Trial Outcomes & Findings for Evaluation of Tumor Response to Ipilimumab in the Treatment of Melanoma With Brain Metastases (NCT NCT00623766)
NCT ID: NCT00623766
Last Updated: 2014-06-09
Results Overview
Disease control rate is defined as the number of patients with a best overall response of complete response (CR), partial response (PR), or stable disease (SD) (global, in brain, or outside of brain) based on mWHO criteria divided by the number of patients who received treatment. By mWHO criteria: CR=complete disappearance of all index lesions. PR=decrease, relative to baseline, of 50% or greater in the sum of the 2 largest perpendicular diameters of all index lesions. SD=does not meet criteria for CR or PR, in the absence of progressive disease (PD). Patients with PR or CR not confirmed after at least 4 weeks are scored as SD unless they have new primary lesions. PD=at least 25% increase in the sum of the diameters of all index lesions (taking as reference the smallest sum recorded at or following baseline) and/or the appearance of any new lesions. CNS=central nervous system.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
99 participants
Primary outcome timeframe
From Day 1, first dose to end of Week 12
Results posted on
2014-06-09
Participant Flow
A total of 99 participants were enrolled, and 27 did not receive treatment because they did not meet screening criteria.
Participant milestones
| Measure |
Ipilimumab, 10 mg/kg IV, in Corticosteroid-free Patients
Participants who had not received corticosteroid therapy for at least 10 days before starting study drug received ipilimumab,10 mg/kg, as a 90-minute intravenous (IV) infusion every 3 weeks (Weeks 1, 4, 7, and 10) during the Induction Phase. Those eligible (patients who did not discontinue due to toxicity, did not show progression at 24 weeks, and who remained clinically stable) for the Maintenance Phase continued to receive ipilimumab, 10 mg/kg IV every 12 weeks, beginning at Week 24.
|
Ipilimumab, 10 mg/kg IV, in Corticosteroid-dependent Patients
Participants who required concurrent systemic corticosteroid therapy for adequate control of neurologic signs and symptoms related to metastatic brain lesion received ipilimumab,10 mg/kg, as a 90-minute IV infusion every 3 weeks (Weeks 1, 4, 7, and 10) during the Induction Phase. Those eligible (patients who did not discontinue due to toxicity, did not show progression at 24 weeks, and who remained clinically stable) for the Maintenance Phase continued to receive ipilimumab, 10 mg/kg IV every 12 weeks, beginning at Week 24.
|
|---|---|---|
|
Induction Phase (Day 1 to Week 24)
STARTED
|
51
|
21
|
|
Induction Phase (Day 1 to Week 24)
COMPLETED
|
15
|
5
|
|
Induction Phase (Day 1 to Week 24)
NOT COMPLETED
|
36
|
16
|
|
Maintenance Phase (Week 24 to Year 2)
STARTED
|
11
|
2
|
|
Maintenance Phase (Week 24 to Year 2)
COMPLETED
|
1
|
0
|
|
Maintenance Phase (Week 24 to Year 2)
NOT COMPLETED
|
10
|
2
|
Reasons for withdrawal
| Measure |
Ipilimumab, 10 mg/kg IV, in Corticosteroid-free Patients
Participants who had not received corticosteroid therapy for at least 10 days before starting study drug received ipilimumab,10 mg/kg, as a 90-minute intravenous (IV) infusion every 3 weeks (Weeks 1, 4, 7, and 10) during the Induction Phase. Those eligible (patients who did not discontinue due to toxicity, did not show progression at 24 weeks, and who remained clinically stable) for the Maintenance Phase continued to receive ipilimumab, 10 mg/kg IV every 12 weeks, beginning at Week 24.
|
Ipilimumab, 10 mg/kg IV, in Corticosteroid-dependent Patients
Participants who required concurrent systemic corticosteroid therapy for adequate control of neurologic signs and symptoms related to metastatic brain lesion received ipilimumab,10 mg/kg, as a 90-minute IV infusion every 3 weeks (Weeks 1, 4, 7, and 10) during the Induction Phase. Those eligible (patients who did not discontinue due to toxicity, did not show progression at 24 weeks, and who remained clinically stable) for the Maintenance Phase continued to receive ipilimumab, 10 mg/kg IV every 12 weeks, beginning at Week 24.
