Ignite Creation Date:
2025-12-25 @ 12:22 AM
Ignite Modification Date:
2026-01-01 @ 11:16 AM
Study NCT ID:
NCT06053658
Status:
RECRUITING
Last Update Posted:
2025-09-05
First Post:
2023-09-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Phase 2 Study of Combination Tivozanib and Nivolumab in Advanced Non-Clear Cell Renal Cell Carcinoma
Sponsor:
M.D. Anderson Cancer Center
Organization:
Study Overview
Official Title:
Phase 2 Study of Combination Tivozanib and Nivolumab in Advanced Non-Clear Cell Renal Cell Carcinoma
Status:
RECRUITING
Status Verified Date:
2025-09
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 giving tivozanib in combination with nivolumab can help to control advanced nccRCC.
Detailed Description:
Primary Objectives
* To demonstrate efficacy of combination tivozanib and nivolumab in advanced non-clear cell renal cell carcinoma (nccRCC).
Secondary Objectives
* To assess the safety and toxicity of combination tivozanib and nivolumab.
* To estimate the duration of clinical efficacy
Exploratory Objectives
* To associate immune and tumor biomarkers with clinical efficacy
* To demonstrate efficacy of combination tivozanib and nivolumab in advanced non-clear cell renal cell carcinoma (nccRCC).
Secondary Objectives
* To assess the safety and toxicity of combination tivozanib and nivolumab.
* To estimate the duration of clinical efficacy
Exploratory Objectives
* To associate immune and tumor biomarkers with clinical efficacy
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?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| NCI-2023-07385 | OTHER | NCI-CTRP Clinical Trials Registry | View |