Combining two immunotherapies for localized clear cell kidney cancer
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)
This study is testing a combination of two immunotherapies in people with localized clear cell kidney cancer to see if it helps their immune system fight the cancer before surgery.
Quick facts
| Phase | Early Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 14 (estimated) |
| Ages | 18 Years to 99 Years |
| Sex | All |
| Sponsor | Columbia University Academic / other |
| Drugs / interventions | canakinumab, spartalizumab, radiation, prednisone, immunotherapy |
| Locations | 1 site (New York, New York) |
| Trial ID | NCT04028245 on ClinicalTrials.gov |
What this trial studies
This study evaluates the safety and feasibility of administering canakinumab and spartalizumab in patients with localized clear cell renal cell carcinoma (RCC) before surgery. It aims to assess the immune response and anti-tumor activity of this combination therapy in a neoadjuvant setting. Patients will receive these treatments intravenously at specified doses every four weeks, followed by radical nephrectomy. The study is designed as a single-center, open-label pilot study to gather preliminary data on this novel approach.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with localized, non-metastatic clear cell RCC scheduled for nephrectomy.
Not a fit: Patients with metastatic RCC or those with severe autoimmune conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this combination therapy could improve treatment outcomes for patients with localized clear cell RCC by enhancing immune response and reducing tumor size before surgery.
How similar studies have performed: While similar immunotherapy combinations have shown promise in metastatic settings, this specific approach in the neoadjuvant context is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
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 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 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) * 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 this trial is running
New York, New York
- Columbia University Irving Medical Center — New York, New York, United States (Recruiting)
Study contacts
- Principal investigator: Karie D. Runcie, MD — Columbia University
- Study coordinator: Research Nurse Navigator
- Email: cancerclinicaltrials@cumc.columbia.edu
- Phone: 212-342-5162
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.