Carcinoma, Renal CellEarly Phase 1SPARC-1NCT04028245
A Study of Combination Spartalizumab and Canakinumab in Patients With Localized Clear Cell Renal Cell Carcinoma
A Early Phase 1 study testing Spartalizumab and Canakinumab in people with Carcinoma, Renal Cell, run by Columbia University at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Carcinoma, Renal Cell
- What is being tested?
- Spartalizumab and Canakinumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Aug 2019to 5 Mar 2026
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Columbia University Irving Medical Center
New York, New York, 10032
About this study
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)
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
Read the 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 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.
- Conditions
- Carcinoma, Renal Cell
- Being tested
- Spartalizumab, Canakinumab
- Medical subject headings
- Carcinoma, Renal Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SpartalizumabDrug
Also called PDR-001
Spartalizumab at 400 mg weeks x 2 doses prior to radical nephrectomy Infusion
CanakinumabDrug
Also called ACZ885
Canakinumab 300 mg IV Q4 weeks x 2 doses prior to radical nephrectomy Infusion
| Study group | Role | What they receive |
|---|---|---|
| Spartalizumab and Canakinumab | Experimental | Subjects with renal cell carcinoma will receive study treatment Q4 weeks x 2 doses prior to radical nephrectomy. Receives: Drug: Spartalizumab; Drug: Canakinumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of subjects who proceed to radical nephrectomy
Feasibility of spartalizumab and canakinumab will be met if > 85% of patients proceed to radical nephrectomy (12 of 14).
Measured: 6 Weeks
Secondary outcomes (3)
Quantification of cluster of differentiation 8 (CD8) T cell infiltration into the tumor / peritumoral area infiltrates
To assess the immune response to combination canakinumab and spartalizumab. Tumor blocks and/or additional unstained slides will be collected for study-specific quantitative immunohistochemical evaluations. Cell infiltration into the kidney resection specimens will be quantified as the mean staining percentage, using immunohistochemical staining methods.
Measured: 6 Weeks
Quantification of immune cell populations (PMN-MDSC) in the tumor/ peritumoral area
To assess the immune response to combination canakinumab and spartalizumab. Tumor blocks and/or additional unstained slides will be collected for study-specific quantitative immunohistochemical evaluations. Cell infiltration into the kidney resection specimens will be quantified using immunohistochemical staining methods which will attempt to determine the potential potential ratio of CD8 and the regulatory T cells (Treg).
Measured: 6 Weeks
Objective tumor response rate
To assess the immune response to combination canakinumab and spartalizumab. By RECIST and by Immunotherapeutics Response Evaluation Criteria in Solid Tumours (iRECIST), proportion of pathologic complete response (pathCR (pT0)) and downstaging (decrease in size from baseline scans) will be calculated.
Measured: 6 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2019
- Study start15 Aug 2019
- Primary completion14 Mar 2025
- Study completion5 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carcinoma, Renal CellStudies of the same condition, open and under way.
- More trials run by Columbia UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This is a pilot study
- Masking
- None (open label)
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Columbia University
- Sponsor type
- University, hospital or other
- Collaborators
- Novartis
- Responsible party
- Principal investigator, Karie D. Runcie, MD, Columbia University
- Investigators
- Karie D. Runcie, MD, Principal investigator, Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04028245
- Sponsor's protocol ID
- AAAS2814
- Acronym
- SPARC-1
- Status last verified
- Apr 2026
- First submitted
- 18 Jul 2019
- Last updated
- 15 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT04028245
- Acronym / sponsor ID
- SPARC-1 / AAAS2814
- Conditions
- Carcinoma, Renal Cell
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Columbia UniversityUniversity, hospital or other
- Collaborators
- Novartis
- Study start
- 15 Aug 2019 (actual)
- Primary completion
- 14 Mar 2025 (actual)
- Study completion
- 5 Mar 2026 (actual)
- First posted
- 22 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This is a pilot study
| Arm | Type | Receives |
|---|---|---|
| Spartalizumab and Canakinumab | Experimental | Drug: Spartalizumab, Drug: CanakinumabSubjects with renal cell carcinoma will receive study treatment Q4 weeks x 2 doses prior to radical nephrectomy. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (21 listed)
- 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
Key exclusion criteria (22 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SpartalizumabAlso: PDR-001Spartalizumab at 400 mg weeks x 2 doses prior to radical nephrectomy Infusion | Drug | Spartalizumab and Canakinumab |
| CanakinumabAlso: ACZ885Canakinumab 300 mg IV Q4 weeks x 2 doses prior to radical nephrectomy Infusion | Drug | Spartalizumab and Canakinumab |
Primary outcome
Percentage of subjects who proceed to radical nephrectomy
Time frame: 6 Weeks
Feasibility of spartalizumab and canakinumab will be met if > 85% of patients proceed to radical nephrectomy (12 of 14).
3 secondary outcomes
Quantification of cluster of differentiation 8 (CD8) T cell infiltration into the tumor / peritumoral area infiltrates
Time frame: 6 Weeks
Quantification of immune cell populations (PMN-MDSC) in the tumor/ peritumoral area
Time frame: 6 Weeks
Objective tumor response rate
Time frame: 6 Weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Karie D. Runcie, MD principal investigator
Columbia University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Spartalizumab and Canakinumab in people with Carcinoma, Renal Cell, run by Columbia University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 21 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of subjects who proceed to radical nephrectomy (time frame: 6 Weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Apr 2026.