Ipilimumab + Androgen Deprivation Therapy in Prostate Cancer
|ClinicalTrials.gov Identifier: NCT01377389|
Recruitment Status : Completed
First Posted : June 21, 2011
Last Update Posted : April 12, 2017
|Condition or disease||Intervention/treatment||Phase|
|Prostate Cancer||Drug: Ipilimumab Drug: Leuprolide Drug: Goserelin Drug: Degarelix||Phase 2|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Study of Ipilimumab PLUS Androgen Deprivation Therapy in Castrate Sensitive Prostate Carcinoma|
|Actual Study Start Date :||June 17, 2011|
|Primary Completion Date :||April 7, 2017|
|Study Completion Date :||April 7, 2017|
Experimental: Ipilimumab + ADT
Ipilimumab 10 mg/kg intravenous (IV) Weeks 5, 9, 13, and 17 plus Androgen Deprivation 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.
10 mg/kg by vein over 90 minutes once every 4 weeks, for 4 weeks.
Other Names:Drug: Leuprolide
7.5 mg intramuscular once a month for 8 months
Other Names:Drug: Goserelin
3.6 mg subcutaneous once a month for 8 months
Other Name: ZoladexDrug: Degarelix
80 mg subcutaneous once a month for 8 months
Other Name: Firmagon
- Proportion of Participants achieving a PSA ≤ 0.2ng/mL at Month 7 [ Time Frame: Baseline to 7 months ]Prostate-specific antigen (PSA) conducted by the Simon's optimal two-stage design (Simon, 1989). Antitumor activity assessed through serial PSA measurements (blood tests) at pre-determined time points.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01377389
|United States, Texas|
|University of Texas MD Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Ana M. Aparicio, MD||M.D. Anderson Cancer Center|