Combining a cancer vaccine with immunotherapy for liver cancer treatment

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)

This study is testing a new cancer vaccine combined with immunotherapy to see if it can help people with advanced liver cancer who haven't had treatment before.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 105 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Centre Hospitalier Universitaire de Besancon (Academic / other)
• Drugs / interventions: immunotherapy, radiation, atezolizumab, bevacizumab
• Locations: 14 sites (Besançon and 13 other locations)
• Trial ID: NCT05528952 on ClinicalTrials.gov

What this trial studies

The TERTIO trial aims to evaluate the effectiveness of a novel treatment combining a CD4 Th1-inducer cancer vaccine derived from telomerase (UCPVax) with the immunotherapy agents atezolizumab and bevacizumab in patients with unresectable hepatocellular carcinoma (HCC). This phase II trial will assess the objective response rate at 6 months across 10 centers, involving a total of 105 patients. The study focuses on patients who have not previously received systemic anti-cancer treatment and have measurable disease according to established guidelines.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 18 and older with histologically confirmed unresectable hepatocellular carcinoma who have not received prior systemic anti-cancer treatment.

Not a fit: Patients with resectable liver cancer or those who have previously undergone systemic anti-cancer treatment may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with advanced liver cancer who currently have limited treatment choices.

How similar studies have performed: Other studies combining immunotherapy with cancer vaccines have shown promising results, suggesting potential for success in this novel approach.

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

Where this trial is running

Besançon and 13 other locations

• 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)

Study contacts

• Study coordinator: Borg Christophe, Pr

Conditions Hepatocellular Carcinoma; CD4 Th1-inducer cancer vaccine