The purpose of this study is to determine if asymptomatic or minimally symptomatic patients with metastatic prostate cancer who have not received chemotherapy live longer when treated with ipilimumab than those treated with a placebo
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
837
5 mg/ml solution, Intravenous, 10 mg/kg, Every 3 weeks for up to 4 doses in the Induction Phase. Every 12 weeks in the Maintenance Phase. Up to 24 weeks in the Induction Phase. Treatment in the Maintenance Phase continues until total treatment period has reached three years,Treatment Stopping Criteria are met, withdrawal of consent, or study closure
Solution, Intravenous, 0 mg, Every 3 weeks for up to 4 doses in the Induction Phase. Every 12 weeks in the Maintenance Phase. Up to 24 weeks in the Induction Phase. Treatment in the Maintenance Phase continues until total treatment period has reached three years,Treatment Stopping Criteria are met, withdrawal of consent, or study closure
Overall Survival (OS) Time
OS was defined as the time from the date of randomization until the date of death. For participants without documentation of death, OS was censored at the last date the participant was known to be alive.
Time frame: Randomization until death from any cause, up to April 2015, approximately 57 months
Progression-Free Survival (PFS) Time
Progression-free survival, as determined by the investigator, was defined as the time from randomization to the earliest date of confirmed Prostate-Specific Antigen (PSA) progression, confirmed radiological progression, clinical deterioration, or death.
Time frame: Randomization until disease progression, up to April 2015, approximately 57 months
Time to Subsequent Non-hormonal Cytotoxic Therapy
For participants who discontinued treatment or experienced disease progression while on study therapy and then received subsequent non-hormonal cytotoxic therapy, time to subsequent non-hormonal cytotoxic therapy was defined as the time from randomization to the time of initiation of subsequent non-hormonal cytotoxic therapy. Participants who did not receive subsequent non-hormonal cytotoxic therapy were censored on the last known alive date (for participants who have not died) or the date of last follow-up contact at which the participants was known alive (for participants who died).
Time frame: Randomization until subsequent non-hormonal cytotoxic therapy, up to April 2015, approximately 57 months
Time to Pain Progression
Time to pain progression was defined as the time from randomization to the time of the earliest date of any of the following 4 events: 1) an increase in average daily worst pain intensity of \>= 2 points from baseline according to the Brief Pain Inventory - Short Form (BPI-SF), maintained over 2 consecutive time periods. 2) initiation of opioid analgesic (excluding codeine or dextropropoxyphene). 3) initiation of palliative radiotherapy for prostate cancer. 4) increase in mean Analgesic Score (AS) of \>= 25% from baseline (for participants with baseline AS \> 10) or increase in mean AS \>= 10 points from baseline (for participants with baseline AS \<= 10). Participants who did not experience any of these events were censored on the earliest date among the latest BPI-SF completion date with non-missing worst pain assessment and last evaluable disease assessment date as defined in the PFS censoring mechanism.
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Alaska Clinical Research Center, Llc
Anchorage, Alaska, United States
Pinnacle Oncology Hematology
Scottsdale, Arizona, United States
Arizona Cancer Center
Tucson, Arizona, United States
Desert Hematology Oncology
Rancho Mirage, California, United States
Southern California Permanente Medical Group
San Diego, California, United States
Pacific Hematology Oncology Associates
San Francisco, California, United States
George Washington University
Washington D.C., District of Columbia, United States
Lynn Cancer Institute Center For Hematology-Oncology
Boca Raton, Florida, United States
Baptist Cancer Institute
Jacksonville, Florida, United States
Mount Sinai Comprehensive Cancer Center
Miami Beach, Florida, United States
...and 124 more locations
Time frame: Randomization until pain progression, up to April 2015, approximately 57 months
Number of Participants Who Died or Had Adverse Events (AEs), Serious Adverse Events (SAEs), Immune-related AEs (irAEs), or Immune-mediated Adverse Reactions (imARs)
AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. irAE=AEs consistent with an immune mediated mechanism. imAR=AEs of special interest that were adjudicated as imAR by investigator. Treatment-related=having certain, probable, possible, or missing relationship to study drug. Grade (Gr) 1=Mild, Gr 2=Moderate, Gr 3=Severe, Gr 4= Potentially Life-threatening or disabling. Events were graded using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 3.0.
Time frame: Day 1 of study therapy to last dose plus 70 days
Number of Treated Participants With Grade 3 or 4 Clinical Laboratory Abnormalities
NCI CTC, Version 3 used to assess parameters. LLN=lower limit of normal. ULN=upper limit of normal. CTC criteria: White blood cells (WBC): Gr 3:\<2.0 to 1.0\*10\^9/L, Gr 4:\<1.0\*10\^9/L. Absolute neutrophil count (ANC): Gr 3:\<1.0 to 0.5\*10\^9/L, Gr 4:\<0.5\*10\^9/L. Platelet count: Gr 3:\<50.0 to 25.0\*10\^9/L, Gr 4:\<25.0 to 10\^9/L. Hemoglobin: Gr 3:\<8.0 to 6.5 g/dL, Gr 4:\<6.5 g/dL. Absolute Lymphocyte Count (ALC): Gr 3: 0.2 - \<0.5\*10\^9/L, Gr 4: \<0.2\*10\^9/L. Lipase: Gr 3:\> 2.0 - 5.0 \* ULN; Gr 4: \> 5.0 X ULN. Amylase: Gr 3: \> 2.0 - 5.0 \* ULN; Gr 4: \> 5.0 \* ULN. Alanine Aminotransferase (ALT) Gr 3: \> 5.0 - 20.0 \* ULN; Gr 4: \> 20.0 \* ULN. Aspartate Aminotransferase (AST): Gr 3: \> 5.0 - 20.0 \* ULN; Gr 4: \> 20.0 \* ULN. Bilirubin: Gr 3: \> 3.0 - 10.0 \* ULN; Gr 4: \> 10.0 \* ULN. Alkaline Phosphatase: Gr 3: \> 5.0 - 20.0 \* ULN; Gr 4: \> 20.0 \* ULN. Creatinine: Gr 3: \> 3.0-6.0 \* ULN, Gr 4: \>6.0 \* ULN.
Time frame: Randomization up to April 2015, approximately 57 months