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Monoclonal Antibodies

Canakinumab + Spartalizumab for Renal Cell Carcinoma (SPARC-1 Trial)

Phase < 1
Recruiting
Led By Matthew Dallos, MD
Research Sponsored by Columbia University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Willingness to use barrier contraception from the time of first dose of canakinumab and spartalizumab until 120 days after surgical intervention
Age ≥ 18 years old at time of consent
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 weeks
Awards & highlights

SPARC-1 Trial Summary

This trial is testing a new cancer treatment involving two drugs, canakinumab and spartalizumab, to see if it is safe and effective. The trial will also assess the immune response to the treatment and the anti-tumor activity.

Who is the study for?
This trial is for adults with localized clear cell Renal Cell Carcinoma (RCC) who are scheduled for kidney surgery. They must be willing to use barrier contraception, have no history of severe infections or autoimmune diseases, and not have received prior RCC treatments or immune-modulating drugs. HIV-positive patients can join if they're healthy with controlled viral loads.Check my eligibility
What is being tested?
The study tests the safety and effectiveness of combining two drugs, Spartalizumab and Canakinumab, before kidney surgery in RCC patients. It aims to see how well this combination works in shrinking tumors and enhancing the body's immune response against cancer.See study design
What are the potential side effects?
Potential side effects may include reactions related to the immune system such as inflammation in various organs, infusion-related reactions due to drug administration, increased risk of infections, and possibly other symptoms that are common with monoclonal antibody therapies.

SPARC-1 Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I agree to use barrier contraception until 120 days after my surgery.
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I am 18 years old or older.
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I am fully active or have some restrictions but can still care for myself.
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My kidney cancer has not spread beyond my kidney.
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My kidney cancer is mainly clear cell type.
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My CD4+ T cell count is 350 or higher, or my HIV is undetectable.
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I am scheduled for kidney surgery as part of my treatment.
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I am HIV positive but in good health with a low risk of developing AIDS.
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I haven't had any major AIDS-related infections in the past year.
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My organ and bone marrow functions are normal.

SPARC-1 Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Percentage of subjects who proceed to radical nephrectomy
Secondary outcome measures
Objective tumor response rate
Quantification of cluster of differentiation 8 (CD8) T cell infiltration into the tumor / peritumoral area infiltrates
Quantification of immune cell populations (PMN-MDSC) in the tumor/ peritumoral area

Side effects data

From 2017 Phase 3 trial • 203 Patients • NCT02059291
50%
Bronchitis
50%
Diarrhoea
50%
Conjunctivitis
50%
Gastroenteritis
50%
Drug eruption
25%
Teething
25%
Pyogenic granuloma
25%
Dental caries
25%
Eye allergy
25%
Gastritis
25%
Nausea
25%
Vomiting
25%
Nasopharyngitis
25%
Malaise
25%
Aspartate aminotransferase increased
25%
Tonsillitis bacterial
25%
Alanine aminotransferase increased
25%
Neutrophil count increased
25%
Pain in extremity
25%
Headache
25%
Dermatitis allergic
25%
Pyoderma gangrenosum
25%
Rash pruritic
25%
Scleritis
25%
Hyper IgD syndrome
25%
Eye pain
25%
Familial mediterranean fever
25%
Constipation
25%
Stomatitis
25%
Influenza
25%
Rhinitis
25%
Sialoadenitis
25%
Viral upper respiratory tract infection
25%
C-reactive protein increased
25%
Neutrophil count decreased
25%
Serum amyloid A protein increased
25%
White blood cell count increased
25%
Hypocalcaemia
25%
Arthralgia
25%
Back pain
25%
Somnolence
25%
Eczema
25%
Keloid scar
25%
Urticaria
25%
Aphthous ulcer
25%
Ear infection
25%
Hypophosphataemia
25%
Pancytopenia
25%
Hepatic failure
25%
Laryngitis
25%
Haemorrhoids
25%
Pyrexia
25%
Viral tonsillitis
25%
Dehydration
25%
Pain of skin
25%
Skin ulcer
100%
80%
60%
40%
20%
0%
Study treatment Arm
Non-randomized Open Label crFMF, HIDS/MKD Patients
Randomized ACZ and Placebo TRAPS Patients - ACZ Events
Randomized ACZ and Placebo HIDS/MKD Pts - No Medication Events
Randomized ACZ and Placebo HIDS/MKD Patients - ACZ Events
Randomized ACZ and Placebo crFMF Patients - ACZ Events
Any ACZ crFMF Patients - ACZ Events
Randomized ACZ and Placebo crFMF Pts - No Medication Events
Non-randomized Open Label TRAPS Patients
Any ACZ crFMF Patients - Placebo Events
Randomized ACZ and Placebo TRAPS Patients - Placebo Events
Randomized ACZ and Placebo TRAPS Pts - No Medication Events
Any ACZ HIDS/MKD Patients - No Medication Events
Any ACZ HIDS/MKD Patients - ACZ Events
Randomized ACZ and Placebo HIDS/MKD Pts - Placebo Events
Any ACZ TRAPS Patients - Placebo Events
Any ACZ TRAPS Patients - ACZ Events
Randomized ACZ and Placebo crFMF Patients - Placebo Events
Any ACZ TRAPS Patients - no Medication Events
Any ACZ HIDS/MKD Patients - Placebo Events
Any ACZ crFMF Patients - No Medication Events