|
|---|---|---|
|
Induction Phase (Day 1 to Week 24)
Off treatment
|
36
|
16
|
|
Maintenance Phase (Week 24 to Year 2)
Disease progression
|
4
|
0
|
|
Maintenance Phase (Week 24 to Year 2)
Administrative reason by sponsor
|
4
|
0
|
|
Maintenance Phase (Week 24 to Year 2)
Withdrawal by Subject
|
1
|
2
|
|
Maintenance Phase (Week 24 to Year 2)
Patient required surgery
|
1
|
0
|
Baseline Characteristics
Evaluation of Tumor Response to Ipilimumab in the Treatment of Melanoma With Brain Metastases
Baseline characteristics by cohort
| Measure |
Ipilimumab, 10 mg/kg IV, in Corticosteroid-free Patients
n=51 Participants
Participants who had not received corticosteroid therapy for at least 10 days before starting study drug received ipilimumab,10 mg/kg, as a 90-minute intravenous (IV) infusion every 3 weeks (Weeks 1, 4, 7, and 10) during the Induction Phase. Those eligible (patients who did not discontinue due to toxicity, did not show progression at 24 weeks, and who remained clinically stable) for the Maintenance Phase continued to receive ipilimumab, 10 mg/kg IV every 12 weeks, beginning at Week 24.
|
Ipilimumab, 10 mg/kg IV, in Corticosteroid-dependent Patients
n=21 Participants
Participants who were dependent on corticosteroid therapy received ipilimumab,10 mg/kg, as a 90-minute IV infusion every 3 weeks (Weeks 1, 4, 7, and 10) during the Induction Phase. Those eligible (patients who did not discontinue due to toxicity, did not show progression at 24 weeks, and who remained clinically stable) for the Maintenance Phase continued to receive ipilimumab, 10 mg/kg IV every 12 weeks, beginning at Week 24.
|
Total
n=72 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
Younger than 65 years
|
39 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
56 Participants
n=5 Participants
|
|
Age, Customized
65 years and older
|
12 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
18 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
33 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
44 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
51 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
72 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Eastern Cooperative Oncology Group (ECOG) score
0
|
25 Units on a scale
n=5 Participants
|
14 Units on a scale
n=7 Participants
|
39 Units on a scale
n=5 Participants
|
|
Eastern Cooperative Oncology Group (ECOG) score
1
|
26 Units on a scale
n=5 Participants
|
7 Units on a scale
n=7 Participants
|
33 Units on a scale
n=5 Participants
|
PRIMARY outcome
Timeframe: From Day 1, first dose to end of Week 12Population: All participants who received at least 1 dose of ipilimumab
Disease control rate is defined as the number of patients with a best overall response of complete response (CR), partial response (PR), or stable disease (SD) (global, in brain, or outside of brain) based on mWHO criteria divided by the number of patients who received treatment. By mWHO criteria: CR=complete disappearance of all index lesions. PR=decrease, relative to baseline, of 50% or greater in the sum of the 2 largest perpendicular diameters of all index lesions. SD=does not meet criteria for CR or PR, in the absence of progressive disease (PD). Patients with PR or CR not confirmed after at least 4 weeks are scored as SD unless they have new primary lesions. PD=at least 25% increase in the sum of the diameters of all index lesions (taking as reference the smallest sum recorded at or following baseline) and/or the appearance of any new lesions. CNS=central nervous system.
Outcome measures
| Measure |
Ipilimumab, 10 mg/kg IV, in Corticosteroid-free Patients
n=51 Participants
Participants who had not received corticosteroid therapy for at least 10 days before starting study drug received ipilimumab,10 mg/kg, as a 90-minute intravenous (IV) infusion every 3 weeks (Weeks 1, 4, 7, and 10) during the Induction Phase. Those eligible (patients who did not discontinue due to toxicity, did not show progression at 24 weeks, and who remained clinically stable) for the Maintenance Phase continued to receive ipilimumab, 10 mg/kg IV every 12 weeks, beginning at Week 24.
|
Ipilimumab, 10 mg/kg IV, in Corticosteroid-dependent Patients
n=21 Participants
Participants who required concurrent systemic corticosteroid therapy for adequate control of neurologic signs and symptoms related to metastatic brain lesion received ipilimumab,10 mg/kg, as a 90-minute IV infusion every 3 weeks (Weeks 1, 4, 7, and 10) during the Induction Phase. Those eligible (patients who did not discontinue due to toxicity, did not show progression at 24 weeks, and who remained clinically stable) for the Maintenance Phase continued to receive ipilimumab, 10 mg/kg IV every 12 weeks, beginning at Week 24.
