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Cytokine
Pembrolizumab for Renal Cell Carcinoma
Phase 1
Waitlist Available
Led By Scott S. Tykodi
Research Sponsored by University of Washington
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at baseline and every 3 months
Awards & highlights
Summary
This trial is testing the side effects and best dose of aldesleukin when given with pembrolizumab to treat patients with kidney cancer.
Eligible Conditions
- Renal Cell Carcinoma
- Kidney Cancer
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ at baseline and every 3 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at baseline and every 3 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Incidence of adverse events
Secondary study objectives
Anti-tumor activity
Change in performance status
Disease control rate (DCR)
+2 moreOther study objectives
Absolute numbers of effector T cells (Teff)
Absolute numbers of regulatory T cells (Treg)
Chromosomal copy number alterations
+3 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: Treatment (pembrolizumab, aldesleukin)Experimental Treatment2 Interventions
Patients receive pembrolizumab intravenously (IV) over 30 minutes on day 1. Patients also receive aldesleukin subcutaneously (SC) 5 days per week for 6 weeks; or aldesleukin IV on days 2-6 of pembrolizumab cycles 1 and 2. Pembrolizumab treatment repeats every 3 weeks for 4 cycles per treatment course in the absence of clinical disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pembrolizumab
2017
Completed Phase 3
~2850
Aldesleukin
2012
Completed Phase 4
~1620
Find a Location
Who is running the clinical trial?
University of WashingtonLead Sponsor
1,801 Previous Clinical Trials
1,908,844 Total Patients Enrolled
Merck Sharp & Dohme LLCIndustry Sponsor
3,960 Previous Clinical Trials
5,176,531 Total Patients Enrolled
Prometheus LaboratoriesIndustry Sponsor
26 Previous Clinical Trials
4,790 Total Patients Enrolled
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