Neoplasm Metastasis, Prostate Cancer
Conditions
Keywords
Prostate Cancer, Oncology, Prostate, Cancer, Metastatic, Hormone, PSA, Metastatic Hormone-Refractory Prostate Cancer (HRPC)
Brief summary
Multicenter study in which patients with metastatic hormone refractory prostate cancer (HRPC), who have not had previous chemotherapy or immunotherapy treatments, received MDX-010 every 3 weeks for 4 doses (12 weeks total duration of induction). MDX-010 was administered at escalating dosage levels of 3, 5, and 10 mg/kg/dose infusions. At least 6 patients were to be enrolled in each dosage level. Patients who tolerated and responded to treatment or who had stable disease for 3 months or longer and who subsequently progressed during the follow up phase of the study had the option to receive additional treatment with MDX-010, up to 4 cycles. Patients were followed in the study for response up to 2 years and were followed for survival status for up to 5 years after enrollment.
Interventions
DRUGMDX-010
selected dose administered IV every 3 weeks
Sponsors
Bristol-Myers Squibb
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Histologic diagnosis of adenocarcinoma of the prostate * Metastatic prostate cancer (positive bone scan or measurable disease) * Total testosterone of less than 50 ng/dL, except for patients with prior orchiectomy, where testosterone does not need to be measured. * Patients who are receiving an antiandrogen as part of primary androgen ablation must demonstrate disease progression following discontinuation of antiandrogen and completion of a washout period and then observe disease progression. * Patients must stop using any herbal product known to decrease PSA levels (eg., saw palmetto and PC-SPES) or any systemic or topical corticosteroid at least 4 weeks prior to screening. Progressive disease must be documented after discontinuation of these products. * Progressive disease after androgen deprivation (or hormone therapy). For patients with measurable disease, progression will be defined by Response Evaluation Criteria in Solid Tumors (RECIST) criteria. For patients with progression in, or without any measurable disease, a positive bone scan and elevated PSA will be required. * Patients receiving bisphosphate therapy must have been on stable doses for at least 4 weeks with stable symptoms prior to enrollment. * No prior chemotherapy or immunotherapy (tumor vaccine, cytokine, or growth factor given to control prostate cancer). * Prior radiation therapy completed at least 4 weeks prior to enrollment. No prior radiopharmaceuticals (strontium, samarium) within 8 weeks prior to enrollment.
Exclusion criteria
* Bone pain due to metastatic bone disease severe enough to require routine narcotic analgesic use. * History of severe hypersensitivity reactions to drugs formulated with polysorbate 80. * Patients with active autoimmune disease or a history of autoimmune disease that required systemic steroids or immunosuppressive medications, except for patients with vitiligo. * Prior therapy with any anti-cytotoxic T-lymphocyte antigen 4 (anti-CTLA-4) antibody. * Active infection requiring therapy. * Concurrent medical condition requiring the use of systemic or topical corticosteroids; systemic or topical corticosteroids must be discontinued at least 4 weeks prior to enrollment. The use of inhaled corticosteroids is acceptable.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Serious AEs (SAEs), Adverse Events (AEs) Leading to Discontinuation, and Immune-related AEs - Treated Participants | Day 1 to last day of study treatment (+70 days) up to 2 years | AEs graded using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0. 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. Grade (Gr) 1=Mild, Gr 2=Moderate, Gr 3=Severe, Gr 4= Potentially Life-threatening or disabling, Gr 5=Death. Related=relationship to study drug reported as certain, probable, possible, or missing. Immune-related AE (irAE) was defined as a clinically significant AE of any organ that is associated with drug exposure, of unknown etiology, and is consistent with an immune-mediated mechanism. Day 1=first day of study treatment. |
| Number of Participants With Best PSA Response at Day 85 by Category - PSA Evaluable Participants | Day 85 | Response by investigator using National Cancer Institute (NCI) PSA Working Group recommendations= PSA \< 50% of PSA reference value occurring on or before Day 85; response confirmed at least 4 weeks after the first measurement. PSA reference=PSA measured immediately prior to treatment. Complete response (CR)=PSA \< 2 nanograms per milliliter (ng/mL), confirmed at least 4 weeks after 1st value; Partial response (PR)=PSA ≤ 50% of PSA reference, confirmed at least 4 weeks after 1st value; Unconfirmed=not confirmed by repeat measurements; Stable disease(SD)=No change from PSA reference; Progressive disease (PD) defined: If PSA nadir was ≥ 100% of the reference: PSA ≥ 125% of PSA reference and with a difference of absolute value of ≥ 5 ng/mL; If PSA nadir was \< 100% and ≥ 50% of the reference: PSA ≥ 125% of PSA nadir and with a difference of absolute value of ≥ 5 ng/mL: If PSA nadir was \< 50% of the reference: PSA ≥ 150% of PSA nadir and with a difference of absolute value of ≥ 5 ng/mL. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to PSA Response at Day 85 in Participants With Complete Response (CR) or Confirmed Partial Response (PR) at Day 85 | Day 1 to Day 85 | Time to PSA response was measured in months. Time to PSA response was analyzed in those participants with CR or PR at Day 85. CR=PSA concentration \< 2 ng/mL, confirmed at least 4 weeks after 1st value; PR=PSA concentration ≤ 50% of PSA reference, confirmed at least 4 weeks after 1st value. |
| Overall Tumor Response Rate in 10 mg/kg Ipilimumab Monotherapy and Ipilimumab/XRT Combination Therapy | Day 1 to last day of study treatment (+70 days) up to 2 years | Tumor response rate was defined as the number of participants with a best response of partial or complete response divided by the total number of tumor evaluable participants. Overall Tumor Response was defined as participants with a tumor response of CR or PR at anytime during the study. CR=Disappearance of all target lesions; PR=At least a 30% decrease in the sum of the longest diameter (LD) of target lesions taking as reference, baseline sum LD. For a status of CR or PR, changes in tumor measurements were confirmed by repeat studies no less than 4 weeks after the criteria for response were first met |
| PSA Response Rate at Day 85 and Overall PSA Response Rate in 10 mg/kg Monotherapy and Combination Therapy | Day 85, Day 1 to last day of study treatment (+70 days) up to 2 years | PSA response rate was defined as the number of participants with a PSA response (PR or CR) divided by the total number of PSA evaluable participants. PSA response at Day 85, as reported by the investigator, was defined as a PSA concentration \< 50% of the PSA reference value occurring on or before Day 85 and this response was confirmed at least 4 weeks after the first determination. The PSA reference value was the PSA concentration measured immediately prior to treatment. Overall Response is \< 50% of the PSA reference value occurring anytime after treatment was initiated and this response was confirmed at least 4 weeks after the first determination. Complete response=PSA concentration \< 2 ng/mL, confirmed at least 4 weeks after first value; Partial response=PSA concentration ≤ 50% of PSA reference value, confirmed at least 4 weeks after first determination. |
| Number of Participants Who Died by Date of Primary Analysis and by Date of Completion of Follow Up - All Treated Participants | Day 1 to 5 years post treatment | Primary analysis was conducted on data from Day 1 up to 2 years post treatment, data available as of September 2009. Final Follow-Up analysis was conducted on data up to 5 years post treatment, data available as of September 2013 (minimum time of eligibility 54 months to a maximum of 85 months). Primary causes of deaths are listed under each timepoint. |
| Number of Participants With Best Overall PSA Response by Category - PSA Evaluable Participants | Day 1 to last day of study treatment (+70 days) up to 2 years | Best Overall PSA response per investigator, using NCI PSA Working Group: PSA with CR or PR at any time after treatment initiation and was confirmed at least 4 weeks after the first measurement. PSA reference=PSA measured immediately prior to treatment. CR=PSA concentration \< 2 nanograms per milliliter (ng/mL), confirmed at least 4 weeks after 1st value; PR=PSA concentration ≤ 50% of PSA reference, confirmed at least 4 weeks after 1st value; Unconfirmed=not confirmed by repeat measurements; SD=No change from PSA reference value; PD = If PSA nadir was ≥ 100% of the reference value: PSA ≥ 125% of PSA reference and with a difference of absolute value of ≥ 5 ng/mL; If PSA nadir was \< 100% and ≥ 50% of the reference value: PSA ≥ 125% of PSA nadir and with a difference of absolute value of ≥ 5 ng/mL: If PSA nadir was \< 50% of the reference value: PSA ≥ 150% of PSA nadir and with a difference of absolute value of ≥ 5 ng/mL. |
| Number of Participants With On-Study Hematology Laboratory Tests Worst Common Terminology Criteria (CTC) Grade - Treated Participants | Day 1 to last day of study treatment (+70 days) up to 2 years | NCI CTC version(v) 3.0 was used to determine Grade (Gr). Screening was Day -28 to Day -1. On-study laboratories were reported after the first dose date, every 21 days during a treatment cycle, and within 70 days of last dose of study therapy (ie, Days 1, 22, 43, 64, 85, etc). Hemoglobin grams per liter (g/L): Gr 1: 10.0 - less than (\<) lower limit of normal (LLN); Gr 2: 8.0 - \< 10.0; Gr 3: 6.5 - \< 8.0; Gr 4: \< 6.5. White blood cells(WBC) 10\^9 cells per liter (c/L): Gr1: 3.0 - \< LLN; Gr 2: 2.0 - \< 3.0; Gr 3: 1.0 - \< 2.0; Gr4: \< 1.0. Lymphocytes (absolute) 10\^9 c/L: Gr1: 0.8 - \< 1.5; Gr 2: 0.5 - \< 0.8; Gr 3): 0.2 - \< 0.5; Gr 4: \< 0.2. Neutrophils (absolute) 10\^9 c/L: Gr 1: 1.5 - \< 2.0; Gr 2: 1.0 - \< 1.5; Gr 3: 0.5 - \< 1.0; Gr 4: \< 0.5. Platelets 10\^9 c/L: Gr 1: 75.0 - \< lower limits of normal (LLN); Gr 2: 50.0 - \< 75.0; Gr 3: 25.0 - \< 50.0; Gr 4: \< 25.0. |
| Number of Participants With On-Study Serum Chemistry Laboratory Tests Worst Common Terminology Criteria (CTC) Grade - Treated Participants | Day 1 to last day of study treatment (+70 days) up to 2 years | CTC v3.0 used. On-study serum chemistry laboratories were reported after first dose date, every 21 days during a treatment cycle, and within 70 days of last dose of study therapy (ie, Days 1, 22, 43, 64, 85, etc). Alanine Aminotransferase (ALT) Units per Liter (U/L) Gr 1: \> 1.0 - 2.5 \* upper limits of normal (ULN); Gr 2: \> 2.5 - 5.0 \* ULN; Gr 3: \> 5.0 - 20.0 \* ULN; Gr 4: \> 20.0 \* ULN. Aspartate Aminotransferase (AST) U/L: Gr 1: \> 1.0 - 2.5 \* ULN; Gr 2: \> 2.5 - 5.0 \* ULN; Gr 3: \> 5.0 - 20.0 \* ULN; Gr 4: \> 20.0 \* ULN. Total Bilirubin micromoles per liter (µmol/L): Gr 1: \> 1.0 - 1.5 \* ULN; Gr 2: \> 1.5 - 3.0 \* ULN; Gr 3: \> 3.0 - 10.0 \* ULN; Gr 4: \> 10.0 \* ULN. Alkaline Phosphatase U/L: Gr 1: \> 1.0 - 2.5 \* ULN; Gr 2: \> 2.5 - 5.0 \* ULN; Gr 3: \> 5.0 - 20.0 \* ULN; Gr 4: \> 20.0 \* ULN. Amylase U/L: Gr1: \> 1.0 - 1.5 \* ULN; Gr 2: \> 1.5 - 2.0 \* ULN; Gr 3: \> 2.0 - 5.0 \* ULN; Gr4: \> 5.0 \* ULN. Creatinine µmol/L: Gr1: \> 1.0 - 1.5\*ULN; Gr2: \> 1.5 - 3.0\*ULN; Gr3: \> 3.0 - 6.0\*ULN; Gr4: \> 6.0\*ULN. |
| Number of Participants With Clinically Significant Electrocardiogram (ECG) Abnormalities at Baseline and During Treatment Period - Treated Participants | Baseline up to 2 years | 12 Lead Electrocardiograms (ECGs) were performed at screening (Day -28 to Day -1), and on Day 85 during a treatment cycle, and at the end of treatment period. Clinically significant abnormalities could include atrial fibrillation, anterior fascicular block, marked sinus bradycardia, possible lateral infarct, and T-wave abnormality (other potential abnormalities were not excluded from consideration). |
| Number of Participants Positive for Human Anti-Human Antibodies (HAHA) - Treated Participants | Day 1 up to 2 years | HAHA was measured by electrochemiluminescent (ECL) immunoassay for the detection of antibodies in human heparin plasma. Testing was performed on Days 1 (prior to ipilimumab infusion), 64, 85, and at completion of treatment. |
| Overall Survival at Completion of Follow Up Period - Treated Participants | Day 1 to 5 years post treatment | Overall Survival (OS) was defined as the time from the first date of study treatment until the date of death and was measured in months. For those participants who have not died, OS was censored at the last date the participant was known to be alive. Completion of follow-up for OS was a minimum time of eligibility 54 months to a maximum of 85 months. |
| Number of Participants With Best Overall Tumor Response by Category - Tumor Evaluable Participants | Day 1 to last day of study treatment (+70 days) up to 2 years | For those with measurable disease, tumor response based upon tumor lesions (per investigator) using Response Evaluation Criteria in Solid Tumors (RECIST). Best Overall=Participants with a best tumor response of CR or PR at anytime during the study. CR=Disappearance of all target lesions; PR=At least a 30% decrease in the sum of the longest diameter (LD) of target lesions taking as reference, baseline sum LD. For a status of CR or PR, changes in tumor measurements were confirmed by repeat studies no less than 4 weeks after the criteria for response were first met; Unconfirmed=not confirmed by repeat measurements; SD=Neither sufficient decrease to qualify for PR nor sufficient increase to qualify for progressive disease (PD), taking as reference the smallest sum LD since the treatment started; PD=At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. |
Countries
United States
Participant flow
Recruitment details
Study initiated January 2006; Primary endpoint last visit September 2009; follow up period last visit July 2013 with data cut off September 2013. Male patients with castrate-resistant prostate cancer (CRPC) who met study criteria were enrolled.
Pre-assignment details
75 participants enrolled and were assigned to treatment; 71 were treated. Reasons for the 4 participants not receiving treatment were not specified by the investigators. Ipilimumab was administered at escalating dosage levels of 3, 5, and 10 mg/kg/dose.
