NCT04028245

A Study of Combination Spartalizumab and Canakinumab in Patients With Localized Clear Cell Renal Cell Carcinoma

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: Completed
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 17 (actual)
• Sponsor: Columbia University · Academic / Other
• Sex: All
• Age: 18 Years – 99 Years
• Healthy volunteers: Not accepted

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

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 1(PD-1) therapy combined with a second immunotherapy agent. A logical next step is to pursue the combination of an anti- programmed cell death protein 1(PD1) 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 I/O 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.

Conditions

• Carcinoma, Renal Cell

Interventions

Type	Name	Description
DRUG	Spartalizumab	Spartalizumab at 400 mg weeks x 2 doses prior to radical nephrectomy Infusion
DRUG	Canakinumab	Canakinumab 300 mg IV Q4 weeks x 2 doses prior to radical nephrectomy Infusion

Timeline

• Start date: 2019-08-15
• Primary completion: 2025-03-14
• Completion: 2026-03-05
• First posted: 2019-07-22
• Last updated: 2026-04-15

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study