Prostate Cancer
Conditions
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
Interventions
DRUGIpilimumab
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
DRUGPlacebo
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
Sponsors
Bristol-Myers Squibb
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com Inclusion Criteria: * Metastatic prostate cancer * Asymptomatic or minimally symptomatic * Progression during hormonal therapy * Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1
Exclusion criteria
* Liver, lung or brain metastases * Prior immunotherapy or chemotherapy for metastatic prostate cancer * Autoimmune disease * HIV, Hepatitis B, or Hepatitis C infection
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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). |
| 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. |
| 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. |
| 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. |
Countries
Argentina, Australia, Brazil, Canada, Chile, Colombia, Czechia, Denmark, France, Germany, Greece, Hungary, Italy, Mexico, Netherlands, Norway, Poland, Puerto Rico, Romania, Spain, Sweden, Turkey (Türkiye), United Kingdom, United States
Participant flow
Pre-assignment details
837 participants enrolled; 602 randomized; 598 treated. Of the 235 not randomized, 189 no longer met criteria, 28 withdrew consent, 2 suffered Adverse Events, 2 were non-compliant, 1 was lost to follow-up, and 13 were removed for other/unspecified reasons. Post-randomization, 4 no longer met criteria and were not treated (3 placebo, 1 ipilimumab)
Participants by arm
| Arm | Count |
|---|---|
| Placebo Placebo infusion (normal saline or 5% dextrose) 2mL/kg was administered intravenously (IV) over 90 minutes. Induction dosing occurred on Days 1, 22, 43, and 64 during the Induction phase and every 12 weeks starting at Week 24 during the Maintenance phase until unacceptable toxicity, clinical deterioration, confirmed disease progression, or study closure. | 202 |
| Ipilimumab Ipilimumab 10 mg/kg was administered intravenously (IV) over 90 minutes with a normal saline flush at the end. Induction dosing occurred on Days 1, 22, 43, and 64 during the Induction phase and every 12 weeks starting at Week 24 during the Maintenance phase until unacceptable toxicity, clinical deterioration, confirmed disease progression, or study closure. | 400 |
| Total | 602 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse event unrelated to study drug | 13 | 29 |
| Overall Study | Death | 2 | 12 |
| Overall Study | Disease progression | 156 | 197 |
| Overall Study | Maximum clinical benefit | 5 | 5 |
| Overall Study | No longer met study criteria | 0 | 1 |
| Overall Study | Other | 7 | 14 |
| Overall Study | Poor/non-compliance | 0 | 1 |
| Overall Study | Study drug toxicity | 5 | 114 |
| Overall Study | Withdrawal by Subject | 10 | 25 |
Baseline characteristics
| Characteristic | Placebo | Ipilimumab | Total |
|---|---|---|---|
| Age, Continuous | 68.6 years | 69.3 years | 69.0 years |
| Age, Customized < 65 years | 65 participants | 104 participants | 169 participants |
| Age, Customized >= 65 years | 137 participants | 296 participants | 433 participants |
| Region of Enrollment Australia | 24 participants | 33 participants | 57 participants |
| Region of Enrollment Europe | 74 participants | 161 participants | 235 participants |
| Region of Enrollment North America | 79 participants | 154 participants | 233 participants |
| Region of Enrollment South America | 25 participants | 52 participants | 77 participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 202 Participants | 400 Participants | 602 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 166 / 199 | 361 / 399 |
| serious Total, serious adverse events | 53 / 199 | 213 / 399 |
Outcome results
Primary
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
Population: All randomized participants
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Placebo | Overall Survival (OS) Time | 29.73 months |
| Ipilimumab | Overall Survival (OS) Time | 28.65 months |
p-value: 0.366795.87% CI: [0.88, 1.39]Log Rank
Secondary
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
Population: All treated participants