Participants by arm
| Arm | Count |
|---|---|
| Ipilimumab Monotherapy 3 mg/kg A single dose of 3 mg/kg ipilimumab was administered over 90 minutes intravenously (IV) on Days 1, 22, 43, and 64 for a total of 4 doses in the induction period. Those participants with a clinical response of stable disease (SD) or conflicting disease response assessment (CDRA) at the end of induction period could have received additional treatment up to a total of 16 doses in the maintenance period. The length of time on study for an individual could be up to 2 years. Follow up for survival status was for up to 5 years after enrollment. | 8 |
| Ipilimumab Monotherapy 5 mg/kg A single dose of 5 mg/kg ipilimumab was administered over 90 minutes IV on Days 1, 22, 43, and 64 for a total of 4 doses (induction). Those participants with a clinical response of SD or CDRA at the end of induction could have received additional treatment up to a total of 16 doses in the maintenance period. The length of time on study for an individual could be up to 2 years. Follow up for survival status was for up to 5 years after enrollment. | 6 |
| Ipilimumab Monotherapy 10 mg/kg A single dose of 10 mg/kg ipilimumab was administered over 90 minutes IV on Days 1, 22, 43, and 64 for a total of 4 doses in the induction period. Those participants with a clinical response of SD or CDRA at the end of induction could have received additional treatment up to a total of 16 doses in the maintenance period. The length of time on study for an individual could be up to 2 years. Follow up for survival status was for up to 5 years after enrollment. | 16 |
| Ipilimumab 3 mg/kg + XRT Combination Therapy A single dose of 3 mg/kg ipilimumab was administered over 90 minutes IV on Days 1, 22, 43, and 64 for a total of 4 doses in the induction period. In addition, participants received a single dose of 800 rads (8 Gray) of focal radiotherapy (XRT) to each target lesion within 48 hours before the first infusion of ipilimumab during the induction period. According to RECIST, target or measurable lesions were defined as lesions that could be accurately measured in at least one dimension (longest diameter recorded) as ≥ 10 mm with spiral computed tomography (CT). Those participants with a clinical response of SD or CDRA at the end of induction could have received additional treatment up to a total 16 doses in the maintenance period. Radiotherapy was not administered during maintenance period. The length of time on study for an individual could be up to 2 years. Follow up for survival status was for up to 5 years after enrollment. | 7 |
| Ipilimumab 10 mg/kg + XRT Combination A single dose of 10 mg/kg ipilimumab was administered over 90 minutes IV on Days 1, 22, 43, and 64 for a total of 4 doses in the induction period. In addition, participants received a single dose of 800 rads (8 Gray) of focal XRT to each target lesion within 48 hours before the first infusion of ipilimumab in the induction period. According to RECIST, target or measurable lesions were defined as lesions that could be accurately measured in at least one dimension (longest diameter recorded) as ≥ 10 mm with spiral CT. Those participants with a clinical response of SD or CDRA at the end of induction period could have received additional treatment up to a total of 16 doses in the maintenance period. Radiotherapy was not administered during maintenance period. The length of time on study for an individual could be up to 2 years. Follow up for survival status was for up to 5 years after enrollment. | 34 |
| Total | 71 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 |
|---|---|---|---|---|---|---|
| Overall Study | Adverse Event | 2 | 1 | 1 | 1 | 3 |
| Overall Study | Death | 0 | 1 | 1 | 0 | 5 |
| Overall Study | Disease Progression | 6 | 4 | 10 | 5 | 22 |
| Overall Study | Lost to Follow-up | 0 | 0 | 1 | 0 | 1 |
| Overall Study | Other | 0 | 0 | 0 | 1 | 1 |
Baseline characteristics
| Characteristic | Ipilimumab Monotherapy 3 mg/kg | Total | Ipilimumab 10 mg/kg + XRT Combination | Ipilimumab 3 mg/kg + XRT Combination Therapy | Ipilimumab Monotherapy 10 mg/kg | Ipilimumab Monotherapy 5 mg/kg |
|---|---|---|---|---|---|---|
| Age, Continuous | 68.0 years STANDARD_DEVIATION 8.1 | 65.4 years STANDARD_DEVIATION 8.5 | 65.7 years STANDARD_DEVIATION 9.1 | 67.6 years STANDARD_DEVIATION 8.5 | 65.2 years STANDARD_DEVIATION 7.7 | 58.2 years STANDARD_DEVIATION 5.6 |
| Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) ECOG PS 0 | 5 participants | 33 participants | 9 participants | 4 participants | 10 participants | 5 participants |
| Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) ECOG PS 1 | 3 participants | 34 participants | 22 participants | 2 participants | 6 participants | 1 participants |
| Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) ECOG PS 2 | 0 participants | 1 participants | 0 participants | 1 participants | 0 participants | 0 participants |
| Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) ECOG PS Not Reported | 0 participants | 3 participants | 3 participants | 0 participants | 0 participants | 0 participants |
| Mean Prostate-Specific Antigen (PSA) in ng/mL | 121.6 ng/mL STANDARD_DEVIATION 140.2 | 212.9 ng/mL STANDARD_DEVIATION 346.5 | 250.1 ng/mL STANDARD_DEVIATION 324.1 | 66.6 ng/mL STANDARD_DEVIATION 68.1 | 302.7 ng/mL STANDARD_DEVIATION 521.2 | 48.8 ng/mL STANDARD_DEVIATION 43.9 |
| Race/Ethnicity, Customized Asian | 0 participants | 1 participants | 1 participants | 0 participants | 0 participants | 0 participants |
| Race/Ethnicity, Customized Black | 0 participants | 4 participants | 3 participants | 1 participants | 0 participants | 0 participants |
| Race/Ethnicity, Customized White | 8 participants | 66 participants | 30 participants | 6 participants | 16 participants | 6 participants |
| Region of Enrollment United States | 8 participants | 71 participants | 34 participants | 7 participants | 16 participants | 6 participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 8 Participants | 71 Participants | 34 Participants | 7 Participants | 16 Participants | 6 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk |
|---|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 8 / 8 | 6 / 6 | 16 / 16 | 6 / 7 | 33 / 34 |
| serious Total, serious adverse events | 3 / 8 | 2 / 6 | 9 / 16 | 2 / 7 | 19 / 34 |
Outcome results
Primary
Number of Participants With Best PSA Response at Day 85 by Category - PSA Evaluable Participants
Response by investigator using National Cancer Institute (NCI) PSA Working Group recommendations= PSA \< 50% of PSA reference value occurring on or before Day 85; response confirmed at least 4 weeks after the first measurement. PSA reference=PSA measured immediately prior to treatment. Complete response (CR)=PSA \< 2 nanograms per milliliter (ng/mL), confirmed at least 4 weeks after 1st value; Partial response (PR)=PSA ≤ 50% of PSA reference, confirmed at least 4 weeks after 1st value; Unconfirmed=not confirmed by repeat measurements; Stable disease(SD)=No change from PSA reference; Progressive disease (PD) defined: If PSA nadir was ≥ 100% of the reference: PSA ≥ 125% of PSA reference and with a difference of absolute value of ≥ 5 ng/mL; If PSA nadir was \< 100% and ≥ 50% of the reference: PSA ≥ 125% of PSA nadir and with a difference of absolute value of ≥ 5 ng/mL: If PSA nadir was \< 50% of the reference: PSA ≥ 150% of PSA nadir and with a difference of absolute value of ≥ 5 ng/mL.
Time frame: Day 85
Population: PSA-evaluable participants, including all participants in cohorts with monotherapy and with radiotherapy who received any ipilimumab and had a baseline PSA, were analyzed.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Ipilimumab Monotherapy 3 mg/kg | Number of Participants With Best PSA Response at Day 85 by Category - PSA Evaluable Participants | Unconfirmed Partial Response | 0 participants |
| Ipilimumab Monotherapy 3 mg/kg | Number of Participants With Best PSA Response at Day 85 by Category - PSA Evaluable Participants | Complete Response | 0 participants |
| Ipilimumab Monotherapy 3 mg/kg | Number of Participants With Best PSA Response at Day 85 by Category - PSA Evaluable Participants | Partial Response | 1 participants |
| Ipilimumab Monotherapy 3 mg/kg | Number of Participants With Best PSA Response at Day 85 by Category - PSA Evaluable Participants | Stable Disease | 4 participants |
| Ipilimumab Monotherapy 3 mg/kg | Number of Participants With Best PSA Response at Day 85 by Category - PSA Evaluable Participants | Progressive Disease | 3 participants |
| Ipilimumab Monotherapy 3 mg/kg | Number of Participants With Best PSA Response at Day 85 by Category - PSA Evaluable Participants | Unknown | 0 participants |
| Ipilimumab Monotherapy 5 mg/kg | Number of Participants With Best PSA Response at Day 85 by Category - PSA Evaluable Participants | Progressive Disease | 1 participants |
| Ipilimumab Monotherapy 5 mg/kg | Number of Participants With Best PSA Response at Day 85 by Category - PSA Evaluable Participants | Partial Response | 1 participants |
| Ipilimumab Monotherapy 5 mg/kg | Number of Participants With Best PSA Response at Day 85 by Category - PSA Evaluable Participants | Complete Response | 0 participants |
| Ipilimumab Monotherapy 5 mg/kg | Number of Participants With Best PSA Response at Day 85 by Category - PSA Evaluable Participants | Unconfirmed Partial Response | 0 participants |
| Ipilimumab Monotherapy 5 mg/kg | Number of Participants With Best PSA Response at Day 85 by Category - PSA Evaluable Participants | Stable Disease | 4 participants |
| Ipilimumab Monotherapy 5 mg/kg | Number of Participants With Best PSA Response at Day 85 by Category - PSA Evaluable Participants | Unknown | 0 participants |
| Ipilimumab Monotherapy 10 mg/kg | Number of Participants With Best PSA Response at Day 85 by Category - PSA Evaluable Participants | Stable Disease | 7 participants |
| Ipilimumab Monotherapy 10 mg/kg | Number of Participants With Best PSA Response at Day 85 by Category - PSA Evaluable Participants | Progressive Disease | 3 participants |
| Ipilimumab Monotherapy 10 mg/kg | Number of Participants With Best PSA Response at Day 85 by Category - PSA Evaluable Participants | Complete Response | 1 participants |
| Ipilimumab Monotherapy 10 mg/kg | Number of Participants With Best PSA Response at Day 85 by Category - PSA Evaluable Participants | Unconfirmed Partial Response | 2 participants |
| Ipilimumab Monotherapy 10 mg/kg | Number of Participants With Best PSA Response at Day 85 by Category - PSA Evaluable Participants | Partial Response | 2 participants |
| Ipilimumab Monotherapy 10 mg/kg | Number of Participants With Best PSA Response at Day 85 by Category - PSA Evaluable Participants | Unknown | 1 participants |
| Ipilimumab 3 mg/kg + XRT Combination Therapy | Number of Participants With Best PSA Response at Day 85 by Category - PSA Evaluable Participants | Stable Disease | 4 participants |
| Ipilimumab 3 mg/kg + XRT Combination Therapy | Number of Participants With Best PSA Response at Day 85 by Category - PSA Evaluable Participants | Partial Response | 0 participants |
| Ipilimumab 3 mg/kg + XRT Combination Therapy | Number of Participants With Best PSA Response at Day 85 by Category - PSA Evaluable Participants | Unconfirmed Partial Response | 0 participants |
| Ipilimumab 3 mg/kg + XRT Combination Therapy | Number of Participants With Best PSA Response at Day 85 by Category - PSA Evaluable Participants | Unknown | 0 participants |
| Ipilimumab 3 mg/kg + XRT Combination Therapy | Number of Participants With Best PSA Response at Day 85 by Category - PSA Evaluable Participants | Progressive Disease | 2 participants |
| Ipilimumab 3 mg/kg + XRT Combination Therapy | Number of Participants With Best PSA Response at Day 85 by Category - PSA Evaluable Participants | Complete Response | 0 participants |
| Ipilimumab 10 mg/kg + XRT Combination | Number of Participants With Best PSA Response at Day 85 by Category - PSA Evaluable Participants | Progressive Disease | 11 participants |
| Ipilimumab 10 mg/kg + XRT Combination | Number of Participants With Best PSA Response at Day 85 by Category - PSA Evaluable Participants | Unknown | 4 participants |
| Ipilimumab 10 mg/kg + XRT Combination | Number of Participants With Best PSA Response at Day 85 by Category - PSA Evaluable Participants | Unconfirmed Partial Response | 1 participants |
| Ipilimumab 10 mg/kg + XRT Combination | Number of Participants With Best PSA Response at Day 85 by Category - PSA Evaluable Participants | Partial Response | 3 participants |
| Ipilimumab 10 mg/kg + XRT Combination | Number of Participants With Best PSA Response at Day 85 by Category - PSA Evaluable Participants | Stable Disease | 14 participants |
| Ipilimumab 10 mg/kg + XRT Combination | Number of Participants With Best PSA Response at Day 85 by Category - PSA Evaluable Participants | Complete Response | 1 participants |
Primary
Number of Participants With Serious AEs (SAEs), Adverse Events (AEs) Leading to Discontinuation, and Immune-related AEs - Treated Participants
AEs graded using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0. 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. Grade (Gr) 1=Mild, Gr 2=Moderate, Gr 3=Severe, Gr 4= Potentially Life-threatening or disabling, Gr 5=Death. Related=relationship to study drug reported as certain, probable, possible, or missing. Immune-related AE (irAE) was defined as a clinically significant AE of any organ that is associated with drug exposure, of unknown etiology, and is consistent with an immune-mediated mechanism. Day 1=first day of study treatment.
