Phase 3 Study of Immunotherapy to Treat Advanced Prostate Cancer
- Registration Number
- NCT01057810
- Lead Sponsor
- Bristol-Myers Squibb
- Brief Summary
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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 837
- Metastatic prostate cancer
- Asymptomatic or minimally symptomatic
- Progression during hormonal therapy
- Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1
- Liver, lung or brain metastases
- Prior immunotherapy or chemotherapy for metastatic prostate cancer
- Autoimmune disease
- HIV, Hepatitis B, or Hepatitis C infection
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo - Ipilimumab Ipilimumab -
- Primary Outcome Measures
Name Time Method Overall Survival (OS) Time Randomization until death from any cause, up to April 2015, approximately 57 months 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.
- Secondary Outcome Measures
Name Time Method Progression-Free Survival (PFS) Time Randomization until disease progression, up to April 2015, approximately 57 months 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.
Number of Treated Participants With Grade 3 or 4 Clinical Laboratory Abnormalities Randomization up to April 2015, approximately 57 months 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 to Pain Progression Randomization until pain progression, up to April 2015, approximately 57 months 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.Time to Subsequent Non-hormonal Cytotoxic Therapy Randomization until subsequent non-hormonal cytotoxic therapy, up to April 2015, approximately 57 months 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).
Number of Participants Who Died or Had Adverse Events (AEs), Serious Adverse Events (SAEs), Immune-related AEs (irAEs), or Immune-mediated Adverse Reactions (imARs) Day 1 of study therapy to last dose plus 70 days 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.
Trial Locations
- Locations (44)
Sidney Kimmel Comprehensive Cancer Center At Johns Hopkins
🇺🇸Baltimore, Maryland, United States
Baptist Cancer Institute
🇺🇸Jacksonville, Florida, United States
Md Anderson Cancer Center Orlando
🇺🇸Orlando, Florida, United States
Carolina Urologic Research Center
🇺🇸Myrtle Beach, South Carolina, United States
Lynn Cancer Institute Center For Hematology-Oncology
🇺🇸Boca Raton, Florida, United States
Hematology Oncology Associates Of The Treasure Coast
🇺🇸Port Saint Lucie, Florida, United States
George Washington University
🇺🇸Washington, District of Columbia, United States
North Shore Hematology/Oncology Associates, P.C.
🇺🇸East Setauket, New York, United States
Tulsa Cancer Institute
🇺🇸Tulsa, Oklahoma, United States
Mount Sinai Comprehensive Cancer Center
🇺🇸Miami Beach, Florida, United States
Scott & White Memorial Hospital And Clinic
🇺🇸Temple, Texas, United States
Cancer Care Specialists Of Central Illinois
🇺🇸Decatur, Illinois, United States
Georgia Regents University
🇺🇸Augusta, Georgia, United States
Va Caribbean Healthcare System
🇵🇷San Juan, Puerto Rico
Northside Hospital
🇺🇸Atlanta, Georgia, United States
Stony Brook University Medical Center
🇺🇸Stony Brook, New York, United States
Goshen Center For Cancer Care
🇺🇸Goshen, Indiana, United States
Gwinnett Hospital System Inc.
🇺🇸Lawrenceville, Georgia, United States
University Of Maryland
🇺🇸Baltimore, Maryland, United States
Local Institution
🇬🇧Birmingham, West Midlands, United Kingdom
Suny Upstate Medical University
🇺🇸Syracuse, New York, United States
University Of Chicago
🇺🇸Chicago, Illinois, United States
St. Luke'S Hospital & Health Network Laboratory
🇺🇸Bethlehem, Pennsylvania, United States
Cancer Center Of The Carolinas
🇺🇸Greenville, South Carolina, United States
Nevada Cancer Institute
🇺🇸Las Vegas, Nevada, United States
Southern California Permanente Medical Group
🇺🇸San Diego, California, United States
Comprehensive Cancer Centers Of Nevada
🇺🇸Las Vegas, Nevada, United States
Utah Cancer Specialists
🇺🇸Salt Lake City, Utah, United States
Straub Clinic And Hospital
🇺🇸Honolulu, Hawaii, United States
Hutchinson Clinic, Pa
🇺🇸Hutchinson, Kansas, United States
Cancer Center Of Kansas
🇺🇸Wichita, Kansas, United States
Mayo Clinic
🇺🇸Rochester, Minnesota, United States
Kaiser Permanente Oncology/Hematology
🇺🇸Portland, Oregon, United States
Oregon Health & Science University
🇺🇸Portland, Oregon, United States
Novant Health Oncology Specialists
🇺🇸Winston Salem, North Carolina, United States
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
Pacific Hematology Oncology Associates
🇺🇸San Francisco, California, United States
Kansas City Veterans Affairs Medical Center
🇺🇸Kansas City, Missouri, United States
Goshen Medical Associates
🇺🇸Goshen, New York, United States
Providence Regional Medical Center Everett
🇺🇸Everett, Washington, United States
Montefiore Medical Center
🇺🇸Bronx, New York, United States