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

Part of paid clinical trials in New York, New York.

Sponsor
Columbia University
Study ID
NCT04028245
Phase
EARLY_PHASE1
Status
Completed

Conditions

  • Carcinoma, Renal Cell

Eligibility Criteria

Sex
ALL
Age
18 Years - 99 Years
Healthy Volunteers
Not accepted

Interventions

  • Spartalizumab — DRUG
    Spartalizumab at 400 mg weeks x 2 doses prior to radical nephrectomy Infusion
  • Canakinumab — DRUG
    Canakinumab 300 mg IV Q4 weeks x 2 doses prior to radical nephrectomy Infusion

Study Details

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

Key Dates

Start date
Aug 15, 2019
Status verified
Apr 2026
Primary completion
Mar 14, 2025
Completion
Mar 5, 2026

Study Design

Enrollment
17 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Spartalizumab and Canakinumab
    Subjects with renal cell carcinoma will receive study treatment Q4 weeks x 2 doses prior to radical nephrectomy.

Primary Outcome Measure

Percentage of subjects who proceed to radical nephrectomy [ Time Frame: 6 Weeks ]

Locations (1)

FacilityCityStateZIPSite coordinators
Columbia University Irving Medical CenterNew YorkNew York10032-

Find similar trials in New York, NY

By research site
Columbia University Irving Medical Center· New York, NY

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