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RegorafenibCombo w/Pembrolizumab in Pts w/Adv orMet Hepatocellular Car after PD-1/PD-L1

Farshid Dayyani


A Study On:

  • Liver

Status:

  • Open

Eligibility

Adult

Interested in joining this trial?

Official Title

An Open-Label Study of Regorafenib in Combination with Pembrolizumab in Patients with Advanced or Metastatic Hepatocellular Carcinoma (HCC) after PD-1/PD-L1 Immune Checkpoint Inhibitors

Details

Researchers are looking for a better way to treat people suffering from liver cancer which may have spread to nearby tissue and is unlikely to be cured or controlled with treatment (advanced metastatic hepatocellular carcinoma, HCC). Before a treatment can be approved for people to take, researchers do clinical trials to better understand its safety and how it works.

In this trial, the researchers will learn more about the trial treatment, regorafenib, in a small number of participants. They will study the results when the trial treatment is taken with another cancer treatment called pembrolizumab.

There will be 2 parts to this trial. The part 1 (pilot phase) will include about 52 men and women. The part 2 (expansion phase) will include about 67 men and women. All of the participants will have HCC and will be aged 18 years or older. All of the participants will have tried other treatments that did not help their HCC. These other treatments (PD-1/PD-L1 Immune Checkpoint Inhibitors) are designed to work by stopping the activity of certain proteins in the immune system thought to play a role in HCC.

During both parts of the trial, the participants will take regorafenib and receive pembrolizumab. In the pilot phase, there will be 2 groups of participants. The group that each participant joins will be based on the treatment they already received for their HCC. The researchers will review the results in each group to learn if regorafenib and pembrolizumab are helping one group of participants more than others. Outcome of this review will determine the population to be treated in the expansion phase.


Eligibility

You can join if...

Inclusion Criteria:

  • Patients must have confirmed, advanced hepatocellular cancer (HCC).
  • Patients must have progressed after only one prior line of immunotherapy with an anti-PD-1/PD-L1 mAb (monoclonal antibody).

Exclusion Criteria:

  • Patients must not be pregnant or breastfeeding, or expecting to conceive children.
  • Patients must be able to swallow and retain oral medication.
  • Patients must not have had major surgical procedure or significant traumatic injury within 28 days before start of study medications.

Get in touch with our study team