NCT05199285

A Phase II Study of Nivolumab + Ipilimumab in Advanced HCC Patients Who Have Progressed on First Line Atezolizumab + Bevacizumab

Terminated Phase 2 Last updated 3 October 2025

What this trial tests

Phase 2 trial testing Ipilimumab in BCLC Stage B Hepatocellular Carcinoma in 15 participants. Terminated before completion.

Timeline

19 January 2023

Primary endpoint
4 September 2025

4 September 2025

Quick facts

Lead sponsor	Academic and Community Cancer Research United
Phase	Phase 2
Status	Terminated
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	15
Start date	19 January 2023
Primary completion	4 September 2025
Estimated completion	4 September 2025
Sites	5 locations across United States

Drugs / interventions tested

• Ipilimumab — full drug profile →
• Nivolumab (nivolumab) — full drug profile →

Conditions studied

• BCLC Stage B Hepatocellular Carcinoma — all drugs for BCLC Stage B Hepatocellular Carcinoma →
• BCLC Stage C Hepatocellular Carcinoma — all drugs for BCLC Stage C Hepatocellular Carcinoma →
• Locally Advanced Hepatocellular Carcinoma — all drugs for Locally Advanced Hepatocellular Carcinoma →
• Metastatic Hepatocellular Carcinoma — all drugs for Metastatic Hepatocellular Carcinoma →

Sponsor

Academic and Community Cancer Research United — full company profile →

Who can join

18 and older, any sex, with BCLC Stage B Hepatocellular Carcinoma or BCLC Stage C Hepatocellular Carcinoma. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This phase II trial tests whether nivolumab and ipilimumab works to shrink tumors in patients with liver cancer that has spread to nearby tissue or lymph nodes (locally advanced), has spread to other places in the body (metastatic), or cannot be removed by surgery (unresectable). Immunotherapy with monoclonal antibodies, such as nivolumab and ipilimumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Nivolumab and ipilimumab may be effective in killing tumor cells in patients with liver cancer.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. PD-1/PD-L1 checkpoint inhibitors in advanced hepatocellular carcinoma immunotherapy.
   Li Q, Han J, Yang Y, Chen Y. · · 2022 · cited 173× · PMID 36601120 · DOI 10.3389/fimmu.2022.1070961
2. Immunotherapy in liver cancer: overcoming the tolerogenic liver microenvironment.
   Liu Y, Yang H, Li T, Zhang N. · · 2024 · cited 23× · PMID 39295859 · DOI 10.3389/fimmu.2024.1460282
3. Immune-Based Combination Therapies for Advanced Hepatocellular Carcinoma.
   Carloni R, Sabbioni S, Rizzo A, Ricci AD, et al · · 2023 · cited 16× · PMID 37701562 · DOI 10.2147/jhc.s390963
4. Advancements in Immunotherapeutic Treatments for Hepatocellular Carcinoma: Potential of Combination Therapies.
   Zarlashat Y, Mushtaq H, Pham L, Abbas W, et al · · 2024 · cited 12× · PMID 38999940 · DOI 10.3390/ijms25136830
5. The Tumor Microenvironment of Hepatocellular Carcinoma: Untying an Intricate Immunological Network.
   Volponi C, Gazzillo A, Bonavita E. · · 2022 · cited 10× · PMID 36551635 · DOI 10.3390/cancers14246151
6. Second-Line Treatment after Failure of Immune Checkpoint Inhibitors in Hepatocellular Carcinoma: Tyrosine Kinase Inhibitor, Retrial of Immunotherapy, or Locoregional Therapy?
   Hwang SY, Lee SL, Liu H, Lee SS. · · 2024 · cited 7× · PMID 38894810 · DOI 10.1159/000534303
7. Second-line therapies in advanced hepatocellular carcinoma following first-line atezolizumab and bevacizumab: multicenter single institution cohort experience.
   Marell P, Kournoutas I, Gile J, Peersen A, et al · · 2025 · cited 5× · PMID 39674576 · DOI 10.1093/oncolo/oyae342
8. Insights in Molecular Therapies for Hepatocellular Carcinoma.
   Heumann P, Albert A, Gülow K, Tümen D, et al · · 2024 · cited 5× · PMID 38791911 · DOI 10.3390/cancers16101831