SPARC-1 Trial Design

1Treatment groups
Experimental Treatment
Group I: Spartalizumab and CanakinumabExperimental Treatment2 Interventions
Subjects with renal cell carcinoma will receive study treatment Q4 weeks x 2 doses prior to radical nephrectomy.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Canakinumab
2011
Completed Phase 3
~3090
Spartalizumab
2020
Completed Phase 2
~280

Find a Location

Who is running the clinical trial?

NovartisIndustry Sponsor
1,610 Previous Clinical Trials
2,719,256 Total Patients Enrolled
Columbia UniversityLead Sponsor
1,431 Previous Clinical Trials
2,460,819 Total Patients Enrolled
Matthew DallosLead Sponsor
3 Previous Clinical Trials
129 Total Patients Enrolled

Media Library

Canakinumab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT04028245 — Phase < 1
Renal Cell Carcinoma Research Study Groups: Spartalizumab and Canakinumab
Renal Cell Carcinoma Clinical Trial 2023: Canakinumab Highlights & Side Effects. Trial Name: NCT04028245 — Phase < 1
Canakinumab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04028245 — Phase < 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any current vacancies in this research project?

"The clinical trial, initially published on August 15th 2019 and recently updated on May 6th 2022 is actively seeking volunteers."

Answered by AI

What prior investigations have taken place involving Canakinumab?

"At the present moment, 4 clinical trials for Canakinumab have entered Phase 3 with a total of 39 ongoing studies. Whilst there are many sites in Houston, Texas administering this medication, 1,069 medical centres worldwide are participating in its research."

Answered by AI

May I partake in this clinical exploration?

"This clinical trial is seeking 14 individuals aged 18 to 99 who have a diagnosis of renal cell carcinoma. To be eligible, participants must also exhibit the following characteristics: CD4+ T lymphocyte value ≥ 350 cells/microliter OR no detectable HIV viral loads; CT scan and histology-confirmed clear cell RCC or predominantly clear cell RCC; localized non-metastatic cancer (T1b - T4NanyM0 or TanyN1M0); planned partial/radical nephrectomy procedure within their treatment plan; Eastern Cooperative Oncology Group score 0 or 1; healthy HIV infection status with low"

Answered by AI

Is this investigation the inaugural exploration of its kind?

"The first trial on Canakinumab dates back to 2011, and was led by Novartis Pharmaceuticals. After the success of this initial study (185 patients), Phase 1 approval for the drug was granted. Currently there are 39 active clinical trials involving canakinumab across 53 nations in 319 cities."

Answered by AI

What therapeutic purposes does Canakinumab serve?

"The drug canakinumab is often deployed to manage muckle-wells syndrome (MWS), active systemic juvenile idiopathic arthritis, and neonatal-onset multisystem inflammatory disease (NOMID)."

Answered by AI

Does this research trial permit those over 35 to participate?

"The prerequisites for this research indicate that eligible participants must range from 18 to 99 in age. There are 86 studies available targeting minors and 2,607 trials specifically geared towards the elderly population."

Answered by AI

What is the participant capacity for this research project?

"Affirmative. According to clinicaltrials.gov, this experiment is still recruiting participants - the first posting of which was on August 15th 2019 with the latest update occurring on May 6th 2022. A mere 14 patients must be recruited from a single site in order to complete the trial."

Answered by AI
~4 spots leftby Dec 2025