A Phase 2 Study of Livmoniplimab Plus Budigalimab in People With Liver Cancer


Full Title

A Phase 2, Randomized Study to Evaluate the Optimized Dose, Safety, and Efficacy of Livmoniplimab in Combination with Budigalimab for Locally Advanced or Metastatic Hepatocellular Carcinoma (HCC) Patients who Have Progressed After an Immune Checkpoint Inhibitor Containing Regimen in First-Line HCC - LIVIGNO-1


Researchers want to find the best dose of livmoniplimab and see how well it works with budigalimab to treat liver cancer. The people in this study have hepatocellular carcinoma that has spread and keeps growing after treatment.

Livmoniplimab blocks the release of TGF-beta, a protein that plays a role in cancer cell growth. Budigalimab blocks the protein PD-1, which usually acts as a brake on the immune system. Blocking TGF-beta and PD-1 may boost the power of your immune system to find and kill cancer cells. Both medications are given intravenously (by vein).

If you join this study, you will be randomly assigned to one of these treatments:

  • Standard treatment with lenvatinib or sorafenib, both of which are taken orally
  • Livmoniplimab (lower dose) plus budigalimab
  • Livmoniplimab (higher dose) plus budigalimab

Who Can Join

To join this study, there are a few conditions. You must:

  • Have hepatocellular carcinoma that has spread and keeps growing after treatment.
  • Have recovered from the serious side effects of prior treatments before getting the study therapy.
  • Be well enough to walk and take care of yourself. You must be able to do activities such as office work or light housework.
  • Be age 18 or older.


For more information or to see if you can join this study, please call Dr. Danny Khalil’s office at 646-888-4384.




Phase II (phase 2)

Disease Status

Relapsed or Refractory


ClinicalTrials.gov ID