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

Hepatocellular Carcinoma Clinical Trial

— TERTIO  

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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05528952
• Other study ID #: 2022/680
• Status: Recruiting
• Phase: Phase 2
• Start date: September 27, 2022
• Est. completion date: September 30, 2027

Study information

• Verified date: November 2023
• Source: Centre Hospitalier Universitaire de Besancon
• Contact: Borg Christophe, Pr
• Phone: +33 3 81 47 99 99
• Email: xtoph.borg[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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)

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 105
• Est. completion date: September 30, 2027
• Est. primary completion date: April 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular
• Hepatocellular Carcinoma

Intervention

Drug:
• Atezolizumab
1200 mg IV every 3 weeks until disease progression or unacceptable toxicity
• Bevacizumab
15 mg/kg IV every 3 weeks until disease progression or unacceptable toxicity
• UCPVax
UCPVax vaccine (combined with Montanide ISA51 as adjuvant) at 0.5 mg subcutaneously

Locations

Country	Name	City	State
France	CHU de Besançon	Besançon
France	Hôpital Henri Mondor	Créteil
France	Centre Georges François Leclerc	Dijon
France	Hôpital Nord Franche-Comté	Montbéliard
France	CHU de Montpellier	Montpellier
France	Centre Hospitalier Paris St Joseph	Paris
France	Groupe Hospitalier Paris Salpetrière	Paris
France	Hôpital BEAUJON	Paris
France	Institut Mutualiste Montsouris	Paris
France	Hôpital Paul Brousse	Villejuif

Sponsors (3)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Besancon	GERCOR - Multidisciplinary Oncology Cooperative Group, PRODIGE

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	objective response rate (ORR)	addition of complete response (CR) and partial response (PR) rates, evaluated by RECIST criteria v1.1	at 6 months
Secondary	overall survival (OS)	delay from the date of randomization to death from any cause.	through study completion, an average of 2 years
Secondary	progression-free-survival (PFS)	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
Secondary	disease control rate (DCR)	addition of complete response (CR), partial response (PR), and stable disease (SD) rates, evaluated by RECIST criteria v1.1 and imRECIST	at 6 months