Ignite Creation Date:
2024-05-06 @ 1:26 PM
Last Modification Date:
2024-10-26 @ 1:14 PM
Study NCT ID:
NCT04028245
Status:
RECRUITING
Last Update Posted:
2024-07-09
First Post:
2019-07-18
Brief Title:
A Study of Combination Spartalizumab and Canakinumab in Patients With Localized Clear Cell Renal Cell Carcinoma
Sponsor:
Columbia University
Organization:
Columbia University
Study Overview
Official Title:
A Pilot Study of Neoadjuvant Combination Spartalizumab and Canakinumab Prior to Radical Nephrectomy in Patients With Localized Clear Cell Renal Cell Carcinoma SPARC-1 Trial
Status:
RECRUITING
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:
SPARC-1
Brief Summary:
Primary Objective
To confirm the safety and feasibility of canakinumab and spartalizumab PDR-001 administered using a standard dose schedule in the neo-adjuvant setting in renal cell carcinoma
Secondary Objectives
To assess the immune response to combination canakinumab and spartalizumab
To assess anti-tumor activity as measured by pathologic downstaging
To confirm the safety and feasibility of canakinumab and spartalizumab PDR-001 administered using a standard dose schedule in the neo-adjuvant setting in renal cell carcinoma
Secondary Objectives
To assess the immune response to combination canakinumab and spartalizumab
To assess anti-tumor activity as measured by pathologic downstaging
Detailed Description:
Patients with localized and non-metastatic Renal Cell Carcinoma RCC represent an at-need population who would benefit from immunotherapy earlier in their disease course with a programmed cell death protein 1PD-1 therapy combined with a second immunotherapy agent A logical next step is to pursue the combination of an anti- programmed cell death protein 1PD1 therapy with cytotoxic T-lymphocyte associated protein 4 CTLA-4 blockade extrapolating from recent successes in the metastatic setting The primary concern with previous approaches and studies is that CTLA-4 based therapy is associated with increased risk of autoimmune side effects which potentially could delay a curative surgery Clearly the neoadjuvant setting in RCC represents an ideal space to evaluate novel IO combination strategies aside from CTLA-4 blockade
This study intends to confirm the safety and feasibility of canakinumab and spartalizumab PDR-001 administered using a standard dose schedule in the neo-adjuvant setting in renal cell carcinoma This is a single-center single arm open-label pilot study evaluating the feasibility safety anti-tumor effect and immunogenicity of neoadjuvant canakinumab and spartalizumab given prior to radical nephrectomy in patients with localized renal cell carcinoma Patients will be recruited from the outpatient Urology clinic
Eligible patients will receive canakinumab at a dose of 300 mg Q4weeks and spartalizumab at 400 mg Q4weeks IV Approximately 14 days after the last dose of canakinumab and spartalizumab patients with proceed to radical nephrectomy and nephrectomy tissue will be examined for the secondary endpoints Follow-up evaluation for adverse events will occur 30 days and 90 days after surgery Patients will then be followed by their urologists and oncologist according to standard institutional practices but will require repeat labs every 3 months along with standard of care surveillance imaging
This study intends to confirm the safety and feasibility of canakinumab and spartalizumab PDR-001 administered using a standard dose schedule in the neo-adjuvant setting in renal cell carcinoma This is a single-center single arm open-label pilot study evaluating the feasibility safety anti-tumor effect and immunogenicity of neoadjuvant canakinumab and spartalizumab given prior to radical nephrectomy in patients with localized renal cell carcinoma Patients will be recruited from the outpatient Urology clinic
Eligible patients will receive canakinumab at a dose of 300 mg Q4weeks and spartalizumab at 400 mg Q4weeks IV Approximately 14 days after the last dose of canakinumab and spartalizumab patients with proceed to radical nephrectomy and nephrectomy tissue will be examined for the secondary endpoints Follow-up evaluation for adverse events will occur 30 days and 90 days after surgery Patients will then be followed by their urologists and oncologist according to standard institutional practices but will require repeat labs every 3 months along with standard of care surveillance imaging
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