Number of Participants Progression-free at 18 Months
| Group | Value (participants) |
|---|---|
| Entire Study Population | 0 |
Trial · Interventional
CompletedPhase 2Results postedRegistry dataUnited States
1 trial · 1 completed · 1 with posted results
Hormone Therapy and Ipilimumab in Treating Patients With Advanced Prostate Cancer
NCT00170157Jun 2004 to Jun 2013
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
RATIONALE: Androgens can cause the growth of prostate cancer cells. Antihormone therapy, such as leuprolide acetate, goserelin, flutamide, or bicalutamide may lessen the amount of androgens made by the body. Monoclonal antibodies, such as ipilimumab, can block cancer growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry cancer-killing substances to them. Giving antihormone therapy together with ipilimumab may kill more tumor cells. PURPOSE: This randomized phase II trial is study how well giving hormone therapy and ipilimumab together works in treating patients with advanced prostate cancer.
Experimental
Arm I
Patients receive either leuprolide acetate intramuscularly (IM) or goserelin subcutaneously (SC) on days 0, 28, and 56. Patients also receive oral flutamide three times daily or oral bicalutamide once daily. Treatment with antiandrogen (AA) therapy continues for 3 months (3-4 months for patients who initiated AA therapy \<= 21 days prior to enrollment) in the absence of disease progression or unacceptable toxicity. Patients receive ipilimumab IV over 90 minutes on day 7 (within 7-28 days post-initiation of AA therapy for patients who initiated AA therapy \<= 21 days prior to enrollment) of AA therapy.
Active comparator
Arm II
Patients receive AA therapy as in arm I. Patients may crossover to arm II in the case of disease progression.
Outcomes the sponsor listed as primary.
Number of Participants Progression-free at 18 Months
Time frame · 18 months from the start of AA therapy
PSA progression is defined as a rise in PSA to \>4.0 ng/mL demonstrated twice in measurements taken two weeks apart.
Percent of Participants With Undetectable Prostate-specific Antigen (PSA) Response
Time frame · 3 months
Percent of participants who had undetectable PSA at 3 months on the initially assigned treatment arm (prior to crossing over).
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
| Group | Value (participants) |
|---|---|
| Entire Study Population | 0 |
| Group | Value (percentage of participants) |
|---|---|
| Androgen Ablative (AA) Therapy + MDX-010 | 55 |
| Androgen Ablative (AA) Then AA Therapy + MDX-010 | 39 |
| Group | Deaths | Serious events | Other events |
|---|---|---|---|
| Entire Study PopulationAll participants (Androgen ablative (AA) therapy + MDX-010 and Androgen ablative (AA) therapy alone the AA Therapy + MDX-010) were grouped together for this outcome. | – | 10 / 110 | 107 / 110 |
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