Time frame: Day 1 to last day of study treatment (+70 days) up to 2 years
Population: All participants in the study who received either ipilimumab or radiation were analyzed.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Ipilimumab Monotherapy 3 mg/kg | Number of Participants With Serious AEs (SAEs), Adverse Events (AEs) Leading to Discontinuation, and Immune-related AEs - Treated Participants | irAE (Any Grade) | 6 participants |
| Ipilimumab Monotherapy 3 mg/kg | Number of Participants With Serious AEs (SAEs), Adverse Events (AEs) Leading to Discontinuation, and Immune-related AEs - Treated Participants | AEs leading to discontinuation | 2 participants |
| Ipilimumab Monotherapy 3 mg/kg | Number of Participants With Serious AEs (SAEs), Adverse Events (AEs) Leading to Discontinuation, and Immune-related AEs - Treated Participants | Grade 3-4 irAE | 1 participants |
| Ipilimumab Monotherapy 3 mg/kg | Number of Participants With Serious AEs (SAEs), Adverse Events (AEs) Leading to Discontinuation, and Immune-related AEs - Treated Participants | Drug-Related SAE | 2 participants |
| Ipilimumab Monotherapy 3 mg/kg | Number of Participants With Serious AEs (SAEs), Adverse Events (AEs) Leading to Discontinuation, and Immune-related AEs - Treated Participants | Grade 3-4 AE | 2 participants |
| Ipilimumab Monotherapy 3 mg/kg | Number of Participants With Serious AEs (SAEs), Adverse Events (AEs) Leading to Discontinuation, and Immune-related AEs - Treated Participants | Grade 3-4 Related AE | 2 participants |
| Ipilimumab Monotherapy 3 mg/kg | Number of Participants With Serious AEs (SAEs), Adverse Events (AEs) Leading to Discontinuation, and Immune-related AEs - Treated Participants | Related-AEs leading to discontinuation | 2 participants |
| Ipilimumab Monotherapy 3 mg/kg | Number of Participants With Serious AEs (SAEs), Adverse Events (AEs) Leading to Discontinuation, and Immune-related AEs - Treated Participants | SAE | 3 participants |
| Ipilimumab Monotherapy 3 mg/kg | Number of Participants With Serious AEs (SAEs), Adverse Events (AEs) Leading to Discontinuation, and Immune-related AEs - Treated Participants | Related AE (Any Grade) | 8 participants |
| Ipilimumab Monotherapy 5 mg/kg | Number of Participants With Serious AEs (SAEs), Adverse Events (AEs) Leading to Discontinuation, and Immune-related AEs - Treated Participants | Grade 3-4 irAE | 3 participants |
| Ipilimumab Monotherapy 5 mg/kg | Number of Participants With Serious AEs (SAEs), Adverse Events (AEs) Leading to Discontinuation, and Immune-related AEs - Treated Participants | Grade 3-4 AE | 5 participants |
| Ipilimumab Monotherapy 5 mg/kg | Number of Participants With Serious AEs (SAEs), Adverse Events (AEs) Leading to Discontinuation, and Immune-related AEs - Treated Participants | Drug-Related SAE | 1 participants |
| Ipilimumab Monotherapy 5 mg/kg | Number of Participants With Serious AEs (SAEs), Adverse Events (AEs) Leading to Discontinuation, and Immune-related AEs - Treated Participants | irAE (Any Grade) | 5 participants |
| Ipilimumab Monotherapy 5 mg/kg | Number of Participants With Serious AEs (SAEs), Adverse Events (AEs) Leading to Discontinuation, and Immune-related AEs - Treated Participants | AEs leading to discontinuation | 2 participants |
| Ipilimumab Monotherapy 5 mg/kg | Number of Participants With Serious AEs (SAEs), Adverse Events (AEs) Leading to Discontinuation, and Immune-related AEs - Treated Participants | SAE | 2 participants |
| Ipilimumab Monotherapy 5 mg/kg | Number of Participants With Serious AEs (SAEs), Adverse Events (AEs) Leading to Discontinuation, and Immune-related AEs - Treated Participants | Grade 3-4 Related AE | 3 participants |
| Ipilimumab Monotherapy 5 mg/kg | Number of Participants With Serious AEs (SAEs), Adverse Events (AEs) Leading to Discontinuation, and Immune-related AEs - Treated Participants | Related-AEs leading to discontinuation | 2 participants |
| Ipilimumab Monotherapy 5 mg/kg | Number of Participants With Serious AEs (SAEs), Adverse Events (AEs) Leading to Discontinuation, and Immune-related AEs - Treated Participants | Related AE (Any Grade) | 5 participants |
| Ipilimumab Monotherapy 10 mg/kg | Number of Participants With Serious AEs (SAEs), Adverse Events (AEs) Leading to Discontinuation, and Immune-related AEs - Treated Participants | Related AE (Any Grade) | 16 participants |
| Ipilimumab Monotherapy 10 mg/kg | Number of Participants With Serious AEs (SAEs), Adverse Events (AEs) Leading to Discontinuation, and Immune-related AEs - Treated Participants | Drug-Related SAE | 7 participants |
| Ipilimumab Monotherapy 10 mg/kg | Number of Participants With Serious AEs (SAEs), Adverse Events (AEs) Leading to Discontinuation, and Immune-related AEs - Treated Participants | AEs leading to discontinuation | 7 participants |
| Ipilimumab Monotherapy 10 mg/kg | Number of Participants With Serious AEs (SAEs), Adverse Events (AEs) Leading to Discontinuation, and Immune-related AEs - Treated Participants | Related-AEs leading to discontinuation | 6 participants |
| Ipilimumab Monotherapy 10 mg/kg | Number of Participants With Serious AEs (SAEs), Adverse Events (AEs) Leading to Discontinuation, and Immune-related AEs - Treated Participants | Grade 3-4 AE | 12 participants |
| Ipilimumab Monotherapy 10 mg/kg | Number of Participants With Serious AEs (SAEs), Adverse Events (AEs) Leading to Discontinuation, and Immune-related AEs - Treated Participants | SAE | 9 participants |
| Ipilimumab Monotherapy 10 mg/kg | Number of Participants With Serious AEs (SAEs), Adverse Events (AEs) Leading to Discontinuation, and Immune-related AEs - Treated Participants | Grade 3-4 Related AE | 10 participants |
| Ipilimumab Monotherapy 10 mg/kg | Number of Participants With Serious AEs (SAEs), Adverse Events (AEs) Leading to Discontinuation, and Immune-related AEs - Treated Participants | irAE (Any Grade) | 16 participants |
| Ipilimumab Monotherapy 10 mg/kg | Number of Participants With Serious AEs (SAEs), Adverse Events (AEs) Leading to Discontinuation, and Immune-related AEs - Treated Participants | Grade 3-4 irAE | 10 participants |
| Ipilimumab 3 mg/kg + XRT Combination Therapy | Number of Participants With Serious AEs (SAEs), Adverse Events (AEs) Leading to Discontinuation, and Immune-related AEs - Treated Participants | Related-AEs leading to discontinuation | 3 participants |
| Ipilimumab 3 mg/kg + XRT Combination Therapy | Number of Participants With Serious AEs (SAEs), Adverse Events (AEs) Leading to Discontinuation, and Immune-related AEs - Treated Participants | Related AE (Any Grade) | 6 participants |
| Ipilimumab 3 mg/kg + XRT Combination Therapy | Number of Participants With Serious AEs (SAEs), Adverse Events (AEs) Leading to Discontinuation, and Immune-related AEs - Treated Participants | AEs leading to discontinuation | 3 participants |
| Ipilimumab 3 mg/kg + XRT Combination Therapy | Number of Participants With Serious AEs (SAEs), Adverse Events (AEs) Leading to Discontinuation, and Immune-related AEs - Treated Participants | Grade 3-4 Related AE | 3 participants |
| Ipilimumab 3 mg/kg + XRT Combination Therapy | Number of Participants With Serious AEs (SAEs), Adverse Events (AEs) Leading to Discontinuation, and Immune-related AEs - Treated Participants | Drug-Related SAE | 2 participants |
| Ipilimumab 3 mg/kg + XRT Combination Therapy | Number of Participants With Serious AEs (SAEs), Adverse Events (AEs) Leading to Discontinuation, and Immune-related AEs - Treated Participants | Grade 3-4 irAE | 3 participants |
| Ipilimumab 3 mg/kg + XRT Combination Therapy | Number of Participants With Serious AEs (SAEs), Adverse Events (AEs) Leading to Discontinuation, and Immune-related AEs - Treated Participants | irAE (Any Grade) | 4 participants |
| Ipilimumab 3 mg/kg + XRT Combination Therapy | Number of Participants With Serious AEs (SAEs), Adverse Events (AEs) Leading to Discontinuation, and Immune-related AEs - Treated Participants | Grade 3-4 AE | 3 participants |
| Ipilimumab 3 mg/kg + XRT Combination Therapy | Number of Participants With Serious AEs (SAEs), Adverse Events (AEs) Leading to Discontinuation, and Immune-related AEs - Treated Participants | SAE | 2 participants |
| Ipilimumab 10 mg/kg + XRT Combination | Number of Participants With Serious AEs (SAEs), Adverse Events (AEs) Leading to Discontinuation, and Immune-related AEs - Treated Participants | SAE | 19 participants |
| Ipilimumab 10 mg/kg + XRT Combination | Number of Participants With Serious AEs (SAEs), Adverse Events (AEs) Leading to Discontinuation, and Immune-related AEs - Treated Participants | Related-AEs leading to discontinuation | 8 participants |
| Ipilimumab 10 mg/kg + XRT Combination | Number of Participants With Serious AEs (SAEs), Adverse Events (AEs) Leading to Discontinuation, and Immune-related AEs - Treated Participants | Related AE (Any Grade) | 29 participants |
| Ipilimumab 10 mg/kg + XRT Combination | Number of Participants With Serious AEs (SAEs), Adverse Events (AEs) Leading to Discontinuation, and Immune-related AEs - Treated Participants | AEs leading to discontinuation | 13 participants |
| Ipilimumab 10 mg/kg + XRT Combination | Number of Participants With Serious AEs (SAEs), Adverse Events (AEs) Leading to Discontinuation, and Immune-related AEs - Treated Participants | Grade 3-4 AE | 20 participants |
| Ipilimumab 10 mg/kg + XRT Combination | Number of Participants With Serious AEs (SAEs), Adverse Events (AEs) Leading to Discontinuation, and Immune-related AEs - Treated Participants | Grade 3-4 irAE | 6 participants |
| Ipilimumab 10 mg/kg + XRT Combination | Number of Participants With Serious AEs (SAEs), Adverse Events (AEs) Leading to Discontinuation, and Immune-related AEs - Treated Participants | irAE (Any Grade) | 24 participants |
| Ipilimumab 10 mg/kg + XRT Combination | Number of Participants With Serious AEs (SAEs), Adverse Events (AEs) Leading to Discontinuation, and Immune-related AEs - Treated Participants | Grade 3-4 Related AE | 13 participants |
| Ipilimumab 10 mg/kg + XRT Combination | Number of Participants With Serious AEs (SAEs), Adverse Events (AEs) Leading to Discontinuation, and Immune-related AEs - Treated Participants | Drug-Related SAE | 7 participants |
Secondary
Number of Participants Positive for Human Anti-Human Antibodies (HAHA) - Treated Participants
HAHA was measured by electrochemiluminescent (ECL) immunoassay for the detection of antibodies in human heparin plasma. Testing was performed on Days 1 (prior to ipilimumab infusion), 64, 85, and at completion of treatment.
Time frame: Day 1 up to 2 years
Population: All participants in the study who received either ipilimumab or radiation and had a measurement were analyzed.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Ipilimumab Monotherapy 3 mg/kg | Number of Participants Positive for Human Anti-Human Antibodies (HAHA) - Treated Participants | 0 participants |
| Ipilimumab Monotherapy 5 mg/kg | Number of Participants Positive for Human Anti-Human Antibodies (HAHA) - Treated Participants | 0 participants |
| Ipilimumab Monotherapy 10 mg/kg | Number of Participants Positive for Human Anti-Human Antibodies (HAHA) - Treated Participants | 0 participants |
| Ipilimumab 3 mg/kg + XRT Combination Therapy | Number of Participants Positive for Human Anti-Human Antibodies (HAHA) - Treated Participants | 0 participants |
| Ipilimumab 10 mg/kg + XRT Combination | Number of Participants Positive for Human Anti-Human Antibodies (HAHA) - Treated Participants | 0 participants |
Secondary
Number of Participants Who Died by Date of Primary Analysis and by Date of Completion of Follow Up - All Treated Participants
Primary analysis was conducted on data from Day 1 up to 2 years post treatment, data available as of September 2009. Final Follow-Up analysis was conducted on data up to 5 years post treatment, data available as of September 2013 (minimum time of eligibility 54 months to a maximum of 85 months). Primary causes of deaths are listed under each timepoint.
