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Monoclonal Antibodies

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

Q: 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.

Q: 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, <a href="https://www.withpower.com/clinical-trials/texas">Texas</a> administering this medication, 1,069 medical centres worldwide are participating in its research.

Q: May I partake in this clinical exploration?

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

Q: 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.

Q: What therapeutic purposes does Canakinumab serve?

The drug canakinumab is often deployed to manage muckle-wells syndrome (MWS), active systemic juvenile idiopathic <a href="https://www.withpower.com/clinical-trials/arthritis">arthritis</a>, and neonatal-onset multisystem inflammatory disease (NOMID).

Q: 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.

Q: 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.

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

Select...

I agree to use barrier contraception until 120 days after my surgery.

Select...

I am 18 years old or older.

Select...

I am fully active or have some restrictions but can still care for myself.

Select...

My kidney cancer has not spread beyond my kidney.

Select...

My kidney cancer is mainly clear cell type.

Select...

My CD4+ T cell count is 350 or higher, or my HIV is undetectable.

Select...

I am scheduled for kidney surgery as part of my treatment.

Select...

I am HIV positive but in good health with a low risk of developing AIDS.

Select...

I haven't had any major AIDS-related infections in the past year.

Select...

My organ and bone marrow functions are normal.

SPARC-1 Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 weeks

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%

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

0 / 10Eligibility criteria met

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

Recent research and studies

clinicaltrials.govStudy

A Study of Combination Spartalizumab and Canakinumab in Patients With Localized Clear Cell Renal Cell Carcinoma

Karie D. Runcie, MD 2019. "A Study of Combination Spartalizumab and Canakinumab in Patients With Localized Clear Cell Renal Cell Carcinoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04028245.

All > Renal Cell Carcinoma