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ACTIVE NOT RECRUITING
NCT04028245
EARLY_PHASE1

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

Sponsor: Columbia University

View on ClinicalTrials.gov

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

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)

Key Details

Gender

All

Age Range

18 Years - 99 Years

Study Type

INTERVENTIONAL

Enrollment

17

Start Date

2019-08-15

Completion Date

2026-03

Last Updated

2025-08-07

Healthy Volunteers

No

Interventions

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

Locations (1)

Columbia University Irving Medical Center

New York, New York, United States