Status:
ACTIVE_NOT_RECRUITING
A Study of Combination Spartalizumab and Canakinumab in Patients With Localized Clear Cell Renal Cell Carcinoma
Lead Sponsor:
Columbia University
Collaborating Sponsors:
Novartis
Conditions:
Carcinoma, Renal Cell
Eligibility:
All Genders
18-99 years
Phase:
EARLY_PHASE1
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...
Detailed 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 deat...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
August 15 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2026
Estimated Enrollment :
17 Patients enrolled
Trial Details
Trial ID
NCT04028245
Start Date
August 15 2019
End Date
March 1 2026
Last Update
August 7 2025
Active Locations (1)
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1
Columbia University Irving Medical Center
New York, New York, United States, 10032