Ignite Creation Date:
2024-05-06 @ 3:36 PM
Last Modification Date:
2024-10-26 @ 1:53 PM
Study NCT ID:
NCT04696055
Status:
COMPLETED
Last Update Posted:
2024-05-01
First Post:
2021-01-04
Brief Title:
Regorafenib Plus Pembrolizumab in Patients With Advanced or Spreading Liver Cancer Who Have Been Previously Treated With PD-1PD-L1 Immune Checkpoint Inhibitors
Sponsor:
Bayer
Organization:
Bayer
Study Overview
Official Title:
An Open-Label Study of Regorafenib in Combination With Pembrolizumab in Patients With Advanced or Metastatic Hepatocellular Carcinoma HCC After PD1PD-L1 Immune Checkpoint Inhibitors
Status:
COMPLETED
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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-1PD-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
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-1PD-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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2020-003555-16 | EUDRACT_NUMBER | Merck | None |
| MK-3475-B70 | OTHER | None | None |
| Keynote B70 | OTHER | None | None |