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NCT04696055 · ClinicalTrials.gov registry record · Phase 2
Regorafenib Plus Pembrolizumab in Patients With Advanced or Spreading Liver Cancer Who Have Been Previously Treated With PD-1/PD-L1 Immune Checkpoint Inhibitors
A Phase 2 study, sponsored by Bayer.
- Completed
- Registry status
- Phase 2
- Development phase
- 95
- Enrollment target
NCT04696055 is a Phase 2 study that has completed, run by Bayer. The registered enrollment target is 95 participants.
The verdict
NCT04696055, a Phase 2 study, has completed, sponsored by Bayer.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 95 participants
- Enrollment target
Study Summary
Researchers are looking for a better way to treat people diagnosed with 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.
Interventions
- DRUG Pembrolizumab
- DRUG Regorafenib (Stivarga, BAY73-4506)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 95 participants |
| Start Date | 2021-02-03 |
| Est. Completion | 2024-04-23 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04696055
The ClinicalTrials.gov registry entry for NCT04696055 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 95 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Bayer, which has 591 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Pembrolizumab is the first listed.
NCT04696055 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04696055 about?
NCT04696055 is a clinical study titled "Regorafenib Plus Pembrolizumab in Patients With Advanced or Spreading Liver Cancer Who Have Been Previously Treated With PD-1/PD-L1 Immune Checkpoint Inhibitors". Researchers are looking for a better way to treat people diagnosed with 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...
What is the current status of trial NCT04696055?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 95 participants. The study started on 2021-02-03. Estimated completion is 2024-04-23.
What interventions are being tested in trial NCT04696055?
The interventions under investigation include: Pembrolizumab (DRUG), Regorafenib (Stivarga, BAY73-4506) (DRUG).
Who is sponsoring clinical trial NCT04696055?
This trial is sponsored by Bayer, which has 591 total clinical trials registered on ClinicalTrials.gov.
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