A Study of Combination Spartalizumab and Canakinumab in Patients With Localized Clear Cell Renal Cell Carcinoma (SPARC-1)

  • STATUS
    Recruiting
  • End date
    Dec 6, 2026
  • participants needed
    14
  • sponsor
    Columbia University
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Updated on 6 April 2023
See if I qualify
carcinoma
neutrophil count
nephrectomy
clear cell renal cell carcinoma

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

Description

Patients with localized and non-metastatic Renal Cell Carcinoma (RCC) represent an "at-need" population who would benefit from immunotherapy earlier in their disease course with a programmed cell death protein 1(PD-1) therapy combined with a second immunotherapy agent. A logical next step is to pursue the combination of an anti- programmed cell death protein 1(PD1) therapy with cytotoxic T-lymphocyte associated protein 4 (CTLA-4) blockade extrapolating from recent successes in the metastatic setting. The primary concern with previous approaches and studies is that CTLA-4 based therapy is associated with increased risk of autoimmune side effects which potentially could delay a curative surgery. Clearly, the neoadjuvant setting in RCC represents an ideal space to evaluate novel I/O combination strategies aside from CTLA-4 blockade.

This study intends 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. This is a single-center, single arm, open-label pilot study evaluating the feasibility, safety, anti-tumor effect, and immunogenicity of neoadjuvant canakinumab and spartalizumab given prior to radical nephrectomy in patients with localized renal cell carcinoma. Patients will be recruited from the outpatient Urology clinic.

Eligible patients will receive canakinumab at a dose of 300 mg Q4weeks and spartalizumab at 400 mg Q4weeks IV. Approximately 14 days after the last dose of canakinumab and spartalizumab, patients with proceed to radical nephrectomy, and nephrectomy tissue will be examined for the secondary endpoints. Follow-up evaluation for adverse events will occur 30 days and 90 days after surgery. Patients will then be followed by their urologists and oncologist according to standard institutional practices, but will require repeat labs every 3 months along with standard of care surveillance imaging.

Details
Condition Carcinoma, Renal Cell
Treatment canakinumab, spartalizumab
Clinical Study IdentifierNCT04028245
SponsorColumbia University
Last Modified on6 April 2023

Eligibility

 Yes No Not Sure

Inclusion Criteria

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
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)
must be undetectable on suppressive therapy, if indicated
Willingness to use barrier contraception from the time of first dose of canakinumab and spartalizumab until 120 days after surgical intervention
For patients with a history of hepatitis C virus (HCV) infection, the infection must be treated and cured

Exclusion Criteria

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)
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
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
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
Uncontrolled major active infectious, cardiovascular, pulmonary, hematologic, or psychiatric illnesses that would make the patient a poor study candidate
History of malignancy within the last 2 years, with the exception of non-melanoma skin
cancers and superficial bladder cancer
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