Number of Participants Who Progressed After 7 Months of Being on Treatment
| Group | Value (Participants) |
|---|---|
| Ipilimumab and Androgen Depravation | 6 |
Trial · Interventional
TerminatedPhase 2Results postedRegistry dataThis trial was stopped early.
Reason given at the registry: Due to adverse events
Results were posted for this trial.
United States
1 trial · 1 stopped early · 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 if ipilimumab in combination with either Lupron® (leuprolide), Zoladex® (goserelin), or Firmagon® (degarelix) can affect prostate-specific antigen (PSA) levels in patients with prostate cancer. Researchers also want to learn if these drug combinations affect the body's immune system. The safety of these drug combinations will also be studied.
Experimental
Ipilimumab + ADT
Ipilimumab 10 mg/kg intravenous (IV) Weeks 5, 9, 13, and 17 plus Androgen Depravation Therapy (ADT) of either Leuprolide 7.5 mg intramuscular (IM) , Goserelin 3.6 mg subcutaneous (SQ) or Degarelix 80 mg SQ once a month for 8 months beginning Week 1.
Outcomes the sponsor listed as primary.
Number of Participants Who Progressed After 7 Months of Being on Treatment
Time frame · at the end of 7 months on treatment
Anti-tumor activity assessed through serial PSA measurements (blood tests) at 7 months on treatment. Progression defined as two consecutive PSA values increasing by at least 20% or more from the lowest PSA value for each patient.
The Number of Clonal Expansion of Cluster of Differentiation 8 (CD8) T-cells
Time frame · Each evaluable patient was followed from the time of their first dose until 30 days after their last dose of study drug
CD8 T-cells are known as cytotoxic T-cells or "killer" T-cells. When the resting CD8 T-cells are activated, the activated CD8 T-cells multiple to fight a specific target so creating a group of specifically activated T-cells. This test measured the minimal number of clonal expansions of CD8 T-cells that always preceded an adverse response to treatment that was due to increased activity in the immune system itself. The minimal number of clonal expansion points to what this increased activity in the immune system might look like.
Time to Testosterone Recovery (> 50ng/mL) in Patients Treated With Intermittent ADT Plus Ipilimumab.
Time frame · 1 month up to 7 months.
The presence of testosterone was followed in each patient from the start of treatment until the testosterone lab test was found to be at a value greater than 50ng/mL.
Time to Progression of Disease (PD) Off Androgen Depravation Therapy (ADT), After Treatment With Intermittent ADT Plus Ipilimumab.
Time frame · 2 to 45 months
The number of months after the last ADT dose until the PSA progression
The Total Number of Study Drug Related Events Indicated by the Participants
Time frame · From the first dose to the last follow-up, up to 60 months
The total number of adverse events which were related to one of the study drugs. Grade 1- Mild, asymptomatic of mild symptoms; clinical or diagnostic observation only; intervention not indicated. Grade 2- Moderate, minimal, local or noninvasive intervention indicated; limiting age-appropriate instrumental (daily living activities). Grate 3- Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self care of daily life activities.
Overall Survival
Time frame · From the date of randomization until the date of first documented progression or date of death from any case, whichever came first, assessed up to 70 months.
Overall survival of patients treated with intermittent ADT and ipilimumab in months.
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
| Group | Value (Participants) |
|---|---|
| Ipilimumab and Androgen Depravation | 6 |
| Group | Value (clonal expansions) |
|---|---|
| Ipilimumab and Androgen Depravation | 55 |
| Group | Value (months) |
|---|---|
| Ipilimumab and Androgen Depravation | 3.4 |
| Group | Value (months) |
|---|---|
| Ipilimumab and Androgen Depravation | 8.0 |
| Group | Value (related events) |
|---|---|
| Ipilimumab and Androgen Depravation | 113 |
| Group | Value (months) |
|---|---|
| Ipilimumab and Androgen Depravation | 36 |
| Group | Deaths | Serious events | Other events |
|---|---|---|---|
| Ipilimumab and Androgen DepravationParticipants with castrate sensitive prostate carcinoma | 0 / 27 | 10 / 27 | 27 / 27 |
Each cell reads participants affected / participants at risk, as the registry posted them.
Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works
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