Time frame: Day 1 to 5 years post treatment
Population: Treated participants population included all participants in the study who received either ipilimumab or radiation.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Ipilimumab Monotherapy 3 mg/kg | Number of Participants Who Died by Date of Primary Analysis and by Date of Completion of Follow Up - All Treated Participants | Prostate Cancer | 1 participants |
| Ipilimumab Monotherapy 3 mg/kg | Number of Participants Who Died by Date of Primary Analysis and by Date of Completion of Follow Up - All Treated Participants | Total Deaths at Primary Analysis | 5 participants |
| Ipilimumab Monotherapy 3 mg/kg | Number of Participants Who Died by Date of Primary Analysis and by Date of Completion of Follow Up - All Treated Participants | Maliginant Disease | 0 participants |
| Ipilimumab Monotherapy 3 mg/kg | Number of Participants Who Died by Date of Primary Analysis and by Date of Completion of Follow Up - All Treated Participants | No cause specified | 1 participants |
| Ipilimumab Monotherapy 3 mg/kg | Number of Participants Who Died by Date of Primary Analysis and by Date of Completion of Follow Up - All Treated Participants | Other | 0 participants |
| Ipilimumab Monotherapy 3 mg/kg | Number of Participants Who Died by Date of Primary Analysis and by Date of Completion of Follow Up - All Treated Participants | Unknown | 5 participants |
| Ipilimumab Monotherapy 3 mg/kg | Number of Participants Who Died by Date of Primary Analysis and by Date of Completion of Follow Up - All Treated Participants | Toxicity | 0 participants |
| Ipilimumab Monotherapy 3 mg/kg | Number of Participants Who Died by Date of Primary Analysis and by Date of Completion of Follow Up - All Treated Participants | No cause specified | 1 participants |
| Ipilimumab Monotherapy 3 mg/kg | Number of Participants Who Died by Date of Primary Analysis and by Date of Completion of Follow Up - All Treated Participants | Total Deaths at Completion of Follow Up | 7 participants |
| Ipilimumab Monotherapy 3 mg/kg | Number of Participants Who Died by Date of Primary Analysis and by Date of Completion of Follow Up - All Treated Participants | Prostate Cancer | 1 participants |
| Ipilimumab Monotherapy 3 mg/kg | Number of Participants Who Died by Date of Primary Analysis and by Date of Completion of Follow Up - All Treated Participants | Malignant Disease | 0 participants |
| Ipilimumab Monotherapy 3 mg/kg | Number of Participants Who Died by Date of Primary Analysis and by Date of Completion of Follow Up - All Treated Participants | Unknown | 3 participants |
| Ipilimumab Monotherapy 3 mg/kg | Number of Participants Who Died by Date of Primary Analysis and by Date of Completion of Follow Up - All Treated Participants | Other | 0 participants |
| Ipilimumab Monotherapy 3 mg/kg | Number of Participants Who Died by Date of Primary Analysis and by Date of Completion of Follow Up - All Treated Participants | Toxicity | 0 participants |
| Ipilimumab Monotherapy 5 mg/kg | Number of Participants Who Died by Date of Primary Analysis and by Date of Completion of Follow Up - All Treated Participants | Other | 0 participants |
| Ipilimumab Monotherapy 5 mg/kg | Number of Participants Who Died by Date of Primary Analysis and by Date of Completion of Follow Up - All Treated Participants | No cause specified | 0 participants |
| Ipilimumab Monotherapy 5 mg/kg | Number of Participants Who Died by Date of Primary Analysis and by Date of Completion of Follow Up - All Treated Participants | Maliginant Disease | 0 participants |
| Ipilimumab Monotherapy 5 mg/kg | Number of Participants Who Died by Date of Primary Analysis and by Date of Completion of Follow Up - All Treated Participants | Unknown | 0 participants |
| Ipilimumab Monotherapy 5 mg/kg | Number of Participants Who Died by Date of Primary Analysis and by Date of Completion of Follow Up - All Treated Participants | Total Deaths at Completion of Follow Up | 6 participants |
| Ipilimumab Monotherapy 5 mg/kg | Number of Participants Who Died by Date of Primary Analysis and by Date of Completion of Follow Up - All Treated Participants | Toxicity | 1 participants |
| Ipilimumab Monotherapy 5 mg/kg | Number of Participants Who Died by Date of Primary Analysis and by Date of Completion of Follow Up - All Treated Participants | No cause specified | 0 participants |
| Ipilimumab Monotherapy 5 mg/kg | Number of Participants Who Died by Date of Primary Analysis and by Date of Completion of Follow Up - All Treated Participants | Prostate Cancer | 3 participants |
| Ipilimumab Monotherapy 5 mg/kg | Number of Participants Who Died by Date of Primary Analysis and by Date of Completion of Follow Up - All Treated Participants | Total Deaths at Primary Analysis | 4 participants |
| Ipilimumab Monotherapy 5 mg/kg | Number of Participants Who Died by Date of Primary Analysis and by Date of Completion of Follow Up - All Treated Participants | Unknown | 0 participants |
| Ipilimumab Monotherapy 5 mg/kg | Number of Participants Who Died by Date of Primary Analysis and by Date of Completion of Follow Up - All Treated Participants | Toxicity | 1 participants |
| Ipilimumab Monotherapy 5 mg/kg | Number of Participants Who Died by Date of Primary Analysis and by Date of Completion of Follow Up - All Treated Participants | Prostate Cancer | 4 participants |
| Ipilimumab Monotherapy 5 mg/kg | Number of Participants Who Died by Date of Primary Analysis and by Date of Completion of Follow Up - All Treated Participants | Other | 1 participants |
| Ipilimumab Monotherapy 5 mg/kg | Number of Participants Who Died by Date of Primary Analysis and by Date of Completion of Follow Up - All Treated Participants | Malignant Disease | 0 participants |
| Ipilimumab Monotherapy 10 mg/kg | Number of Participants Who Died by Date of Primary Analysis and by Date of Completion of Follow Up - All Treated Participants | Toxicity | 0 participants |
| Ipilimumab Monotherapy 10 mg/kg | Number of Participants Who Died by Date of Primary Analysis and by Date of Completion of Follow Up - All Treated Participants | Total Deaths at Completion of Follow Up | 11 participants |
| Ipilimumab Monotherapy 10 mg/kg | Number of Participants Who Died by Date of Primary Analysis and by Date of Completion of Follow Up - All Treated Participants | Maliginant Disease | 0 participants |
| Ipilimumab Monotherapy 10 mg/kg | Number of Participants Who Died by Date of Primary Analysis and by Date of Completion of Follow Up - All Treated Participants | Unknown | 4 participants |
| Ipilimumab Monotherapy 10 mg/kg | Number of Participants Who Died by Date of Primary Analysis and by Date of Completion of Follow Up - All Treated Participants | Prostate Cancer | 4 participants |
| Ipilimumab Monotherapy 10 mg/kg | Number of Participants Who Died by Date of Primary Analysis and by Date of Completion of Follow Up - All Treated Participants | Toxicity | 0 participants |
| Ipilimumab Monotherapy 10 mg/kg | Number of Participants Who Died by Date of Primary Analysis and by Date of Completion of Follow Up - All Treated Participants | Total Deaths at Primary Analysis | 7 participants |
| Ipilimumab Monotherapy 10 mg/kg | Number of Participants Who Died by Date of Primary Analysis and by Date of Completion of Follow Up - All Treated Participants | Other | 1 participants |
| Ipilimumab Monotherapy 10 mg/kg | Number of Participants Who Died by Date of Primary Analysis and by Date of Completion of Follow Up - All Treated Participants | Other | 0 participants |
| Ipilimumab Monotherapy 10 mg/kg | Number of Participants Who Died by Date of Primary Analysis and by Date of Completion of Follow Up - All Treated Participants | Malignant Disease | 0 participants |
| Ipilimumab Monotherapy 10 mg/kg | Number of Participants Who Died by Date of Primary Analysis and by Date of Completion of Follow Up - All Treated Participants | Unknown | 3 participants |
| Ipilimumab Monotherapy 10 mg/kg | Number of Participants Who Died by Date of Primary Analysis and by Date of Completion of Follow Up - All Treated Participants | No cause specified | 0 participants |
| Ipilimumab Monotherapy 10 mg/kg | Number of Participants Who Died by Date of Primary Analysis and by Date of Completion of Follow Up - All Treated Participants | Prostate Cancer | 6 participants |
| Ipilimumab Monotherapy 10 mg/kg | Number of Participants Who Died by Date of Primary Analysis and by Date of Completion of Follow Up - All Treated Participants | No cause specified | 0 participants |
| Ipilimumab 3 mg/kg + XRT Combination Therapy | Number of Participants Who Died by Date of Primary Analysis and by Date of Completion of Follow Up - All Treated Participants | Toxicity | 0 participants |
| Ipilimumab 3 mg/kg + XRT Combination Therapy | Number of Participants Who Died by Date of Primary Analysis and by Date of Completion of Follow Up - All Treated Participants | Total Deaths at Primary Analysis | 3 participants |
| Ipilimumab 3 mg/kg + XRT Combination Therapy | Number of Participants Who Died by Date of Primary Analysis and by Date of Completion of Follow Up - All Treated Participants | Maliginant Disease | 0 participants |
| Ipilimumab 3 mg/kg + XRT Combination Therapy | Number of Participants Who Died by Date of Primary Analysis and by Date of Completion of Follow Up - All Treated Participants | Prostate Cancer | 3 participants |
| Ipilimumab 3 mg/kg + XRT Combination Therapy | Number of Participants Who Died by Date of Primary Analysis and by Date of Completion of Follow Up - All Treated Participants | Toxicity | 0 participants |
| Ipilimumab 3 mg/kg + XRT Combination Therapy | Number of Participants Who Died by Date of Primary Analysis and by Date of Completion of Follow Up - All Treated Participants | Other | 0 participants |
| Ipilimumab 3 mg/kg + XRT Combination Therapy | Number of Participants Who Died by Date of Primary Analysis and by Date of Completion of Follow Up - All Treated Participants | Unknown | 0 participants |
| Ipilimumab 3 mg/kg + XRT Combination Therapy | Number of Participants Who Died by Date of Primary Analysis and by Date of Completion of Follow Up - All Treated Participants | No cause specified | 0 participants |
| Ipilimumab 3 mg/kg + XRT Combination Therapy | Number of Participants Who Died by Date of Primary Analysis and by Date of Completion of Follow Up - All Treated Participants | Total Deaths at Completion of Follow Up | 7 participants |
| Ipilimumab 3 mg/kg + XRT Combination Therapy | Number of Participants Who Died by Date of Primary Analysis and by Date of Completion of Follow Up - All Treated Participants | Malignant Disease | 0 participants |
| Ipilimumab 3 mg/kg + XRT Combination Therapy | Number of Participants Who Died by Date of Primary Analysis and by Date of Completion of Follow Up - All Treated Participants | Prostate Cancer | 4 participants |
| Ipilimumab 3 mg/kg + XRT Combination Therapy | Number of Participants Who Died by Date of Primary Analysis and by Date of Completion of Follow Up - All Treated Participants | Other | 0 participants |
| Ipilimumab 3 mg/kg + XRT Combination Therapy | Number of Participants Who Died by Date of Primary Analysis and by Date of Completion of Follow Up - All Treated Participants | Unknown | 3 participants |
| Ipilimumab 3 mg/kg + XRT Combination Therapy | Number of Participants Who Died by Date of Primary Analysis and by Date of Completion of Follow Up - All Treated Participants | No cause specified | 0 participants |
| Ipilimumab 10 mg/kg + XRT Combination | Number of Participants Who Died by Date of Primary Analysis and by Date of Completion of Follow Up - All Treated Participants | Total Deaths at Completion of Follow Up | 29 participants |
| Ipilimumab 10 mg/kg + XRT Combination | Number of Participants Who Died by Date of Primary Analysis and by Date of Completion of Follow Up - All Treated Participants | Total Deaths at Primary Analysis | 18 participants |
| Ipilimumab 10 mg/kg + XRT Combination | Number of Participants Who Died by Date of Primary Analysis and by Date of Completion of Follow Up - All Treated Participants | Prostate Cancer | 13 participants |
| Ipilimumab 10 mg/kg + XRT Combination | Number of Participants Who Died by Date of Primary Analysis and by Date of Completion of Follow Up - All Treated Participants | No cause specified | 0 participants |
| Ipilimumab 10 mg/kg + XRT Combination | Number of Participants Who Died by Date of Primary Analysis and by Date of Completion of Follow Up - All Treated Participants | Unknown | 3 participants |
| Ipilimumab 10 mg/kg + XRT Combination | Number of Participants Who Died by Date of Primary Analysis and by Date of Completion of Follow Up - All Treated Participants | Toxicity | 0 participants |
| Ipilimumab 10 mg/kg + XRT Combination | Number of Participants Who Died by Date of Primary Analysis and by Date of Completion of Follow Up - All Treated Participants | Other | 2 participants |
| Ipilimumab 10 mg/kg + XRT Combination | Number of Participants Who Died by Date of Primary Analysis and by Date of Completion of Follow Up - All Treated Participants | Toxicity | 0 participants |
| Ipilimumab 10 mg/kg + XRT Combination | Number of Participants Who Died by Date of Primary Analysis and by Date of Completion of Follow Up - All Treated Participants | Other | 5 participants |
| Ipilimumab 10 mg/kg + XRT Combination | Number of Participants Who Died by Date of Primary Analysis and by Date of Completion of Follow Up - All Treated Participants | Prostate Cancer | 10 participants |
| Ipilimumab 10 mg/kg + XRT Combination | Number of Participants Who Died by Date of Primary Analysis and by Date of Completion of Follow Up - All Treated Participants | No cause specified | 0 participants |
| Ipilimumab 10 mg/kg + XRT Combination | Number of Participants Who Died by Date of Primary Analysis and by Date of Completion of Follow Up - All Treated Participants | Unknown | 8 participants |
| Ipilimumab 10 mg/kg + XRT Combination | Number of Participants Who Died by Date of Primary Analysis and by Date of Completion of Follow Up - All Treated Participants | Maliginant Disease | 3 participants |
| Ipilimumab 10 mg/kg + XRT Combination | Number of Participants Who Died by Date of Primary Analysis and by Date of Completion of Follow Up - All Treated Participants | Malignant Disease | 3 participants |
| Ipilimumab 10 mg/kg + XRT Combination (Chemotherapy Naive) | Number of Participants Who Died by Date of Primary Analysis and by Date of Completion of Follow Up - All Treated Participants | Total Deaths at Completion of Follow Up | 60 participants |
| Ipilimumab 10 mg/kg + XRT Combination (Chemotherapy Naive) | Number of Participants Who Died by Date of Primary Analysis and by Date of Completion of Follow Up - All Treated Participants | Other | 7 participants |
| Ipilimumab 10 mg/kg + XRT Combination (Chemotherapy Naive) | Number of Participants Who Died by Date of Primary Analysis and by Date of Completion of Follow Up - All Treated Participants | Prostate Cancer | 21 participants |
| Ipilimumab 10 mg/kg + XRT Combination (Chemotherapy Naive) | Number of Participants Who Died by Date of Primary Analysis and by Date of Completion of Follow Up - All Treated Participants | Prostate Cancer | 28 participants |
| Ipilimumab 10 mg/kg + XRT Combination (Chemotherapy Naive) | Number of Participants Who Died by Date of Primary Analysis and by Date of Completion of Follow Up - All Treated Participants | Total Deaths at Primary Analysis | 37 participants |
| Ipilimumab 10 mg/kg + XRT Combination (Chemotherapy Naive) | Number of Participants Who Died by Date of Primary Analysis and by Date of Completion of Follow Up - All Treated Participants | Unknown | 9 participants |
| Ipilimumab 10 mg/kg + XRT Combination (Chemotherapy Naive) | Number of Participants Who Died by Date of Primary Analysis and by Date of Completion of Follow Up - All Treated Participants | Maliginant Disease | 3 participants |
| Ipilimumab 10 mg/kg + XRT Combination (Chemotherapy Naive) | Number of Participants Who Died by Date of Primary Analysis and by Date of Completion of Follow Up - All Treated Participants | Other | 2 participants |
| Ipilimumab 10 mg/kg + XRT Combination (Chemotherapy Naive) | Number of Participants Who Died by Date of Primary Analysis and by Date of Completion of Follow Up - All Treated Participants | No cause specified | 1 participants |
| Ipilimumab 10 mg/kg + XRT Combination (Chemotherapy Naive) | Number of Participants Who Died by Date of Primary Analysis and by Date of Completion of Follow Up - All Treated Participants | Toxicity | 1 participants |
| Ipilimumab 10 mg/kg + XRT Combination (Chemotherapy Naive) | Number of Participants Who Died by Date of Primary Analysis and by Date of Completion of Follow Up - All Treated Participants | Malignant Disease | 3 participants |
| Ipilimumab 10 mg/kg + XRT Combination (Chemotherapy Naive) | Number of Participants Who Died by Date of Primary Analysis and by Date of Completion of Follow Up - All Treated Participants | Toxicity | 1 participants |
| Ipilimumab 10 mg/kg + XRT Combination (Chemotherapy Naive) | Number of Participants Who Died by Date of Primary Analysis and by Date of Completion of Follow Up - All Treated Participants | Unknown | 20 participants |
| Ipilimumab 10 mg/kg + XRT Combination (Chemotherapy Naive) | Number of Participants Who Died by Date of Primary Analysis and by Date of Completion of Follow Up - All Treated Participants | No cause specified | 1 participants |
Secondary
Number of Participants With Best Overall PSA Response by Category - PSA Evaluable Participants
Best Overall PSA response per investigator, using NCI PSA Working Group: PSA with CR or PR at any time after treatment initiation and was confirmed at least 4 weeks after the first measurement. PSA reference=PSA measured immediately prior to treatment. CR=PSA concentration \< 2 nanograms per milliliter (ng/mL), confirmed at least 4 weeks after 1st value; PR=PSA concentration ≤ 50% of PSA reference, confirmed at least 4 weeks after 1st value; Unconfirmed=not confirmed by repeat measurements; SD=No change from PSA reference value; PD = If PSA nadir was ≥ 100% of the reference value: PSA ≥ 125% of PSA reference and with a difference of absolute value of ≥ 5 ng/mL; If PSA nadir was \< 100% and ≥ 50% of the reference value: PSA ≥ 125% of PSA nadir and with a difference of absolute value of ≥ 5 ng/mL: If PSA nadir was \< 50% of the reference value: PSA ≥ 150% of PSA nadir and with a difference of absolute value of ≥ 5 ng/mL.
