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

NCT04028245 | Completed Early Phase 1 DMC FDA Drug

• 1 other identifier: AAAS2814
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 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

Conditions

Carcinoma, Renal Cell

Outcome Measures

Primary Outcomes (1)

• Percentage of subjects who proceed to radical nephrectomy

  Feasibility of spartalizumab and canakinumab will be met if \> 85% of patients proceed to radical nephrectomy (12 of 14).

  6 Weeks

Secondary Outcomes (3)

• Quantification of cluster of differentiation 8 (CD8) T cell infiltration into the tumor / peritumoral area infiltrates

  6 Weeks

• Quantification of immune cell populations (PMN-MDSC) in the tumor/ peritumoral area

  6 Weeks

• Objective tumor response rate

  6 Weeks

Study Arms (1)

Spartalizumab and Canakinumab

EXPERIMENTAL

Subjects with renal cell carcinoma will receive study treatment Q4 weeks x 2 doses prior to radical nephrectomy.

Drug: Spartalizumab; Drug: Canakinumab

Interventions

Spartalizumab DRUG

Spartalizumab at 400 mg weeks x 2 doses prior to radical nephrectomy Infusion

Also known as: PDR-001

Spartalizumab and Canakinumab

Canakinumab DRUG

Canakinumab 300 mg IV Q4 weeks x 2 doses prior to radical nephrectomy Infusion

Also known as: ACZ885

Spartalizumab and Canakinumab

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Radiographically consistent with or histologically confirmed clear cell RCC or predominantly clear cell RCC
• Localized non-metastatic RCC T1b-T4NanyM0 or TanyN1M0)
• Schedule to undergo either partial or radical nephrectomy as part of the treatment plan
• Eastern Cooperative Oncology Group (ECOG) score of 0 or 1
• Age ≥ 18 years old at time of consent
• HIV-infected patients who are healthy and have a low risk of AIDS-related outcomes as defined by the following
• Cluster of differentiation 4 (CD4+) T cell counts ≥ 350 cells/microliter OR undetectable HIV viral load
• no history of AIDS-defining opportunistic infection in the last year
• Normal organ and marrow function as defined below:
• White blood cell count (WBC) \> 3.0 K/mm3
• Absolute neutrophil count (ANC) ≥ 1.5 K/mm3
• Platelets ≥ 100 K/mm3
• Hemoglobin (Hgb) ≥ 9 g/dL
• Serum total bilirubin: ≤ 1.5 x upper limit of normal (ULN)
• Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 3.0 x ULN

You may not qualify if:

• Presence of distant metastases
• Presence of active, known or suspected autoimmune disease.
• No patients with documented, active infections, treated or untreated, may be included in this study
• Use of any live vaccines against infectious disease within 4 weeks of initiation ot study treatment.
• Prior therapy with experimental anti-tumor vaccines; any T cell co-stimulation or checkpoint pathways
• Prior treatment for RCC including surgery, radiation, thermoablation, or systemic therapy
• Surgery within 28 days of starting study treatment
• Prior treatment with any antibody or drug targeting T cell costimulation or immune checkpoint pathways (anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA-4, etc)
• Systemic chronic steroid therapy (≥ 10mg/day prednisone or equivalent) or any immunosuppressive therapy 7 days prior to planned date of first dose of study treatment. Note: Topical, inhaled, nasal and ophthalmic steroids are allowed
• Allogenic bone marrow or solid organ transplant
• History of severe hypersensitivity reactions to other monoclonal antibodies, which in the opinion of the investigator may pose an increased risk of serious infusion reaction
• History or current interstitial lung disease or non-infectious pneumonitis requiring the use of home oxygen
• History of severe hypersensitivity reaction to other monoclonal antibodies
• Current signs or symptoms of severe progressive or uncontrolled, hepatic, hematologic, gastrointestinal, endocrine, pulmonary, or cardiac disease other than directly related to RCC
• Positive tests for hepatitis B surface antigen or hepatitis C ribonucleic acid (RNA)

Sponsors & Collaborators

• Columbia University: lead
• Novartis: collaborator

Study Sites (1)

Columbia University Irving Medical Center

New York, New York, 10032, United States

Location

MeSH Terms

Conditions

Carcinoma, Renal Cell

Interventions

spartalizumab; canakinumab

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Kidney Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases

Study Officials

• Karie D. Runcie, MD

  Columbia University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Medicine

Model Details: This is a pilot study

Study Record Dates

• First Submitted: July 18, 2019
• First Posted: July 22, 2019
• Study Start: August 15, 2019
• Primary Completion: March 14, 2025
• Study Completion: March 5, 2026
• Last Updated: April 15, 2026

Record last verified: 2026-04

Locations

US (1)