ACTIVE_NOT_RECRUITING

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

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Official Title

A Pilot Study of Neoadjuvant Combination Spartalizumab and Canakinumab Prior to Radical Nephrectomy in Patients With Localized Clear Cell Renal Cell Carcinoma (SPARC-1 Trial)

Quick Facts

Study Start:2019-08-15

Study Completion:2026-03

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:ACTIVE_NOT_RECRUITING

Study ID

NCT04028245

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 99 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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 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	* 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

Inclusion Criteria

Exclusion 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 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

* 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

Contacts and Locations

Principal Investigator

Karie D. Runcie, MD

PRINCIPAL_INVESTIGATOR

Columbia University

Study Locations (Sites)

Columbia University Irving Medical Center

New York, New York, 10032

United States

Collaborators and Investigators

Sponsor: Columbia University

Karie D. Runcie, MD, PRINCIPAL_INVESTIGATOR, Columbia University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2019-08-15

Study Completion Date2026-03

Study Record Updates

Study Start Date2019-08-15

Study Completion Date2026-03

Terms related to this study

Additional Relevant MeSH Terms

Carcinoma, Renal Cell