Time frame: Day 1 to last day of study treatment (+70 days) up to 2 years
Population: PSA-evaluable participants, including all participants in cohorts with monotherapy and with radiotherapy who received any ipilimumab and had a baseline PSA, were analyzed.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Ipilimumab Monotherapy 3 mg/kg | Number of Participants With Best Overall PSA Response by Category - PSA Evaluable Participants | Partial Response (PR) | 2 participants |
| Ipilimumab Monotherapy 3 mg/kg | Number of Participants With Best Overall PSA Response by Category - PSA Evaluable Participants | Progressive Disease (PD) | 3 participants |
| Ipilimumab Monotherapy 3 mg/kg | Number of Participants With Best Overall PSA Response by Category - PSA Evaluable Participants | Complete Response (CR) | 0 participants |
| Ipilimumab Monotherapy 3 mg/kg | Number of Participants With Best Overall PSA Response by Category - PSA Evaluable Participants | Unconfirmed Partial Response | 0 participants |
| Ipilimumab Monotherapy 3 mg/kg | Number of Participants With Best Overall PSA Response by Category - PSA Evaluable Participants | Stable Disease (SD) | 3 participants |
| Ipilimumab Monotherapy 3 mg/kg | Number of Participants With Best Overall PSA Response by Category - PSA Evaluable Participants | Unknown | 0 participants |
| Ipilimumab Monotherapy 5 mg/kg | Number of Participants With Best Overall PSA Response by Category - PSA Evaluable Participants | Unconfirmed Partial Response | 0 participants |
| Ipilimumab Monotherapy 5 mg/kg | Number of Participants With Best Overall PSA Response by Category - PSA Evaluable Participants | Unknown | 0 participants |
| Ipilimumab Monotherapy 5 mg/kg | Number of Participants With Best Overall PSA Response by Category - PSA Evaluable Participants | Stable Disease (SD) | 4 participants |
| Ipilimumab Monotherapy 5 mg/kg | Number of Participants With Best Overall PSA Response by Category - PSA Evaluable Participants | Partial Response (PR) | 1 participants |
| Ipilimumab Monotherapy 5 mg/kg | Number of Participants With Best Overall PSA Response by Category - PSA Evaluable Participants | Complete Response (CR) | 0 participants |
| Ipilimumab Monotherapy 5 mg/kg | Number of Participants With Best Overall PSA Response by Category - PSA Evaluable Participants | Progressive Disease (PD) | 1 participants |
| Ipilimumab Monotherapy 10 mg/kg | Number of Participants With Best Overall PSA Response by Category - PSA Evaluable Participants | Complete Response (CR) | 1 participants |
| Ipilimumab Monotherapy 10 mg/kg | Number of Participants With Best Overall PSA Response by Category - PSA Evaluable Participants | Unconfirmed Partial Response | 2 participants |
| Ipilimumab Monotherapy 10 mg/kg | Number of Participants With Best Overall PSA Response by Category - PSA Evaluable Participants | Unknown | 1 participants |
| Ipilimumab Monotherapy 10 mg/kg | Number of Participants With Best Overall PSA Response by Category - PSA Evaluable Participants | Stable Disease (SD) | 6 participants |
| Ipilimumab Monotherapy 10 mg/kg | Number of Participants With Best Overall PSA Response by Category - PSA Evaluable Participants | Progressive Disease (PD) | 3 participants |
| Ipilimumab Monotherapy 10 mg/kg | Number of Participants With Best Overall PSA Response by Category - PSA Evaluable Participants | Partial Response (PR) | 3 participants |
| Ipilimumab 3 mg/kg + XRT Combination Therapy | Number of Participants With Best Overall PSA Response by Category - PSA Evaluable Participants | Partial Response (PR) | 2 participants |
| Ipilimumab 3 mg/kg + XRT Combination Therapy | Number of Participants With Best Overall PSA Response by Category - PSA Evaluable Participants | Unconfirmed Partial Response | 0 participants |
| Ipilimumab 3 mg/kg + XRT Combination Therapy | Number of Participants With Best Overall PSA Response by Category - PSA Evaluable Participants | Unknown | 0 participants |
| Ipilimumab 3 mg/kg + XRT Combination Therapy | Number of Participants With Best Overall PSA Response by Category - PSA Evaluable Participants | Stable Disease (SD) | 2 participants |
| Ipilimumab 3 mg/kg + XRT Combination Therapy | Number of Participants With Best Overall PSA Response by Category - PSA Evaluable Participants | Complete Response (CR) | 0 participants |
| Ipilimumab 3 mg/kg + XRT Combination Therapy | Number of Participants With Best Overall PSA Response by Category - PSA Evaluable Participants | Progressive Disease (PD) | 2 participants |
| Ipilimumab 10 mg/kg + XRT Combination | Number of Participants With Best Overall PSA Response by Category - PSA Evaluable Participants | Unknown | 3 participants |
| Ipilimumab 10 mg/kg + XRT Combination | Number of Participants With Best Overall PSA Response by Category - PSA Evaluable Participants | Complete Response (CR) | 2 participants |
| Ipilimumab 10 mg/kg + XRT Combination | Number of Participants With Best Overall PSA Response by Category - PSA Evaluable Participants | Partial Response (PR) | 2 participants |
| Ipilimumab 10 mg/kg + XRT Combination | Number of Participants With Best Overall PSA Response by Category - PSA Evaluable Participants | Unconfirmed Partial Response | 2 participants |
| Ipilimumab 10 mg/kg + XRT Combination | Number of Participants With Best Overall PSA Response by Category - PSA Evaluable Participants | Stable Disease (SD) | 14 participants |
| Ipilimumab 10 mg/kg + XRT Combination | Number of Participants With Best Overall PSA Response by Category - PSA Evaluable Participants | Progressive Disease (PD) | 11 participants |
Secondary
Number of Participants With Best Overall Tumor Response by Category - Tumor Evaluable Participants
For those with measurable disease, tumor response based upon tumor lesions (per investigator) using Response Evaluation Criteria in Solid Tumors (RECIST). Best Overall=Participants with a best tumor response of CR or PR at anytime during the study. CR=Disappearance of all target lesions; PR=At least a 30% decrease in the sum of the longest diameter (LD) of target lesions taking as reference, baseline sum LD. For a status of CR or PR, changes in tumor measurements were confirmed by repeat studies no less than 4 weeks after the criteria for response were first met; Unconfirmed=not confirmed by repeat measurements; SD=Neither sufficient decrease to qualify for PR nor sufficient increase to qualify for progressive disease (PD), taking as reference the smallest sum LD since the treatment started; PD=At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.
Time frame: Day 1 to last day of study treatment (+70 days) up to 2 years
Population: Tumor-evaluable participants, including all participants in cohorts with monotherapy and with radiotherapy who received any ipilimumab and had measurable disease at baseline, were analyzed.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Ipilimumab Monotherapy 3 mg/kg | Number of Participants With Best Overall Tumor Response by Category - Tumor Evaluable Participants | Unknown | 0 participants |
| Ipilimumab Monotherapy 3 mg/kg | Number of Participants With Best Overall Tumor Response by Category - Tumor Evaluable Participants | Progressive Disease | 0 participants |
| Ipilimumab Monotherapy 3 mg/kg | Number of Participants With Best Overall Tumor Response by Category - Tumor Evaluable Participants | Partial Response | 0 participants |
| Ipilimumab Monotherapy 3 mg/kg | Number of Participants With Best Overall Tumor Response by Category - Tumor Evaluable Participants | Complete Response | 0 participants |
| Ipilimumab Monotherapy 3 mg/kg | Number of Participants With Best Overall Tumor Response by Category - Tumor Evaluable Participants | Unconfirmed Partial Response | 0 participants |
| Ipilimumab Monotherapy 3 mg/kg | Number of Participants With Best Overall Tumor Response by Category - Tumor Evaluable Participants | Stable Disease | 1 participants |
| Ipilimumab Monotherapy 5 mg/kg | Number of Participants With Best Overall Tumor Response by Category - Tumor Evaluable Participants | Partial Response | 0 participants |
| Ipilimumab Monotherapy 5 mg/kg | Number of Participants With Best Overall Tumor Response by Category - Tumor Evaluable Participants | Unknown | 0 participants |
| Ipilimumab Monotherapy 5 mg/kg | Number of Participants With Best Overall Tumor Response by Category - Tumor Evaluable Participants | Stable Disease | 1 participants |
| Ipilimumab Monotherapy 5 mg/kg | Number of Participants With Best Overall Tumor Response by Category - Tumor Evaluable Participants | Unconfirmed Partial Response | 0 participants |
| Ipilimumab Monotherapy 5 mg/kg | Number of Participants With Best Overall Tumor Response by Category - Tumor Evaluable Participants | Progressive Disease | 0 participants |
| Ipilimumab Monotherapy 5 mg/kg | Number of Participants With Best Overall Tumor Response by Category - Tumor Evaluable Participants | Complete Response | 0 participants |
| Ipilimumab Monotherapy 10 mg/kg | Number of Participants With Best Overall Tumor Response by Category - Tumor Evaluable Participants | Unconfirmed Partial Response | 1 participants |
| Ipilimumab Monotherapy 10 mg/kg | Number of Participants With Best Overall Tumor Response by Category - Tumor Evaluable Participants | Partial Response | 0 participants |
| Ipilimumab Monotherapy 10 mg/kg | Number of Participants With Best Overall Tumor Response by Category - Tumor Evaluable Participants | Complete Response | 1 participants |
| Ipilimumab Monotherapy 10 mg/kg | Number of Participants With Best Overall Tumor Response by Category - Tumor Evaluable Participants | Stable Disease | 1 participants |
| Ipilimumab Monotherapy 10 mg/kg | Number of Participants With Best Overall Tumor Response by Category - Tumor Evaluable Participants | Unknown | 2 participants |
| Ipilimumab Monotherapy 10 mg/kg | Number of Participants With Best Overall Tumor Response by Category - Tumor Evaluable Participants | Progressive Disease | 3 participants |
| Ipilimumab 3 mg/kg + XRT Combination Therapy | Number of Participants With Best Overall Tumor Response by Category - Tumor Evaluable Participants | Progressive Disease | 1 participants |
| Ipilimumab 3 mg/kg + XRT Combination Therapy | Number of Participants With Best Overall Tumor Response by Category - Tumor Evaluable Participants | Unknown | 0 participants |
| Ipilimumab 3 mg/kg + XRT Combination Therapy | Number of Participants With Best Overall Tumor Response by Category - Tumor Evaluable Participants | Partial Response | 0 participants |
| Ipilimumab 3 mg/kg + XRT Combination Therapy | Number of Participants With Best Overall Tumor Response by Category - Tumor Evaluable Participants | Unconfirmed Partial Response | 0 participants |
| Ipilimumab 3 mg/kg + XRT Combination Therapy | Number of Participants With Best Overall Tumor Response by Category - Tumor Evaluable Participants | Stable Disease | 1 participants |
| Ipilimumab 3 mg/kg + XRT Combination Therapy | Number of Participants With Best Overall Tumor Response by Category - Tumor Evaluable Participants | Complete Response | 0 participants |
| Ipilimumab 10 mg/kg + XRT Combination | Number of Participants With Best Overall Tumor Response by Category - Tumor Evaluable Participants | Unknown | 9 participants |
| Ipilimumab 10 mg/kg + XRT Combination | Number of Participants With Best Overall Tumor Response by Category - Tumor Evaluable Participants | Partial Response | 0 participants |
| Ipilimumab 10 mg/kg + XRT Combination | Number of Participants With Best Overall Tumor Response by Category - Tumor Evaluable Participants | Unconfirmed Partial Response | 1 participants |
| Ipilimumab 10 mg/kg + XRT Combination | Number of Participants With Best Overall Tumor Response by Category - Tumor Evaluable Participants | Stable Disease | 5 participants |
| Ipilimumab 10 mg/kg + XRT Combination | Number of Participants With Best Overall Tumor Response by Category - Tumor Evaluable Participants | Progressive Disease | 5 participants |
| Ipilimumab 10 mg/kg + XRT Combination | Number of Participants With Best Overall Tumor Response by Category - Tumor Evaluable Participants | Complete Response | 0 participants |
Secondary
Number of Participants With Clinically Significant Electrocardiogram (ECG) Abnormalities at Baseline and During Treatment Period - Treated Participants
12 Lead Electrocardiograms (ECGs) were performed at screening (Day -28 to Day -1), and on Day 85 during a treatment cycle, and at the end of treatment period. Clinically significant abnormalities could include atrial fibrillation, anterior fascicular block, marked sinus bradycardia, possible lateral infarct, and T-wave abnormality (other potential abnormalities were not excluded from consideration).