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Number of Participants Who Died or Had Adverse Events (AEs), Serious Adverse Events (SAEs), Immune-related AEs (irAEs), or Immune-mediated Adverse Reactions (imARs) | SAE (any grade) | 53 participants |
| Placebo | 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 leading to DC (grade 3-4) | 14 participants |
| Placebo | Number of Participants Who Died or Had Adverse Events (AEs), Serious Adverse Events (SAEs), Immune-related AEs (irAEs), or Immune-mediated Adverse Reactions (imARs) | Drug-related AE (grade 3-4) | 11 participants |
| Placebo | Number of Participants Who Died or Had Adverse Events (AEs), Serious Adverse Events (SAEs), Immune-related AEs (irAEs), or Immune-mediated Adverse Reactions (imARs) | irAE (any grade) | 57 participants |
| Placebo | Number of Participants Who Died or Had Adverse Events (AEs), Serious Adverse Events (SAEs), Immune-related AEs (irAEs), or Immune-mediated Adverse Reactions (imARs) | SAE (grade 3-4) | 39 participants |
| Placebo | Number of Participants Who Died or Had Adverse Events (AEs), Serious Adverse Events (SAEs), Immune-related AEs (irAEs), or Immune-mediated Adverse Reactions (imARs) | irAE (grade 3-4) | 3 participants |
| Placebo | Number of Participants Who Died or Had Adverse Events (AEs), Serious Adverse Events (SAEs), Immune-related AEs (irAEs), or Immune-mediated Adverse Reactions (imARs) | Drug-related AE (any grade) | 98 participants |
| Placebo | Number of Participants Who Died or Had Adverse Events (AEs), Serious Adverse Events (SAEs), Immune-related AEs (irAEs), or Immune-mediated Adverse Reactions (imARs) | imAR (grade >= 2) | 14 participants |
| Placebo | 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 leading to DC (any grade) | 20 participants |
| Placebo | Number of Participants Who Died or Had Adverse Events (AEs), Serious Adverse Events (SAEs), Immune-related AEs (irAEs), or Immune-mediated Adverse Reactions (imARs) | Deaths | 130 participants |
| Placebo | 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 (grade 3-4) | 59 participants |
| Ipilimumab | Number of Participants Who Died or Had Adverse Events (AEs), Serious Adverse Events (SAEs), Immune-related AEs (irAEs), or Immune-mediated Adverse Reactions (imARs) | Deaths | 259 participants |
| Ipilimumab | 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 (grade 3-4) | 223 participants |
| Ipilimumab | Number of Participants Who Died or Had Adverse Events (AEs), Serious Adverse Events (SAEs), Immune-related AEs (irAEs), or Immune-mediated Adverse Reactions (imARs) | Drug-related AE (any grade) | 325 participants |
| Ipilimumab | Number of Participants Who Died or Had Adverse Events (AEs), Serious Adverse Events (SAEs), Immune-related AEs (irAEs), or Immune-mediated Adverse Reactions (imARs) | Drug-related AE (grade 3-4) | 158 participants |
| Ipilimumab | Number of Participants Who Died or Had Adverse Events (AEs), Serious Adverse Events (SAEs), Immune-related AEs (irAEs), or Immune-mediated Adverse Reactions (imARs) | SAE (any grade) | 213 participants |
| Ipilimumab | Number of Participants Who Died or Had Adverse Events (AEs), Serious Adverse Events (SAEs), Immune-related AEs (irAEs), or Immune-mediated Adverse Reactions (imARs) | SAE (grade 3-4) | 153 participants |
| Ipilimumab | 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 leading to DC (any grade) | 139 participants |
| Ipilimumab | 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 leading to DC (grade 3-4) | 103 participants |
| Ipilimumab | Number of Participants Who Died or Had Adverse Events (AEs), Serious Adverse Events (SAEs), Immune-related AEs (irAEs), or Immune-mediated Adverse Reactions (imARs) | irAE (any grade) | 309 participants |
| Ipilimumab | Number of Participants Who Died or Had Adverse Events (AEs), Serious Adverse Events (SAEs), Immune-related AEs (irAEs), or Immune-mediated Adverse Reactions (imARs) | irAE (grade 3-4) | 125 participants |
| Ipilimumab | Number of Participants Who Died or Had Adverse Events (AEs), Serious Adverse Events (SAEs), Immune-related AEs (irAEs), or Immune-mediated Adverse Reactions (imARs) | imAR (grade >= 2) | 273 participants |
Secondary
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
Population: All treated participants with on-study laboratory results
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Number of Treated Participants With Grade 3 or 4 Clinical Laboratory Abnormalities | ANC (n=195;383) | 0 participants |
