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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
Age ≥ 18 years old at time of consent
Eastern Cooperative Oncology Group (ECOG) score of 0 or 1
Must not have
Allogenic bone marrow or solid organ transplant
Uncontrolled major active infectious, cardiovascular, pulmonary, hematologic, or psychiatric illnesses that would make the patient a poor study candidate
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 weeks
Awards & highlights
No Placebo-Only Group

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.
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.
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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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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 haven't had any major AIDS-related infections in the past year.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have had a bone marrow or organ transplant from another person.
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I do not have any severe infections or heart, lung, blood, or mental health conditions that would make me unsuitable for the study.
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I have had treatment for kidney cancer, including surgery or other therapies.
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I have previously received experimental cancer vaccines or immune therapy.
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I have not been treated with drugs that target immune checkpoints.
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I have or had lung disease or inflammation needing home oxygen.
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My cancer has spread to distant parts of my body.
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I do not have any active infections.
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I haven't taken high-dose steroids or immunosuppressants in the last week.
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I do not have severe ongoing issues with my liver, blood, stomach, hormones, lungs, or heart unrelated to my kidney cancer.

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

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

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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
2017
Completed Phase 3
~840

Find a Location

Who is running the clinical trial?

Columbia UniversityLead Sponsor
1,486 Previous Clinical Trials
2,663,176 Total Patients Enrolled
NovartisIndustry Sponsor
1,636 Previous Clinical Trials
2,773,556 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
~2 spots leftby Dec 2025
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