Ignite Creation Date:
2024-05-06 @ 3:38 PM
Last Modification Date:
2024-10-26 @ 1:53 PM
Study NCT ID:
NCT04704154
Status:
COMPLETED
Last Update Posted:
2024-02-29
First Post:
2021-01-08
Brief Title:
A Trial to Learn Whether Regorafenib in Combination With Nivolumab Can Improve Tumor Responses and How Safe it is for Participants With Solid Tumors
Sponsor:
Bayer
Organization:
Bayer
Study Overview
Official Title:
A Multi-indication Single-treatment Arm Open-label Phase 2 Study of Regorafenib and Nivolumab in Combination in Patients With Recurrent or Metastatic Solid Tumors
Status:
COMPLETED
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
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 with solid tumors 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 want to learn about regorafenib taken together with nivolumab in a small number of participants with different types of tumors These include tumors in the head and neck the esophagus the pancreas the brain and the biliary tract The biliary tract includes gall bladder and bile ducts
The trial will include about 200 participants who are at least 18 years old All of the participants will take 90 mg of regorafenib as a tablet by mouth The dose of regorafenib can be adjusted up to 120 mg or down to 60 mg by the doctor based on how well a participant tolerates treatment All of the participants will receive 480 milligrams mg of nivolumab through a needle put into a vein IV infusion
The participants will take treatments in 4-week periods called cycles They will take regorafenib once a day for 3 weeks then stop for 1 week In each cycle the participants will receive nivolumab one time These 4-week cycles will be repeated throughout the trial The participants can take nivolumab and regorafenib until their cancer gets worse until they have medical problems or until they leave the trial The longest nivolumab can be given is up to 2 years
During the trial the doctors will take pictures of the participants tumors using CT or MRI and will take blood and urine samples The doctors will also do physical examinations and check the participants heart health using an electrocardiogram ECG They will ask questions about how the participants are feeling and if they have any medical problems
In this trial the researchers want to learn about regorafenib taken together with nivolumab in a small number of participants with different types of tumors These include tumors in the head and neck the esophagus the pancreas the brain and the biliary tract The biliary tract includes gall bladder and bile ducts
The trial will include about 200 participants who are at least 18 years old All of the participants will take 90 mg of regorafenib as a tablet by mouth The dose of regorafenib can be adjusted up to 120 mg or down to 60 mg by the doctor based on how well a participant tolerates treatment All of the participants will receive 480 milligrams mg of nivolumab through a needle put into a vein IV infusion
The participants will take treatments in 4-week periods called cycles They will take regorafenib once a day for 3 weeks then stop for 1 week In each cycle the participants will receive nivolumab one time These 4-week cycles will be repeated throughout the trial The participants can take nivolumab and regorafenib until their cancer gets worse until they have medical problems or until they leave the trial The longest nivolumab can be given is up to 2 years
During the trial the doctors will take pictures of the participants tumors using CT or MRI and will take blood and urine samples The doctors will also do physical examinations and check the participants heart health using an electrocardiogram ECG They will ask questions about how the participants are feeling and if they have any medical problems
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 |
|---|---|---|---|
| 2020-003359-13 | EUDRACT_NUMBER | None | None |