Immunotherapy for advanced liver cancer

Phase II/III Randomized, Controlled Clinical Study of AlloStim(R) vs Physician's Choice in Asian Subjects With Advanced Hepatocellular Carcinoma

This study is testing a new immunotherapy called AlloStim® to see if it helps Asian adults with advanced liver cancer feel better compared to standard treatments.

Quick facts

• Phase: PHASE2; PHASE3
• Study type: Interventional
• Enrollment: 150 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: Mirror Biologics, Inc. (industry)
• Drugs / interventions: nivolumab, duvalumab, tremelimumab, ramucircumab, levantinib, cabozantinib, radiation, Lenvatinib, immunotherapy, chemotherapy
• Locations: 8 sites (Johor Bahru, Johor and 7 other locations)
• Trial ID: NCT05033522 on ClinicalTrials.gov

What this trial studies

This clinical trial is a randomized, controlled multi-site trial conducted in Thailand and Malaysia, focusing on Asian adults aged 18 and older with advanced hepatocellular carcinoma (HCC) that is not eligible for locoregional treatments. Participants will be randomized in a 2:1 ratio to receive AlloStim® immunotherapy or a physician's choice of standard treatments, including sorafenib, lenvatinib, or FOLFOX4. The study aims to evaluate the efficacy and safety of AlloStim® compared to existing treatment options for patients with BCLC stage C HCC.

Who should consider this trial

Good fit: Ideal candidates for this study are Asian adults aged 18 and older with histologically confirmed advanced HCC (BCLC stage C) and Child-Pugh class A or B liver function.

Not a fit: Patients with prior treatments for BCLC stage C disease or those with Child-Pugh class C liver function will not benefit from this study.

Why it matters

Potential benefit: If successful, this trial could provide a new immunotherapy option for patients with advanced liver cancer, potentially improving survival rates.

How similar studies have performed: Other studies have shown success with immunotherapy approaches in liver cancer, but this specific trial is exploring a novel treatment option in a specific population.

Eligibility criteria

Inclusion Criteria:

1. Males and females who are at least 18 years of age at time of enrollment
2. Histologically or cytologically documented advanced HCC (BCLC stage C) disease at diagnosis.
3. No prior treatment for BCLC class C disease.
4. Child-Pugh Class A or subset of Child-Pugh Class B
5. Performance status: ECOG \< 2 with no deterioration over the previous 2 weeks
6. With or without positive HBV and/or HCV
7. With or without extrahepatic disease and with or without macrovascular invasion
8. Measurable enhancing disease in liver with at least one target lesion evaluable by mRECIST
9. Adequate hematological, liver and renal function as assessed by the following:

   * Hemoglobin \> 10.0 g/dl
   * Platelet count \> 75,000/μl
   * ALT and AST \< 5.0 x ULN
   * Serum creatinine \< 1.5
10. Women of child-bearing potential: negative pregnancy test
11. Patients of child producing potential: usage of contraception or avoidance of pregnancy measures while enrolled on study
12. Ability to understand the study, its inherent risks, side effects and potential benefits and ability to give written informed consent to participate

Exclusion Criteria:

1. Any prior cancer diagnosis (other than cured basal cell carcinoma, head and neck carcinoma in-situ, or superficial Ta, Tis, T1 bladder cancer) or concurrent cancer histologically different than HCC (e.g., cholangiocarcinoma).
2. Child-Pugh liver function combined score \>9 (Class C or Class D)
3. Moderate uncontrolled or severe ascites (+3 on Child-Pugh calculator)
4. Clinical symptoms of hepatic decompensation or presence of hepatic encephalopathy
5. Severe stomach/esophageal varices requiring interventional treatment.
6. Unable to tolerate radiological contrast dye
7. Any prior experimental, approved or off-label treatment for HCC (including levantinib, nivolumab, duvalumab, tremelimumab, brivananib, cabozantinib or ramucircumab) or any approved or experimental procedures such as surgery, radiation or ablation.
8. Enrollment in any previous clinical trial for HCC
9. Any history of autoimmune disorder (type I, insulin-dependent diabetes allowed)
10. History of COPD or oxygen saturation \<92% at room air
11. Any clinical condition requiring systemic steroids (inhaled steroids allowed) or any current immunosuppressive therapy or anti-epileptic drug therapy.
12. Known history of HIV infection
13. Clinically significant gastrointestinal bleeding within 30 days prior to study entry
14. History of cardiac disease: congestive heart failure \> NYHA class 2; cardiac arrhythmias requiring anti-arrhythmic therapy (beta blockers or Digoxin are permitted)
15. Uncontrolled hypertension (SBP \>150 or DBP\>90).
16. Active clinically serious infections (\> grade 2 CTCAE version 5.0)
17. History of organ transplant or tissue allograft
18. Uncontrolled concurrent serious medical or psychiatric illness
19. Clinically apparent central nervous system metastases or carcinomatous meningitis
20. History of drug abuse or current alcohol abuse
21. History of blood transfusion reactions
22. Pregnant or lactating women

Where this trial is running

Johor Bahru, Johor and 7 other locations

• Sultan Ismail Hospital — Johor Bahru, Johor, Malaysia (RECRUITING)
• Sultanah Bahiyah Hospital — Alor Setar, Kedah, Malaysia (RECRUITING)
• Columbia Asia Bukit Rimau — Shah Alam, Selangor Darul Ehsan, Malaysia (RECRUITING)
• Siriraj Hospital — Bangkok Noi, Bangkok, Thailand (RECRUITING)
• Prince of Songkla University (Songklanagarind Hospital) — Hat Yai, Songkhla, Thailand (RECRUITING)
• Naresuan University Hospital — Phitsanulok, Tha Pho, Thailand (RECRUITING)
• Chiangmai University — Chiangmai, Thailand (RECRUITING)
• Songklanagarind Hospital — Khon Kaen, Thailand (RECRUITING)

Study contacts

• Study coordinator: Preechanoot Aimruen, CRA

Conditions: Hepatocellular Carcinoma, liver cancer, immunotherapy, Thailand, Malaysia