Time frame: Baseline up to 2 years
Population: All participants in the study who received either ipilimumab or radiation and had an ECG were analyzed.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Ipilimumab Monotherapy 3 mg/kg | Number of Participants With Clinically Significant Electrocardiogram (ECG) Abnormalities at Baseline and During Treatment Period - Treated Participants | ECG Abnormalities at Baseline (n=8, 6, 15, 7, 31) | 0 participants |
| Ipilimumab Monotherapy 3 mg/kg | Number of Participants With Clinically Significant Electrocardiogram (ECG) Abnormalities at Baseline and During Treatment Period - Treated Participants | ECG Abnormalities During Treatment (n=4,3,11,4,20) | 0 participants |
| Ipilimumab Monotherapy 5 mg/kg | Number of Participants With Clinically Significant Electrocardiogram (ECG) Abnormalities at Baseline and During Treatment Period - Treated Participants | ECG Abnormalities at Baseline (n=8, 6, 15, 7, 31) | 0 participants |
| Ipilimumab Monotherapy 5 mg/kg | Number of Participants With Clinically Significant Electrocardiogram (ECG) Abnormalities at Baseline and During Treatment Period - Treated Participants | ECG Abnormalities During Treatment (n=4,3,11,4,20) | 0 participants |
| Ipilimumab Monotherapy 10 mg/kg | Number of Participants With Clinically Significant Electrocardiogram (ECG) Abnormalities at Baseline and During Treatment Period - Treated Participants | ECG Abnormalities at Baseline (n=8, 6, 15, 7, 31) | 2 participants |
| Ipilimumab Monotherapy 10 mg/kg | Number of Participants With Clinically Significant Electrocardiogram (ECG) Abnormalities at Baseline and During Treatment Period - Treated Participants | ECG Abnormalities During Treatment (n=4,3,11,4,20) | 2 participants |
| Ipilimumab 3 mg/kg + XRT Combination Therapy | Number of Participants With Clinically Significant Electrocardiogram (ECG) Abnormalities at Baseline and During Treatment Period - Treated Participants | ECG Abnormalities During Treatment (n=4,3,11,4,20) | 0 participants |
| Ipilimumab 3 mg/kg + XRT Combination Therapy | Number of Participants With Clinically Significant Electrocardiogram (ECG) Abnormalities at Baseline and During Treatment Period - Treated Participants | ECG Abnormalities at Baseline (n=8, 6, 15, 7, 31) | 0 participants |
| Ipilimumab 10 mg/kg + XRT Combination | Number of Participants With Clinically Significant Electrocardiogram (ECG) Abnormalities at Baseline and During Treatment Period - Treated Participants | ECG Abnormalities at Baseline (n=8, 6, 15, 7, 31) | 0 participants |
| Ipilimumab 10 mg/kg + XRT Combination | Number of Participants With Clinically Significant Electrocardiogram (ECG) Abnormalities at Baseline and During Treatment Period - Treated Participants | ECG Abnormalities During Treatment (n=4,3,11,4,20) | 0 participants |
Secondary
Number of Participants With On-Study Hematology Laboratory Tests Worst Common Terminology Criteria (CTC) Grade - Treated Participants
NCI CTC version(v) 3.0 was used to determine Grade (Gr). Screening was Day -28 to Day -1. On-study laboratories were reported after the first dose date, every 21 days during a treatment cycle, and within 70 days of last dose of study therapy (ie, Days 1, 22, 43, 64, 85, etc). Hemoglobin grams per liter (g/L): Gr 1: 10.0 - less than (\<) lower limit of normal (LLN); Gr 2: 8.0 - \< 10.0; Gr 3: 6.5 - \< 8.0; Gr 4: \< 6.5. White blood cells(WBC) 10\^9 cells per liter (c/L): Gr1: 3.0 - \< LLN; Gr 2: 2.0 - \< 3.0; Gr 3: 1.0 - \< 2.0; Gr4: \< 1.0. Lymphocytes (absolute) 10\^9 c/L: Gr1: 0.8 - \< 1.5; Gr 2: 0.5 - \< 0.8; Gr 3): 0.2 - \< 0.5; Gr 4: \< 0.2. Neutrophils (absolute) 10\^9 c/L: Gr 1: 1.5 - \< 2.0; Gr 2: 1.0 - \< 1.5; Gr 3: 0.5 - \< 1.0; Gr 4: \< 0.5. Platelets 10\^9 c/L: Gr 1: 75.0 - \< lower limits of normal (LLN); Gr 2: 50.0 - \< 75.0; Gr 3: 25.0 - \< 50.0; Gr 4: \< 25.0.
Time frame: Day 1 to last day of study treatment (+70 days) up to 2 years
Population: All participants in the study who received either ipilimumab or radiation and had a laboratory measurement were analyzed.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Ipilimumab Monotherapy 3 mg/kg | Number of Participants With On-Study Hematology Laboratory Tests Worst Common Terminology Criteria (CTC) Grade - Treated Participants | Neutrophils Grade 1-4 (n=8, 5, 15, 6, 34) | 2 participants |
| Ipilimumab Monotherapy 3 mg/kg | Number of Participants With On-Study Hematology Laboratory Tests Worst Common Terminology Criteria (CTC) Grade - Treated Participants | Lymphocytes Grade 3-4 (n=8, 5, 15, 6, 34) | 0 participants |
| Ipilimumab Monotherapy 3 mg/kg | Number of Participants With On-Study Hematology Laboratory Tests Worst Common Terminology Criteria (CTC) Grade - Treated Participants | Neutrophils Grade 3-4 (n=8, 5, 15, 6, 34) | 0 participants |
| Ipilimumab Monotherapy 3 mg/kg | Number of Participants With On-Study Hematology Laboratory Tests Worst Common Terminology Criteria (CTC) Grade - Treated Participants | Lymphocytes Grade 1-4 (n=8, 5, 15, 6, 34) | 7 participants |
| Ipilimumab Monotherapy 3 mg/kg | Number of Participants With On-Study Hematology Laboratory Tests Worst Common Terminology Criteria (CTC) Grade - Treated Participants | Hemoglobin Grade 3-4 (n=8, 5, 15, 6, 34) | 0 participants |
| Ipilimumab Monotherapy 3 mg/kg | Number of Participants With On-Study Hematology Laboratory Tests Worst Common Terminology Criteria (CTC) Grade - Treated Participants | WBC Grade 3-4 (n=8, 5, 15, 6, 34) | 0 participants |
| Ipilimumab Monotherapy 3 mg/kg | Number of Participants With On-Study Hematology Laboratory Tests Worst Common Terminology Criteria (CTC) Grade - Treated Participants | WBC Grade 1-4 (n=8, 5, 15, 6, 34) | 0 participants |
| Ipilimumab Monotherapy 3 mg/kg | Number of Participants With On-Study Hematology Laboratory Tests Worst Common Terminology Criteria (CTC) Grade - Treated Participants | Hemoglobin Grade 1-4 (n=8, 5, 15, 6, 34) | 7 participants |
| Ipilimumab Monotherapy 3 mg/kg | Number of Participants With On-Study Hematology Laboratory Tests Worst Common Terminology Criteria (CTC) Grade - Treated Participants | Platelets Grade 3-4 (n=8, 5, 15, 6, 34) | 0 participants |
| Ipilimumab Monotherapy 3 mg/kg | Number of Participants With On-Study Hematology Laboratory Tests Worst Common Terminology Criteria (CTC) Grade - Treated Participants | Platelets Grade 1-4 (n=8, 5, 15, 6, 34) | 0 participants |
| Ipilimumab Monotherapy 5 mg/kg | Number of Participants With On-Study Hematology Laboratory Tests Worst Common Terminology Criteria (CTC) Grade - Treated Participants | WBC Grade 3-4 (n=8, 5, 15, 6, 34) | 0 participants |
| Ipilimumab Monotherapy 5 mg/kg | Number of Participants With On-Study Hematology Laboratory Tests Worst Common Terminology Criteria (CTC) Grade - Treated Participants | WBC Grade 1-4 (n=8, 5, 15, 6, 34) | 0 participants |
| Ipilimumab Monotherapy 5 mg/kg | Number of Participants With On-Study Hematology Laboratory Tests Worst Common Terminology Criteria (CTC) Grade - Treated Participants | Neutrophils Grade 1-4 (n=8, 5, 15, 6, 34) | 0 participants |
| Ipilimumab Monotherapy 5 mg/kg | Number of Participants With On-Study Hematology Laboratory Tests Worst Common Terminology Criteria (CTC) Grade - Treated Participants | Neutrophils Grade 3-4 (n=8, 5, 15, 6, 34) | 0 participants |
| Ipilimumab Monotherapy 5 mg/kg | Number of Participants With On-Study Hematology Laboratory Tests Worst Common Terminology Criteria (CTC) Grade - Treated Participants | Platelets Grade 1-4 (n=8, 5, 15, 6, 34) | 0 participants |
| Ipilimumab Monotherapy 5 mg/kg | Number of Participants With On-Study Hematology Laboratory Tests Worst Common Terminology Criteria (CTC) Grade - Treated Participants | Platelets Grade 3-4 (n=8, 5, 15, 6, 34) | 0 participants |
| Ipilimumab Monotherapy 5 mg/kg | Number of Participants With On-Study Hematology Laboratory Tests Worst Common Terminology Criteria (CTC) Grade - Treated Participants | Hemoglobin Grade 1-4 (n=8, 5, 15, 6, 34) | 4 participants |
| Ipilimumab Monotherapy 5 mg/kg | Number of Participants With On-Study Hematology Laboratory Tests Worst Common Terminology Criteria (CTC) Grade - Treated Participants | Hemoglobin Grade 3-4 (n=8, 5, 15, 6, 34) | 0 participants |
| Ipilimumab Monotherapy 5 mg/kg | Number of Participants With On-Study Hematology Laboratory Tests Worst Common Terminology Criteria (CTC) Grade - Treated Participants | Lymphocytes Grade 1-4 (n=8, 5, 15, 6, 34) | 3 participants |
| Ipilimumab Monotherapy 5 mg/kg | Number of Participants With On-Study Hematology Laboratory Tests Worst Common Terminology Criteria (CTC) Grade - Treated Participants | Lymphocytes Grade 3-4 (n=8, 5, 15, 6, 34) | 0 participants |
| Ipilimumab Monotherapy 10 mg/kg | Number of Participants With On-Study Hematology Laboratory Tests Worst Common Terminology Criteria (CTC) Grade - Treated Participants | Platelets Grade 3-4 (n=8, 5, 15, 6, 34) | 0 participants |
| Ipilimumab Monotherapy 10 mg/kg | Number of Participants With On-Study Hematology Laboratory Tests Worst Common Terminology Criteria (CTC) Grade - Treated Participants | Lymphocytes Grade 1-4 (n=8, 5, 15, 6, 34) | 12 participants |
| Ipilimumab Monotherapy 10 mg/kg | Number of Participants With On-Study Hematology Laboratory Tests Worst Common Terminology Criteria (CTC) Grade - Treated Participants | Neutrophils Grade 1-4 (n=8, 5, 15, 6, 34) | 0 participants |
| Ipilimumab Monotherapy 10 mg/kg | Number of Participants With On-Study Hematology Laboratory Tests Worst Common Terminology Criteria (CTC) Grade - Treated Participants | Neutrophils Grade 3-4 (n=8, 5, 15, 6, 34) | 0 participants |
| Ipilimumab Monotherapy 10 mg/kg | Number of Participants With On-Study Hematology Laboratory Tests Worst Common Terminology Criteria (CTC) Grade - Treated Participants | WBC Grade 3-4 (n=8, 5, 15, 6, 34) | 0 participants |
| Ipilimumab Monotherapy 10 mg/kg | Number of Participants With On-Study Hematology Laboratory Tests Worst Common Terminology Criteria (CTC) Grade - Treated Participants | Platelets Grade 1-4 (n=8, 5, 15, 6, 34) | 1 participants |
| Ipilimumab Monotherapy 10 mg/kg | Number of Participants With On-Study Hematology Laboratory Tests Worst Common Terminology Criteria (CTC) Grade - Treated Participants | Hemoglobin Grade 1-4 (n=8, 5, 15, 6, 34) | 12 participants |
| Ipilimumab Monotherapy 10 mg/kg | Number of Participants With On-Study Hematology Laboratory Tests Worst Common Terminology Criteria (CTC) Grade - Treated Participants | WBC Grade 1-4 (n=8, 5, 15, 6, 34) | 0 participants |
| Ipilimumab Monotherapy 10 mg/kg | Number of Participants With On-Study Hematology Laboratory Tests Worst Common Terminology Criteria (CTC) Grade - Treated Participants | Lymphocytes Grade 3-4 (n=8, 5, 15, 6, 34) | 2 participants |
| Ipilimumab Monotherapy 10 mg/kg | Number of Participants With On-Study Hematology Laboratory Tests Worst Common Terminology Criteria (CTC) Grade - Treated Participants | Hemoglobin Grade 3-4 (n=8, 5, 15, 6, 34) | 1 participants |
| Ipilimumab 3 mg/kg + XRT Combination Therapy | Number of Participants With On-Study Hematology Laboratory Tests Worst Common Terminology Criteria (CTC) Grade - Treated Participants | WBC Grade 3-4 (n=8, 5, 15, 6, 34) | 0 participants |
| Ipilimumab 3 mg/kg + XRT Combination Therapy | Number of Participants With On-Study Hematology Laboratory Tests Worst Common Terminology Criteria (CTC) Grade - Treated Participants | Lymphocytes Grade 3-4 (n=8, 5, 15, 6, 34) | 1 participants |
| Ipilimumab 3 mg/kg + XRT Combination Therapy | Number of Participants With On-Study Hematology Laboratory Tests Worst Common Terminology Criteria (CTC) Grade - Treated Participants | WBC Grade 1-4 (n=8, 5, 15, 6, 34) | 1 participants |
| Ipilimumab 3 mg/kg + XRT Combination Therapy | Number of Participants With On-Study Hematology Laboratory Tests Worst Common Terminology Criteria (CTC) Grade - Treated Participants | Neutrophils Grade 1-4 (n=8, 5, 15, 6, 34) | 1 participants |
| Ipilimumab 3 mg/kg + XRT Combination Therapy | Number of Participants With On-Study Hematology Laboratory Tests Worst Common Terminology Criteria (CTC) Grade - Treated Participants | Platelets Grade 3-4 (n=8, 5, 15, 6, 34) | 0 participants |
| Ipilimumab 3 mg/kg + XRT Combination Therapy | Number of Participants With On-Study Hematology Laboratory Tests Worst Common Terminology Criteria (CTC) Grade - Treated Participants | Hemoglobin Grade 3-4 (n=8, 5, 15, 6, 34) | 0 participants |
| Ipilimumab 3 mg/kg + XRT Combination Therapy | Number of Participants With On-Study Hematology Laboratory Tests Worst Common Terminology Criteria (CTC) Grade - Treated Participants | Lymphocytes Grade 1-4 (n=8, 5, 15, 6, 34) | 5 participants |
