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Canakinumab + Spartalizumab for Renal Cell Carcinoma (SPARC-1 Trial)
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.
SPARC-1 Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSPARC-1 Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2017 Phase 3 trial • 203 Patients • NCT02059291SPARC-1 Trial Design
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Who is running the clinical trial?
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- I have not received any live vaccines in the last 4 weeks.I am 18 years old or older.I agree to use barrier contraception until 120 days after my surgery.I have had a bone marrow or organ transplant from another person.I do not have any severe infections or heart, lung, blood, or mental health conditions that would make me unsuitable for the study.I have had treatment for kidney cancer, including surgery or other therapies.I haven't had cancer in the past 2 years, except for skin or superficial bladder cancer.I am fully active or have some restrictions but can still care for myself.I have not had surgery in the last 28 days.My kidney cancer has not spread beyond my kidney.You have a history of autoimmune disease, except for certain specific cases.My kidney cancer is mainly clear cell type.You have a known autoimmune disease that is currently active.I have previously received experimental cancer vaccines or immune therapy.My CD4+ T cell count is 350 or higher, or my HIV is undetectable.I am scheduled for kidney surgery as part of my treatment.I have not been treated with drugs that target immune checkpoints.You have had serious allergic reactions to other similar types of medications.I have or had lung disease or inflammation needing home oxygen.I am HIV positive but in good health with a low risk of developing AIDS.I haven't had any major AIDS-related infections in the past year.You have tested positive for hepatitis B or hepatitis C.My cancer has spread to distant parts of my body.I do not have any active infections.I haven't taken high-dose steroids or immunosuppressants in the last week.I do not have severe ongoing issues with my liver, blood, stomach, hormones, lungs, or heart unrelated to my kidney cancer.My organ and bone marrow functions are normal.You have had a serious allergic reaction to other types of antibodies.
- Group 1: Spartalizumab and Canakinumab
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
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."
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."
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"
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."
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)."
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."
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."
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