| Placebo | Number of Treated Participants With Grade 3 or 4 Clinical Laboratory Abnormalities | Hemoglobin (n=195;383) | 2 participants |
| Placebo | Number of Treated Participants With Grade 3 or 4 Clinical Laboratory Abnormalities | ALT (n=198;386) | 1 participants |
| Placebo | Number of Treated Participants With Grade 3 or 4 Clinical Laboratory Abnormalities | WBC (n=195;383) | 0 participants |
| Placebo | Number of Treated Participants With Grade 3 or 4 Clinical Laboratory Abnormalities | AST (n=196;383) | 1 participants |
| Placebo | Number of Treated Participants With Grade 3 or 4 Clinical Laboratory Abnormalities | ALC (n=195;383) | 4 participants |
| Placebo | Number of Treated Participants With Grade 3 or 4 Clinical Laboratory Abnormalities | Total Bilirubin (n=198;386) | 0 participants |
| Placebo | Number of Treated Participants With Grade 3 or 4 Clinical Laboratory Abnormalities | Platelet count (n=194;381) | 0 participants |
| Placebo | Number of Treated Participants With Grade 3 or 4 Clinical Laboratory Abnormalities | Alkaline phosphatase (n=196;383) | 11 participants |
| Placebo | Number of Treated Participants With Grade 3 or 4 Clinical Laboratory Abnormalities | Lipase (n=196;382) | 4 participants |
| Placebo | Number of Treated Participants With Grade 3 or 4 Clinical Laboratory Abnormalities | Creatinine (n=9;23) | 0 participants |
| Placebo | Number of Treated Participants With Grade 3 or 4 Clinical Laboratory Abnormalities | Amylase (n=198;385) | 2 participants |
| Ipilimumab | Number of Treated Participants With Grade 3 or 4 Clinical Laboratory Abnormalities | Creatinine (n=9;23) | 0 participants |
| Ipilimumab | Number of Treated Participants With Grade 3 or 4 Clinical Laboratory Abnormalities | WBC (n=195;383) | 3 participants |
| Ipilimumab | Number of Treated Participants With Grade 3 or 4 Clinical Laboratory Abnormalities | ANC (n=195;383) | 2 participants |
| Ipilimumab | Number of Treated Participants With Grade 3 or 4 Clinical Laboratory Abnormalities | Platelet count (n=194;381) | 2 participants |
| Ipilimumab | Number of Treated Participants With Grade 3 or 4 Clinical Laboratory Abnormalities | Hemoglobin (n=195;383) | 5 participants |
| Ipilimumab | Number of Treated Participants With Grade 3 or 4 Clinical Laboratory Abnormalities | ALC (n=195;383) | 12 participants |
| Ipilimumab | Number of Treated Participants With Grade 3 or 4 Clinical Laboratory Abnormalities | Lipase (n=196;382) | 27 participants |
| Ipilimumab | Number of Treated Participants With Grade 3 or 4 Clinical Laboratory Abnormalities | Amylase (n=198;385) | 9 participants |
| Ipilimumab | Number of Treated Participants With Grade 3 or 4 Clinical Laboratory Abnormalities | ALT (n=198;386) | 16 participants |
| Ipilimumab | Number of Treated Participants With Grade 3 or 4 Clinical Laboratory Abnormalities | AST (n=196;383) | 18 participants |
| Ipilimumab | Number of Treated Participants With Grade 3 or 4 Clinical Laboratory Abnormalities | Total Bilirubin (n=198;386) | 4 participants |
| Ipilimumab | Number of Treated Participants With Grade 3 or 4 Clinical Laboratory Abnormalities | Alkaline phosphatase (n=196;383) | 18 participants |
Secondary
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
Population: All randomized participants
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Placebo | Progression-Free Survival (PFS) Time | 3.81 months |
| Ipilimumab | Progression-Free Survival (PFS) Time | 5.59 months |
95% CI: [0.55, 0.8]
Secondary
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.
Time frame: Randomization until pain progression, up to April 2015, approximately 57 months
Population: All randomized participants
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Placebo | Time to Pain Progression | 16.62 months |
| Ipilimumab | Time to Pain Progression | 21.68 months |
95.87% CI: [0.71, 1.35]
Secondary
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
Population: All randomized participants who received subsequent non-hormonal cytotoxic therapy
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Placebo | Time to Subsequent Non-hormonal Cytotoxic Therapy | 10.91 months |
| Ipilimumab | Time to Subsequent Non-hormonal Cytotoxic Therapy | 18.04 months |
95.87% CI: [0.52, 0.83]