| Ipilimumab 3 mg/kg + XRT Combination Therapy | Number of Participants With On-Study Hematology Laboratory Tests Worst Common Terminology Criteria (CTC) Grade - Treated Participants | Hemoglobin Grade 1-4 (n=8, 5, 15, 6, 34) | 6 participants |
| Ipilimumab 3 mg/kg + XRT Combination Therapy | Number of Participants With On-Study Hematology Laboratory Tests Worst Common Terminology Criteria (CTC) Grade - Treated Participants | Neutrophils Grade 3-4 (n=8, 5, 15, 6, 34) | 0 participants |
| Ipilimumab 3 mg/kg + XRT Combination Therapy | Number of Participants With On-Study Hematology Laboratory Tests Worst Common Terminology Criteria (CTC) Grade - Treated Participants | Platelets Grade 1-4 (n=8, 5, 15, 6, 34) | 1 participants |
| Ipilimumab 10 mg/kg + XRT Combination | Number of Participants With On-Study Hematology Laboratory Tests Worst Common Terminology Criteria (CTC) Grade - Treated Participants | Neutrophils Grade 3-4 (n=8, 5, 15, 6, 34) | 0 participants |
| Ipilimumab 10 mg/kg + XRT Combination | Number of Participants With On-Study Hematology Laboratory Tests Worst Common Terminology Criteria (CTC) Grade - Treated Participants | Lymphocytes Grade 1-4 (n=8, 5, 15, 6, 34) | 31 participants |
| Ipilimumab 10 mg/kg + XRT Combination | Number of Participants With On-Study Hematology Laboratory Tests Worst Common Terminology Criteria (CTC) Grade - Treated Participants | Platelets Grade 1-4 (n=8, 5, 15, 6, 34) | 2 participants |
| Ipilimumab 10 mg/kg + XRT Combination | Number of Participants With On-Study Hematology Laboratory Tests Worst Common Terminology Criteria (CTC) Grade - Treated Participants | Platelets Grade 3-4 (n=8, 5, 15, 6, 34) | 0 participants |
| Ipilimumab 10 mg/kg + XRT Combination | Number of Participants With On-Study Hematology Laboratory Tests Worst Common Terminology Criteria (CTC) Grade - Treated Participants | Lymphocytes Grade 3-4 (n=8, 5, 15, 6, 34) | 3 participants |
| Ipilimumab 10 mg/kg + XRT Combination | Number of Participants With On-Study Hematology Laboratory Tests Worst Common Terminology Criteria (CTC) Grade - Treated Participants | Hemoglobin Grade 1-4 (n=8, 5, 15, 6, 34) | 28 participants |
| Ipilimumab 10 mg/kg + XRT Combination | Number of Participants With On-Study Hematology Laboratory Tests Worst Common Terminology Criteria (CTC) Grade - Treated Participants | WBC Grade 1-4 (n=8, 5, 15, 6, 34) | 2 participants |
| Ipilimumab 10 mg/kg + XRT Combination | Number of Participants With On-Study Hematology Laboratory Tests Worst Common Terminology Criteria (CTC) Grade - Treated Participants | Hemoglobin Grade 3-4 (n=8, 5, 15, 6, 34) | 6 participants |
| Ipilimumab 10 mg/kg + XRT Combination | Number of Participants With On-Study Hematology Laboratory Tests Worst Common Terminology Criteria (CTC) Grade - Treated Participants | Neutrophils Grade 1-4 (n=8, 5, 15, 6, 34) | 2 participants |
| Ipilimumab 10 mg/kg + XRT Combination | Number of Participants With On-Study Hematology Laboratory Tests Worst Common Terminology Criteria (CTC) Grade - Treated Participants | WBC Grade 3-4 (n=8, 5, 15, 6, 34) | 0 participants |
Secondary
Number of Participants With On-Study Serum Chemistry Laboratory Tests Worst Common Terminology Criteria (CTC) Grade - Treated Participants
CTC v3.0 used. On-study serum chemistry laboratories were reported after first dose date, every 21 days during a treatment cycle, and within 70 days of last dose of study therapy (ie, Days 1, 22, 43, 64, 85, etc). Alanine Aminotransferase (ALT) Units per Liter (U/L) Gr 1: \> 1.0 - 2.5 \* upper limits of normal (ULN); Gr 2: \> 2.5 - 5.0 \* ULN; Gr 3: \> 5.0 - 20.0 \* ULN; Gr 4: \> 20.0 \* ULN. Aspartate Aminotransferase (AST) U/L: Gr 1: \> 1.0 - 2.5 \* ULN; Gr 2: \> 2.5 - 5.0 \* ULN; Gr 3: \> 5.0 - 20.0 \* ULN; Gr 4: \> 20.0 \* ULN. Total Bilirubin micromoles per liter (µmol/L): Gr 1: \> 1.0 - 1.5 \* ULN; Gr 2: \> 1.5 - 3.0 \* ULN; Gr 3: \> 3.0 - 10.0 \* ULN; Gr 4: \> 10.0 \* ULN. Alkaline Phosphatase U/L: Gr 1: \> 1.0 - 2.5 \* ULN; Gr 2: \> 2.5 - 5.0 \* ULN; Gr 3: \> 5.0 - 20.0 \* ULN; Gr 4: \> 20.0 \* ULN. Amylase U/L: Gr1: \> 1.0 - 1.5 \* ULN; Gr 2: \> 1.5 - 2.0 \* ULN; Gr 3: \> 2.0 - 5.0 \* ULN; Gr4: \> 5.0 \* ULN. Creatinine µmol/L: Gr1: \> 1.0 - 1.5\*ULN; Gr2: \> 1.5 - 3.0\*ULN; Gr3: \> 3.0 - 6.0\*ULN; Gr4: \> 6.0\*ULN.
Time frame: Day 1 to last day of study treatment (+70 days) up to 2 years
Population: All participants in the study who received either ipilimumab or radiation and had a laboratory measurement were analyzed.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Ipilimumab Monotherapy 3 mg/kg | Number of Participants With On-Study Serum Chemistry Laboratory Tests Worst Common Terminology Criteria (CTC) Grade - Treated Participants | Amylase Grade 1-4 (n=8,5,15,6,34) | 2 participants |
| Ipilimumab Monotherapy 3 mg/kg | Number of Participants With On-Study Serum Chemistry Laboratory Tests Worst Common Terminology Criteria (CTC) Grade - Treated Participants | Bilirubin Grade 3-4 (n=8,5,15,6,34) | 0 participants |
| Ipilimumab Monotherapy 3 mg/kg | Number of Participants With On-Study Serum Chemistry Laboratory Tests Worst Common Terminology Criteria (CTC) Grade - Treated Participants | Phosphatase Grade 3-4 (n=8,5,15,6,34) | 0 participants |
| Ipilimumab Monotherapy 3 mg/kg | Number of Participants With On-Study Serum Chemistry Laboratory Tests Worst Common Terminology Criteria (CTC) Grade - Treated Participants | Phosphatase Grade 1-4 (n=8,5,15,6,34) | 3 participants |
| Ipilimumab Monotherapy 3 mg/kg | Number of Participants With On-Study Serum Chemistry Laboratory Tests Worst Common Terminology Criteria (CTC) Grade - Treated Participants | ALT Grade 3-4 (n=8,5,15,6,34) | 0 participants |
| Ipilimumab Monotherapy 3 mg/kg | Number of Participants With On-Study Serum Chemistry Laboratory Tests Worst Common Terminology Criteria (CTC) Grade - Treated Participants | AST Grade 1-4 (n=8,5,15,6,34) | 0 participants |
| Ipilimumab Monotherapy 3 mg/kg | Number of Participants With On-Study Serum Chemistry Laboratory Tests Worst Common Terminology Criteria (CTC) Grade - Treated Participants | ALT Grade 1-4 (n=8,5,15,6,34) | 0 participants |
| Ipilimumab Monotherapy 3 mg/kg | Number of Participants With On-Study Serum Chemistry Laboratory Tests Worst Common Terminology Criteria (CTC) Grade - Treated Participants | Creatinine Grade 1-4 (n=8,5,15,6,34) | 0 participants |
| Ipilimumab Monotherapy 3 mg/kg | Number of Participants With On-Study Serum Chemistry Laboratory Tests Worst Common Terminology Criteria (CTC) Grade - Treated Participants | AST Grade 3-4 (n=8,5,15,6,34) | 0 participants |
| Ipilimumab Monotherapy 3 mg/kg | Number of Participants With On-Study Serum Chemistry Laboratory Tests Worst Common Terminology Criteria (CTC) Grade - Treated Participants | Amylase Grade 3-4 (n=8,5,15,6,34) | 0 participants |
| Ipilimumab Monotherapy 3 mg/kg | Number of Participants With On-Study Serum Chemistry Laboratory Tests Worst Common Terminology Criteria (CTC) Grade - Treated Participants | Bilirubin Grade 1-4 (n=8,5,15,6,34) | 0 participants |
| Ipilimumab Monotherapy 3 mg/kg | Number of Participants With On-Study Serum Chemistry Laboratory Tests Worst Common Terminology Criteria (CTC) Grade - Treated Participants | Creatinine Grade 3-4 (n=8,5,15,6,34) | 0 participants |
| Ipilimumab Monotherapy 5 mg/kg | Number of Participants With On-Study Serum Chemistry Laboratory Tests Worst Common Terminology Criteria (CTC) Grade - Treated Participants | Bilirubin Grade 1-4 (n=8,5,15,6,34) | 0 participants |
| Ipilimumab Monotherapy 5 mg/kg | Number of Participants With On-Study Serum Chemistry Laboratory Tests Worst Common Terminology Criteria (CTC) Grade - Treated Participants | Amylase Grade 1-4 (n=8,5,15,6,34) | 3 participants |
| Ipilimumab Monotherapy 5 mg/kg | Number of Participants With On-Study Serum Chemistry Laboratory Tests Worst Common Terminology Criteria (CTC) Grade - Treated Participants | Bilirubin Grade 3-4 (n=8,5,15,6,34) | 0 participants |
| Ipilimumab Monotherapy 5 mg/kg | Number of Participants With On-Study Serum Chemistry Laboratory Tests Worst Common Terminology Criteria (CTC) Grade - Treated Participants | ALT Grade 3-4 (n=8,5,15,6,34) | 1 participants |
| Ipilimumab Monotherapy 5 mg/kg | Number of Participants With On-Study Serum Chemistry Laboratory Tests Worst Common Terminology Criteria (CTC) Grade - Treated Participants | Amylase Grade 3-4 (n=8,5,15,6,34) | 0 participants |
| Ipilimumab Monotherapy 5 mg/kg | Number of Participants With On-Study Serum Chemistry Laboratory Tests Worst Common Terminology Criteria (CTC) Grade - Treated Participants | Phosphatase Grade 1-4 (n=8,5,15,6,34) | 4 participants |
| Ipilimumab Monotherapy 5 mg/kg | Number of Participants With On-Study Serum Chemistry Laboratory Tests Worst Common Terminology Criteria (CTC) Grade - Treated Participants | Phosphatase Grade 3-4 (n=8,5,15,6,34) | 0 participants |
| Ipilimumab Monotherapy 5 mg/kg | Number of Participants With On-Study Serum Chemistry Laboratory Tests Worst Common Terminology Criteria (CTC) Grade - Treated Participants | ALT Grade 1-4 (n=8,5,15,6,34) | 2 participants |
| Ipilimumab Monotherapy 5 mg/kg | Number of Participants With On-Study Serum Chemistry Laboratory Tests Worst Common Terminology Criteria (CTC) Grade - Treated Participants | AST Grade 3-4 (n=8,5,15,6,34) | 1 participants |
| Ipilimumab Monotherapy 5 mg/kg | Number of Participants With On-Study Serum Chemistry Laboratory Tests Worst Common Terminology Criteria (CTC) Grade - Treated Participants | Creatinine Grade 1-4 (n=8,5,15,6,34) | 0 participants |
| Ipilimumab Monotherapy 5 mg/kg | Number of Participants With On-Study Serum Chemistry Laboratory Tests Worst Common Terminology Criteria (CTC) Grade - Treated Participants | Creatinine Grade 3-4 (n=8,5,15,6,34) | 0 participants |
| Ipilimumab Monotherapy 5 mg/kg | Number of Participants With On-Study Serum Chemistry Laboratory Tests Worst Common Terminology Criteria (CTC) Grade - Treated Participants | AST Grade 1-4 (n=8,5,15,6,34) | 2 participants |
| Ipilimumab Monotherapy 10 mg/kg | Number of Participants With On-Study Serum Chemistry Laboratory Tests Worst Common Terminology Criteria (CTC) Grade - Treated Participants | Creatinine Grade 1-4 (n=8,5,15,6,34) | 4 participants |
| Ipilimumab Monotherapy 10 mg/kg | Number of Participants With On-Study Serum Chemistry Laboratory Tests Worst Common Terminology Criteria (CTC) Grade - Treated Participants | ALT Grade 1-4 (n=8,5,15,6,34) | 7 participants |
| Ipilimumab Monotherapy 10 mg/kg | Number of Participants With On-Study Serum Chemistry Laboratory Tests Worst Common Terminology Criteria (CTC) Grade - Treated Participants | ALT Grade 3-4 (n=8,5,15,6,34) | 2 participants |
| Ipilimumab Monotherapy 10 mg/kg | Number of Participants With On-Study Serum Chemistry Laboratory Tests Worst Common Terminology Criteria (CTC) Grade - Treated Participants | AST Grade 1-4 (n=8,5,15,6,34) | 6 participants |
| Ipilimumab Monotherapy 10 mg/kg | Number of Participants With On-Study Serum Chemistry Laboratory Tests Worst Common Terminology Criteria (CTC) Grade - Treated Participants | AST Grade 3-4 (n=8,5,15,6,34) | 2 participants |
| Ipilimumab Monotherapy 10 mg/kg | Number of Participants With On-Study Serum Chemistry Laboratory Tests Worst Common Terminology Criteria (CTC) Grade - Treated Participants | Bilirubin Grade 1-4 (n=8,5,15,6,34) | 2 participants |
| Ipilimumab Monotherapy 10 mg/kg | Number of Participants With On-Study Serum Chemistry Laboratory Tests Worst Common Terminology Criteria (CTC) Grade - Treated Participants | Bilirubin Grade 3-4 (n=8,5,15,6,34) | 0 participants |
| Ipilimumab Monotherapy 10 mg/kg | Number of Participants With On-Study Serum Chemistry Laboratory Tests Worst Common Terminology Criteria (CTC) Grade - Treated Participants | Phosphatase Grade 1-4 (n=8,5,15,6,34) | 7 participants |
| Ipilimumab Monotherapy 10 mg/kg | Number of Participants With On-Study Serum Chemistry Laboratory Tests Worst Common Terminology Criteria (CTC) Grade - Treated Participants | Phosphatase Grade 3-4 (n=8,5,15,6,34) | 1 participants |
| Ipilimumab Monotherapy 10 mg/kg | Number of Participants With On-Study Serum Chemistry Laboratory Tests Worst Common Terminology Criteria (CTC) Grade - Treated Participants | Amylase Grade 1-4 (n=8,5,15,6,34) | 4 participants |
| Ipilimumab Monotherapy 10 mg/kg | Number of Participants With On-Study Serum Chemistry Laboratory Tests Worst Common Terminology Criteria (CTC) Grade - Treated Participants | Amylase Grade 3-4 (n=8,5,15,6,34) | 0 participants |
| Ipilimumab Monotherapy 10 mg/kg | Number of Participants With On-Study Serum Chemistry Laboratory Tests Worst Common Terminology Criteria (CTC) Grade - Treated Participants | Creatinine Grade 3-4 (n=8,5,15,6,34) | 0 participants |
