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Checkpoint Inhibitor
Treatment for Prostate Cancer
Phase 1
Waitlist Available
Led By Mark Scholz, MD
Research Sponsored by Prostate Oncology Specialists, Inc.
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 duration of the study, an expected average of 18 months
Awards & highlights
All Individual Drugs Already Approved
No Placebo-Only Group
Summary
This is a clinical trial designed to quantify the immune response and determine the tolerability and side effects of sipuleucel-T when given in combination with ipilimumab for patients with advanced prostate cancer.
Eligible Conditions
- Prostate Cancer
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ duration of the study, an expected average of 18 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~duration of the study, an expected average of 18 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Antibody responses against PA2024 and PAP
Antigen-specific T cell proliferation to PA2024, PAP and PHA
Antigen-specific memory T cell response
Secondary study objectives
Percentage PSA decline
Prostate-Specific Antigen (PSA) doubling time
Time to PSA progression
+1 moreAwards & Highlights
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
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: TreatmentExperimental Treatment2 Interventions
Patients enrolled will receive the standard 3-dose treatment of sipuleucel-T, followed by treatment(s) of ipilimumab.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Sipuleucel-T
FDA approved
Ipilimumab
FDA approved
Find a Location
Who is running the clinical trial?
Prostate Oncology Specialists, Inc.Lead Sponsor
Mark Scholz, MDPrincipal InvestigatorProstate Oncology Specialists, Inc.
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