-06
Enrollment: 105
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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)


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 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

Primary outcomes:
measure: objective response rate (ORR)
timeFrame: at 6 months
Secondary outcomes:
measure: overall survival (OS)
timeFrame: through study completion, an average of 2 years
measure: progression-free-survival (PFS)
timeFrame: through study completion, an average of 2 years
measure: disease control rate (DCR)
timeFrame: at 6 months
Other outcomes:
Locations:
city: Besançon
country: France
facility: CHU de Besançon
city: Chalon-sur-Saône
country: France
facility: CH William Morey
city: Créteil
country: France
facility: Hôpital Henri Mondor
city: Dijon
country: France
facility: Centre Georges François Leclerc
city: Montbéliard
country: France
facility: Hôpital Nord Franche-Comté
city: Montpellier
country: France
facility: CHU de Montpellier
city: Mulhouse
country: France
facility: CH de Mulhouse
city: Paris
country: France
facility: Centre Hospitalier Paris St Joseph
city: Paris
country: France
facility: Groupe Hospitalier Paris Salpetrière
city: Paris
country: France
facility: Hôpital BEAUJON
city: Paris
country: France
facility: Institut Mutualiste Montsouris
city: Villejuif
country: France
facility: Hôpital Paul Brousse
Study officials:
References: