Ignite Creation Date:
2024-05-06 @ 8:11 PM
Last Modification Date:
2024-10-26 @ 3:22 PM
Study NCT ID:
NCT06284564
Status:
RECRUITING
Last Update Posted:
2024-06-27
First Post:
2024-02-21
Brief Title:
A Phase II Study Bolstering Outcomes by Optimizing Immunotherapy Strategies With Evolocumab and Nivolumab in Patients With Metastatic Renal Cell Carcinoma BOOST-RCC
Sponsor:
MD Anderson Cancer Center
Organization:
MD Anderson Cancer Center
Study Overview
Official Title:
A Phase II Study Bolstering Outcomes by Optimizing Immunotherapy Strategies With Evolocumab and Nivolumab in Patients With Metastatic Renal Cell Carcinoma BOOST-RCC
Status:
RECRUITING
Status Verified Date:
2024-08
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 evolocumab and nivolumab can control metastatic and refractory renal cell carcinoma The safety of this drug combination will also be studied
Detailed Description:
Primary Objectives
- To determine the objective response rate Partial Response PR and Complete Response CR based on Response Evaluation Criteria in Solid Tumors RECIST v11 criteria and immune Response Evaluation Criteria in Solid Tumors iRECIST criteria of evolocumab and nivolumab in patients with metastatic renal cell carcinoma mRCC refractory to immunotherapy andor Vascular endothelial growth factor VEGF blockade
To confirm safety of evolocumab and nivolumab in participants with metastatic renal cell carcinoma mRCC refractory to immunotherapy andor Vascular endothelial growth factor VEGF blockade Detail the primary protocol objectives
Secondary Objectives
To describe the adverse events associated with evolocumab and administered with nivolumab
To determine the disease control rate Stable Disease SDPRCR based on RECIST 11 and iRECIST criteria
To determine duration of response in patients who achieve response
To determine progression free survival based on RECIST 11 criteria and iRECIST criteria
To determine 1-year survival rates and overall survival
Exploratory Objectives
To evaluate CD3 and CD8 T-cell infiltration and MHC-1 expression of paired tumor biopsies before and after treatment
To evaluate plasma low-density lipoproteins LDL cholesterol levels and circulating Proprotein convertase subtilisinkexin type 9 PSCK9 levels at baseline and on treatment
To evaluate circulating lymphoid and myeloid cell subsets and changes on treatment
To evaluate circulating tumor cells and changes on treatment
- To determine the objective response rate Partial Response PR and Complete Response CR based on Response Evaluation Criteria in Solid Tumors RECIST v11 criteria and immune Response Evaluation Criteria in Solid Tumors iRECIST criteria of evolocumab and nivolumab in patients with metastatic renal cell carcinoma mRCC refractory to immunotherapy andor Vascular endothelial growth factor VEGF blockade
To confirm safety of evolocumab and nivolumab in participants with metastatic renal cell carcinoma mRCC refractory to immunotherapy andor Vascular endothelial growth factor VEGF blockade Detail the primary protocol objectives
Secondary Objectives
To describe the adverse events associated with evolocumab and administered with nivolumab
To determine the disease control rate Stable Disease SDPRCR based on RECIST 11 and iRECIST criteria
To determine duration of response in patients who achieve response
To determine progression free survival based on RECIST 11 criteria and iRECIST criteria
To determine 1-year survival rates and overall survival
Exploratory Objectives
To evaluate CD3 and CD8 T-cell infiltration and MHC-1 expression of paired tumor biopsies before and after treatment
To evaluate plasma low-density lipoproteins LDL cholesterol levels and circulating Proprotein convertase subtilisinkexin type 9 PSCK9 levels at baseline and on treatment
To evaluate circulating lymphoid and myeloid cell subsets and changes on treatment
To evaluate circulating tumor cells and changes on treatment
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?:
False
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-2024-03604 | OTHER | NCI-CTRP Clinical Registry | None |