Immunologic Response: Number of Participants With Immune Response
| Group | Value (Participants) |
|---|---|
| Neoadjuvant Ipilimumab | 12 |
Trial · Interventional
CompletedPhase 2Results postedRegistry dataUnited States
1 trial · 1 completed · 1 with posted results
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
The goal of this clinical research study is to learn how ipilimumab in combination with Lupron (leuprolide acetate) affects the body's own defense (immune) system before having surgery to remove prostate cancer. The safety of the drug combination will also be studied.
Experimental
Neoadjuvant Ipilimumab
Leuprolide Acetate 22.5 mg administered as a single intramuscular 3 month depot + Ipilimumab 10 mg/kg by vein administered as 2 single doses, 3 weeks apart after hormone therapy + Radical Prostatectomy Surgery to remove prostate gland approximately 4 weeks after the second dose of Ipilimumab.
Outcomes the sponsor listed as primary.
Immunologic Response: Number of Participants With Immune Response
Time frame · Baseline to Week 8
Immunological response assays were measured at several time points starting at baseline until the eighth week after starting the medicine for each participant. The immunological responses measured were Cluster of Differentiation 4 (CD4), Cluster of Differentiation 8 (CD8) and Inducible T-cell Costimulatory (ICOS) markers. T-cells with the CD4 marker help coordinate the immune system response to an invader. Killer T-cells have the CD8 marker and are responsible for killing the invader. ICOS is a molecule which stimulates the activity of the immune response of the killer T-Cells and memory T cells. Participants with at least a 2 fold increase in the presence of CD4, CD8, or ICOS markers from the participant's baseline measure were considered a responder for that marker.
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
| Group | Value (Participants) |
|---|---|
| Neoadjuvant Ipilimumab | 12 |
| Group | Deaths | Serious events | Other events |
|---|---|---|---|
| Neoadjuvant IpilimumabLeuprolide Acetate 22.5 mg administered as a single intramuscular 3 month depot + Ipilimumab 10 mg/kg by vein administered as 2 single doses, 3 weeks apart after hormone therapy + Radical Prostatectomy Surgery to remove prostate gland approximately 4 weeks after the second dose of Ipilimumab. | 1 / 17 | 2 / 17 | 17 / 17 |
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