| Ipilimumab 3 mg/kg + XRT Combination Therapy | Number of Participants With On-Study Serum Chemistry Laboratory Tests Worst Common Terminology Criteria (CTC) Grade - Treated Participants | Bilirubin Grade 3-4 (n=8,5,15,6,34) | 0 participants |
| Ipilimumab 3 mg/kg + XRT Combination Therapy | Number of Participants With On-Study Serum Chemistry Laboratory Tests Worst Common Terminology Criteria (CTC) Grade - Treated Participants | ALT Grade 1-4 (n=8,5,15,6,34) | 2 participants |
| Ipilimumab 3 mg/kg + XRT Combination Therapy | Number of Participants With On-Study Serum Chemistry Laboratory Tests Worst Common Terminology Criteria (CTC) Grade - Treated Participants | Phosphatase Grade 3-4 (n=8,5,15,6,34) | 1 participants |
| Ipilimumab 3 mg/kg + XRT Combination Therapy | Number of Participants With On-Study Serum Chemistry Laboratory Tests Worst Common Terminology Criteria (CTC) Grade - Treated Participants | Bilirubin Grade 1-4 (n=8,5,15,6,34) | 1 participants |
| Ipilimumab 3 mg/kg + XRT Combination Therapy | Number of Participants With On-Study Serum Chemistry Laboratory Tests Worst Common Terminology Criteria (CTC) Grade - Treated Participants | Amylase Grade 1-4 (n=8,5,15,6,34) | 0 participants |
| Ipilimumab 3 mg/kg + XRT Combination Therapy | Number of Participants With On-Study Serum Chemistry Laboratory Tests Worst Common Terminology Criteria (CTC) Grade - Treated Participants | AST Grade 3-4 (n=8,5,15,6,34) | 0 participants |
| Ipilimumab 3 mg/kg + XRT Combination Therapy | Number of Participants With On-Study Serum Chemistry Laboratory Tests Worst Common Terminology Criteria (CTC) Grade - Treated Participants | Creatinine Grade 3-4 (n=8,5,15,6,34) | 0 participants |
| Ipilimumab 3 mg/kg + XRT Combination Therapy | Number of Participants With On-Study Serum Chemistry Laboratory Tests Worst Common Terminology Criteria (CTC) Grade - Treated Participants | Amylase Grade 3-4 (n=8,5,15,6,34) | 0 participants |
| Ipilimumab 3 mg/kg + XRT Combination Therapy | Number of Participants With On-Study Serum Chemistry Laboratory Tests Worst Common Terminology Criteria (CTC) Grade - Treated Participants | AST Grade 1-4 (n=8,5,15,6,34) | 2 participants |
| Ipilimumab 3 mg/kg + XRT Combination Therapy | Number of Participants With On-Study Serum Chemistry Laboratory Tests Worst Common Terminology Criteria (CTC) Grade - Treated Participants | ALT Grade 3-4 (n=8,5,15,6,34) | 0 participants |
| Ipilimumab 3 mg/kg + XRT Combination Therapy | Number of Participants With On-Study Serum Chemistry Laboratory Tests Worst Common Terminology Criteria (CTC) Grade - Treated Participants | Creatinine Grade 1-4 (n=8,5,15,6,34) | 1 participants |
| Ipilimumab 3 mg/kg + XRT Combination Therapy | Number of Participants With On-Study Serum Chemistry Laboratory Tests Worst Common Terminology Criteria (CTC) Grade - Treated Participants | Phosphatase Grade 1-4 (n=8,5,15,6,34) | 5 participants |
| Ipilimumab 10 mg/kg + XRT Combination | Number of Participants With On-Study Serum Chemistry Laboratory Tests Worst Common Terminology Criteria (CTC) Grade - Treated Participants | Bilirubin Grade 3-4 (n=8,5,15,6,34) | 0 participants |
| Ipilimumab 10 mg/kg + XRT Combination | Number of Participants With On-Study Serum Chemistry Laboratory Tests Worst Common Terminology Criteria (CTC) Grade - Treated Participants | Amylase Grade 3-4 (n=8,5,15,6,34) | 1 participants |
| Ipilimumab 10 mg/kg + XRT Combination | Number of Participants With On-Study Serum Chemistry Laboratory Tests Worst Common Terminology Criteria (CTC) Grade - Treated Participants | ALT Grade 1-4 (n=8,5,15,6,34) | 10 participants |
| Ipilimumab 10 mg/kg + XRT Combination | Number of Participants With On-Study Serum Chemistry Laboratory Tests Worst Common Terminology Criteria (CTC) Grade - Treated Participants | Phosphatase Grade 3-4 (n=8,5,15,6,34) | 5 participants |
| Ipilimumab 10 mg/kg + XRT Combination | Number of Participants With On-Study Serum Chemistry Laboratory Tests Worst Common Terminology Criteria (CTC) Grade - Treated Participants | ALT Grade 3-4 (n=8,5,15,6,34) | 1 participants |
| Ipilimumab 10 mg/kg + XRT Combination | Number of Participants With On-Study Serum Chemistry Laboratory Tests Worst Common Terminology Criteria (CTC) Grade - Treated Participants | AST Grade 3-4 (n=8,5,15,6,34) | 0 participants |
| Ipilimumab 10 mg/kg + XRT Combination | Number of Participants With On-Study Serum Chemistry Laboratory Tests Worst Common Terminology Criteria (CTC) Grade - Treated Participants | Creatinine Grade 3-4 (n=8,5,15,6,34) | 0 participants |
| Ipilimumab 10 mg/kg + XRT Combination | Number of Participants With On-Study Serum Chemistry Laboratory Tests Worst Common Terminology Criteria (CTC) Grade - Treated Participants | Bilirubin Grade 1-4 (n=8,5,15,6,34) | 1 participants |
| Ipilimumab 10 mg/kg + XRT Combination | Number of Participants With On-Study Serum Chemistry Laboratory Tests Worst Common Terminology Criteria (CTC) Grade - Treated Participants | Amylase Grade 1-4 (n=8,5,15,6,34) | 4 participants |
| Ipilimumab 10 mg/kg + XRT Combination | Number of Participants With On-Study Serum Chemistry Laboratory Tests Worst Common Terminology Criteria (CTC) Grade - Treated Participants | Phosphatase Grade 1-4 (n=8,5,15,6,34) | 21 participants |
| Ipilimumab 10 mg/kg + XRT Combination | Number of Participants With On-Study Serum Chemistry Laboratory Tests Worst Common Terminology Criteria (CTC) Grade - Treated Participants | AST Grade 1-4 (n=8,5,15,6,34) | 8 participants |
| Ipilimumab 10 mg/kg + XRT Combination | Number of Participants With On-Study Serum Chemistry Laboratory Tests Worst Common Terminology Criteria (CTC) Grade - Treated Participants | Creatinine Grade 1-4 (n=8,5,15,6,34) | 5 participants |
Secondary
Overall Survival at Completion of Follow Up Period - Treated Participants
Overall Survival (OS) was defined as the time from the first date of study treatment until the date of death and was measured in months. For those participants who have not died, OS was censored at the last date the participant was known to be alive. Completion of follow-up for OS was a minimum time of eligibility 54 months to a maximum of 85 months.
Time frame: Day 1 to 5 years post treatment
Population: All participants in cohorts with monotherapy and with radiotherapy who received any ipilimumab were analyzed.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Ipilimumab Monotherapy 3 mg/kg | Overall Survival at Completion of Follow Up Period - Treated Participants | 22.5 Months |
| Ipilimumab Monotherapy 5 mg/kg | Overall Survival at Completion of Follow Up Period - Treated Participants | 36.3 Months |
| Ipilimumab Monotherapy 10 mg/kg | Overall Survival at Completion of Follow Up Period - Treated Participants | 26.6 Months |
| Ipilimumab 3 mg/kg + XRT Combination Therapy | Overall Survival at Completion of Follow Up Period - Treated Participants | 18.2 Months |
| Ipilimumab 10 mg/kg + XRT Combination | Overall Survival at Completion of Follow Up Period - Treated Participants | 9.7 Months |
| Ipilimumab 10 mg/kg + XRT Combination (Chemotherapy Naive) | Overall Survival at Completion of Follow Up Period - Treated Participants | 17.4 Months |
Secondary
Overall Tumor Response Rate in 10 mg/kg Ipilimumab Monotherapy and Ipilimumab/XRT Combination Therapy
Tumor response rate was defined as the number of participants with a best response of partial or complete response divided by the total number of tumor evaluable participants. Overall Tumor Response was defined as participants with a tumor response of CR or PR at anytime during the study. CR=Disappearance of all target lesions; PR=At least a 30% decrease in the sum of the longest diameter (LD) of target lesions taking as reference, baseline sum LD. For a status of CR or PR, changes in tumor measurements were confirmed by repeat studies no less than 4 weeks after the criteria for response were first met
Time frame: Day 1 to last day of study treatment (+70 days) up to 2 years
Population: All participants in cohorts with 10 mg/kg ipilimumab monotherapy and with 10 mg/kg ipilimumab combination therapy with XRT who received any ipilimumab and had a baseline PSA, were analyzed.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Ipilimumab Monotherapy 3 mg/kg | Overall Tumor Response Rate in 10 mg/kg Ipilimumab Monotherapy and Ipilimumab/XRT Combination Therapy | 12.5 percentage of participants |
| Ipilimumab Monotherapy 5 mg/kg | Overall Tumor Response Rate in 10 mg/kg Ipilimumab Monotherapy and Ipilimumab/XRT Combination Therapy | 0 percentage of participants |
| Ipilimumab Monotherapy 10 mg/kg | Overall Tumor Response Rate in 10 mg/kg Ipilimumab Monotherapy and Ipilimumab/XRT Combination Therapy | 0 percentage of participants |
Secondary
PSA Response Rate at Day 85 and Overall PSA Response Rate in 10 mg/kg Monotherapy and Combination Therapy
PSA response rate was defined as the number of participants with a PSA response (PR or CR) divided by the total number of PSA evaluable participants. PSA response at Day 85, as reported by the investigator, was defined as a PSA concentration \< 50% of the PSA reference value occurring on or before Day 85 and this response was confirmed at least 4 weeks after the first determination. The PSA reference value was the PSA concentration measured immediately prior to treatment. Overall Response is \< 50% of the PSA reference value occurring anytime after treatment was initiated and this response was confirmed at least 4 weeks after the first determination. Complete response=PSA concentration \< 2 ng/mL, confirmed at least 4 weeks after first value; Partial response=PSA concentration ≤ 50% of PSA reference value, confirmed at least 4 weeks after first determination.
Time frame: Day 85, Day 1 to last day of study treatment (+70 days) up to 2 years
Population: All participants in cohorts with 10 mg/kg ipilimumab monotherapy and with 10 mg/kg ipilimumab combination therapy with XRT who received any ipilimumab and had a baseline PSA, were analyzed.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Ipilimumab Monotherapy 3 mg/kg | PSA Response Rate at Day 85 and Overall PSA Response Rate in 10 mg/kg Monotherapy and Combination Therapy | PSA Response Rate at Day 85 | 18.8 percentage of participants |
| Ipilimumab Monotherapy 3 mg/kg | PSA Response Rate at Day 85 and Overall PSA Response Rate in 10 mg/kg Monotherapy and Combination Therapy | Overall PSA Response Rate | 25.0 percentage of participants |
| Ipilimumab Monotherapy 5 mg/kg | PSA Response Rate at Day 85 and Overall PSA Response Rate in 10 mg/kg Monotherapy and Combination Therapy | PSA Response Rate at Day 85 | 9.5 percentage of participants |
| Ipilimumab Monotherapy 5 mg/kg | PSA Response Rate at Day 85 and Overall PSA Response Rate in 10 mg/kg Monotherapy and Combination Therapy | Overall PSA Response Rate | 9.5 percentage of participants |
| Ipilimumab Monotherapy 10 mg/kg | PSA Response Rate at Day 85 and Overall PSA Response Rate in 10 mg/kg Monotherapy and Combination Therapy | PSA Response Rate at Day 85 | 15.4 percentage of participants |
| Ipilimumab Monotherapy 10 mg/kg | PSA Response Rate at Day 85 and Overall PSA Response Rate in 10 mg/kg Monotherapy and Combination Therapy | Overall PSA Response Rate | 15.4 percentage of participants |
Secondary
Time to PSA Response at Day 85 in Participants With Complete Response (CR) or Confirmed Partial Response (PR) at Day 85
Time to PSA response was measured in months. Time to PSA response was analyzed in those participants with CR or PR at Day 85. CR=PSA concentration \< 2 ng/mL, confirmed at least 4 weeks after 1st value; PR=PSA concentration ≤ 50% of PSA reference, confirmed at least 4 weeks after 1st value.
Time frame: Day 1 to Day 85
Population: All participants in cohorts with monotherapy and with radiotherapy who received any ipilimumab, had a baseline PSA, and had a confirmed Complete Response (CR) or Partial Response (PR) at Day 85.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Ipilimumab Monotherapy 3 mg/kg | Time to PSA Response at Day 85 in Participants With Complete Response (CR) or Confirmed Partial Response (PR) at Day 85 | 1.41 Months |
| Ipilimumab Monotherapy 5 mg/kg | Time to PSA Response at Day 85 in Participants With Complete Response (CR) or Confirmed Partial Response (PR) at Day 85 | 1.54 Months |
| Ipilimumab Monotherapy 10 mg/kg | Time to PSA Response at Day 85 in Participants With Complete Response (CR) or Confirmed Partial Response (PR) at Day 85 | 1.4 Months |
| Ipilimumab 10 mg/kg + XRT Combination | Time to PSA Response at Day 85 in Participants With Complete Response (CR) or Confirmed Partial Response (PR) at Day 85 | 1.1 Months |
| Ipilimumab 10 mg/kg + XRT Combination (Chemotherapy Naive) | Time to PSA Response at Day 85 in Participants With Complete Response (CR) or Confirmed Partial Response (PR) at Day 85 | 1.1 Months |