Ignite Creation Date:
2024-05-06 @ 1:23 PM
Last Modification Date:
2024-10-26 @ 1:13 PM
Study NCT ID:
NCT04004442
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-02-14
First Post:
2019-06-28
Brief Title:
Avelumab in Combination With AVB-S6-500 in Patients With Advanced Urothelial Carcinoma
Sponsor:
University of Oklahoma
Organization:
University of Oklahoma
Study Overview
Official Title:
Phase I Study of Avelumab in Combination With AXL Inhibitor AVB-S6-500 in Patients With Advanced Urothelial Carcinoma
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-02
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:
COAXIN
Brief Summary:
The purpose of this research study is to test the safety of avelumab and AVB-S6-500 and see what effects good and bad this combination treatment has on patients with advanced urothelial carcinoma
Detailed Description:
Patients will have tests and exams to see if they are eligible for the clinical trial If found eligible the patient will receive treatment with avelumab and AVB-S6-500 by vein once every two weeks
This study has two parts in order to determine the maximum tolerated dose of AVB-S6-500 If the patient is enrolled on the first dose level the patient will be treated at a higher dose every two weeks with AVB-S6-500 If the patient is enrolled on the second dose level the patient will be receive AVB-S6-500 only once a week at a lower dose The patient would continue to receive avelumab twice weekly at the same dose
Patients will receive the study treatment as long as there is evidence that the tumor is not growing or spreading and they are not having any unacceptable bad side effects
Patients will be monitored during treatment with tests and exams and after treatment completion for up to one year
This study has two parts in order to determine the maximum tolerated dose of AVB-S6-500 If the patient is enrolled on the first dose level the patient will be treated at a higher dose every two weeks with AVB-S6-500 If the patient is enrolled on the second dose level the patient will be receive AVB-S6-500 only once a week at a lower dose The patient would continue to receive avelumab twice weekly at the same dose
Patients will receive the study treatment as long as there is evidence that the tumor is not growing or spreading and they are not having any unacceptable bad side effects
Patients will be monitored during treatment with tests and exams and after treatment completion for up to one year
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