Combining two immunotherapies for localized clear cell kidney cancer
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)
Run by Columbia University · NCT04028245 · Data updated 2026-05-14
This study is no longer in our active list. It may have stopped recruiting or finished. The details below are as of 2026-05-14 and are kept for reference. Check ClinicalTrials.gov for its current status, or see similar studies below.
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 |
| Ages | 18 Years to 99 Years |
| Sex | All |
| Enrollment | 14 (estimated) |
| 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 |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates include adults aged 18 and older with localized, non-metastatic clear cell RCC scheduled for nephrectomy.
✕Probably not a fit
Patients with metastatic RCC or those with severe autoimmune conditions may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: 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.
Who can join: the full rules
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 it's running
-
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
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
Canakinumab use in Schnitzler’s syndrome in real-world patients
This study tests how well and how safely canakinumab works for people diagnosed with Schnitzler’s syndrome who are taking it in routine clinical care.
-
Canakinumab use in FMF and Still's disease patients across real-world care
This real-world study looks at how people with FMF or Still's disease who were treated with canakinumab fare over at least 6 months.
-
Belzutifan plus zanzalintinib versus belzutifan alone for advanced renal cell carcinoma
This trial tests whether adding the targeted drug zanzalintinib to belzutifan helps people with advanced renal cell carcinoma live longer and delay tumor growth compared with belzutifan plus placebo.
-
PF-08634404 alone and with other anticancer medicines for adults with advanced kidney cancer.
This tests whether PF-08634404, given alone or with other cancer medicines, is safe and helps adults with locally advanced or metastatic kidney cancer who have not had prior systemic treatment.
-
Deep-learning tool to distinguish T1–T2 from T3 renal cell carcinoma on contrast-enhanced CT.
This project will see if a computer model can tell whether kidney cancer is early (T1–T2) or locally advanced (T3) using contrast-enhanced CT scans before surgery.
-
Using vorolanib for treating advanced kidney cancer
This study is testing if the drug vorolanib can help people with advanced kidney cancer live longer when used as a second treatment option.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.