Ignite Creation Date:
2025-12-25 @ 4:58 AM
Ignite Modification Date:
2025-12-26 @ 3:58 AM
Study NCT ID:
NCT06940518
Status:
RECRUITING
Last Update Posted:
2025-08-17
First Post:
2025-04-15
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Phase II Trial of Ivonescimab in Previously Treated Patients With Advanced Clear Cell Renal Cell Carcinoma
Sponsor:
M.D. Anderson Cancer Center
Organization:
Study Overview
Official Title:
Phase II Trial of Ivonescimab in Previously Treated Patients With Advanced Clear Cell Renal Cell Carcinoma
Status:
RECRUITING
Status Verified Date:
2025-05
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:
To learn if ivonescimab can help to control previously treated, locally advanced or metastatic ccRCC.
Detailed Description:
Primary Objectives To determine the efficacy of objective response rate (ORR) and 24-week disease control rate (DCR), per RECIST 1.1, of ivonescimab monotherapy in participants with locally advanced or metastatic renal cell carcinoma with a clear cell component who had progression on at least one prior line of therapy.
Secondary Objectives To determine the safety profile of ivonescimab monotherapy in patients with locally advanced or metastatic renal cell carcinoma with a clear cell component who had progression on at least one prior line of therapy. To determine the overall survival (OS), progression free survival (PFS), duration of response (DOR), and adverse events with ivonescimab monotherapy in patients with locally advanced or metastatic renal cell carcinoma with a clear cell component who had progression on at least one prior line of therapy.
Secondary Objectives To determine the safety profile of ivonescimab monotherapy in patients with locally advanced or metastatic renal cell carcinoma with a clear cell component who had progression on at least one prior line of therapy. To determine the overall survival (OS), progression free survival (PFS), duration of response (DOR), and adverse events with ivonescimab monotherapy in patients with locally advanced or metastatic renal cell carcinoma with a clear cell component who had progression on at least one prior line of therapy.
Study Oversight
Has Oversight DMC:
True
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?:
True
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| NCI-2025-02811 | OTHER | NCI-CTRP Clinical Registry | View |