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

Completed · Early Phase 1

Conditions studied: Carcinoma, Renal Cell

In brief

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 facts

Study ID

NCT04028245

Run by

Columbia University

People needed

17

Starts

2019-08-15

Expected to finish

2026-03-05

Last updated by the study team

2026-04-15

Who can join

Age: 18 and older, up to 99. Sex: any. Healthy volunteers: not accepted.

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
• Serum creatinine ≤ 1.5 x ULN or serum creatinine > 1.5 - 3 x ULN if calculated
• creatinine clearance (CrCl) is ≥ 30 mL/min
• For patients with known chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated
• For patients with a history of hepatitis C virus (HCV) infection, the infection must be treated and cured
• Willingness to provide written informed consent and HIPAA authorization for the release of personal health information, and the ability to comply with the study requirements (note: HIPAA authorization will be included in the informed consent)
• Willingness to use barrier contraception from the time of first dose of canakinumab and spartalizumab until 120 days after surgical intervention

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)
• History of known or suspected autoimmune disease with the following exceptions:
• Vitiligo
• Resolved childhood atopic dermatitis
• Psoriasis (with exception of psoriatic arthritis) not requiring systemic treatment (within the past 2 years).
• Patients with Grave's disease or Hashimoto's thyroiditis that are now euthyroid clinically and by laboratory testing.
• History of malignancy within the last 2 years, with the exception of non-melanoma skin cancers and superficial bladder cancer
• Uncontrolled major active infectious, cardiovascular, pulmonary, hematologic, or psychiatric illnesses that would make the patient a poor study candidate

Where it is running

• Columbia University Irving Medical Center — New York, New York, United States

Full record on ClinicalTrials.gov

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