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

NCT04028245 · Status: COMPLETED · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 17

Last updated 2026-04-15

No results posted yet for this study

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

Conditions

  • Carcinoma, Renal Cell

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

Sponsors & Collaborators

Principal Investigators

  • Karie D. Runcie, MD · Columbia University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-08-15
Primary Completion
2025-03-14
Completion
2026-03-05
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04028245 on ClinicalTrials.gov