|
|---|---|---|
|
Disease Control Rate by Modified World Health Organization (mWHO) Tumor Assessment Criteria
Global disease control rate
|
17.6 Percentage of participants
Interval 8.4 to 30.9
|
4.8 Percentage of participants
Interval 0.1 to 23.8
|
|
Disease Control Rate by Modified World Health Organization (mWHO) Tumor Assessment Criteria
Disease control rate in brain
|
23.5 Percentage of participants
Interval 12.8 to 37.5
|
9.5 Percentage of participants
Interval 1.2 to 30.4
|
SECONDARY outcome
Timeframe: From Day 1, first dose to end of Week 12Population: All participants who received at least 1 dose of ipilimumab
Disease control rate is defined as the number of patients with a best overall response of immune-related (ir) complete response (irCR), partial response (irPR), or stable disease (irSD) divided by the total number of patients who received treatment. By irRC definition: irCR=complete disappearance of all index lesions. irPR=decrease, relative to baseline, of 50% or greater in the sum of the products of the 2 largest perpendicular diameters of all index lesions. irSD=does not meet criteria for irCR or irPR, in the absence of ir progressive disease (irPD). irPD=at least 25% increase in the sum of the products of all index lesions (taking as reference the smallest sum recorded at or following baseline). CNS=central nervous system; non-CNS compartment=extracranial, or outside of the brain.
Outcome measures
| Measure |
Ipilimumab, 10 mg/kg IV, in Corticosteroid-free Patients
n=51 Participants
Participants who had not received corticosteroid therapy for at least 10 days before starting study drug received ipilimumab,10 mg/kg, as a 90-minute intravenous (IV) infusion every 3 weeks (Weeks 1, 4, 7, and 10) during the Induction Phase. Those eligible (patients who did not discontinue due to toxicity, did not show progression at 24 weeks, and who remained clinically stable) for the Maintenance Phase continued to receive ipilimumab, 10 mg/kg IV every 12 weeks, beginning at Week 24.
|
Ipilimumab, 10 mg/kg IV, in Corticosteroid-dependent Patients
n=21 Participants
Participants who required concurrent systemic corticosteroid therapy for adequate control of neurologic signs and symptoms related to metastatic brain lesion received ipilimumab,10 mg/kg, as a 90-minute IV infusion every 3 weeks (Weeks 1, 4, 7, and 10) during the Induction Phase. Those eligible (patients who did not discontinue due to toxicity, did not show progression at 24 weeks, and who remained clinically stable) for the Maintenance Phase continued to receive ipilimumab, 10 mg/kg IV every 12 weeks, beginning at Week 24.
|
|---|---|---|
|
Disease Control Rate by Immune-related Response Criteria (irRC)
Global disease control rate
|
25.5 Percentage of participants
Interval 14.3 to 39.6
|
9.5 Percentage of participants
Interval 1.2 to 30.4
|
|
Disease Control Rate by Immune-related Response Criteria (irRC)
Disease control rate in brain lesions
|
25.5 Percentage of participants
Interval 14.3 to 39.6
|
9.5 Percentage of participants
Interval 1.2 to 30.4
|
|
Disease Control Rate by Immune-related Response Criteria (irRC)
Disease control rate in non-CNS compartment
|
33.3 Percentage of participants
Interval 20.8 to 47.9
|
9.5 Percentage of participants
Interval 1.2 to 30.4
|
SECONDARY outcome
Timeframe: From Day 1, first dose until the last tumor assessment, Week 12Population: All participants who received at least 1 dose of ipilimumab
BORR is defined as the number of patients whose global best overall response (BOR) was complete (CR) or partial response (PR), divided by the total number of participants who received treatment. CR=complete disappearance of all index lesions. PR=decrease, relative to baseline, of 50% or greater in the sum of the products of the 2 largest perpendicular diameters of all index lesions. The global BOR is the best overall response (OR) designation over the study as a whole for an individual in the study based on overall tumor burden. Both central nervous system (CNS) (brain lesions) and non-CNS compartments (lesions outside the brain) are considered for the global BOR. For the analysis of global BOR of CR or PR (by both modified WHO criteria and immune-related response criteria \[irRC\]), the OR assessment must be confirmed by a second (confirmatory) evaluation meeting the criteria for response and must be performed no less than 4 weeks after the criteria for response are first met.
Outcome measures
| Measure |
Ipilimumab, 10 mg/kg IV, in Corticosteroid-free Patients
n=51 Participants
Participants who had not received corticosteroid therapy for at least 10 days before starting study drug received ipilimumab,10 mg/kg, as a 90-minute intravenous (IV) infusion every 3 weeks (Weeks 1, 4, 7, and 10) during the Induction Phase. Those eligible (patients who did not discontinue due to toxicity, did not show progression at 24 weeks, and who remained clinically stable) for the Maintenance Phase continued to receive ipilimumab, 10 mg/kg IV every 12 weeks, beginning at Week 24.
|
Ipilimumab, 10 mg/kg IV, in Corticosteroid-dependent Patients
n=21 Participants
Participants who required concurrent systemic corticosteroid therapy for adequate control of neurologic signs and symptoms related to metastatic brain lesion received ipilimumab,10 mg/kg, as a 90-minute IV infusion every 3 weeks (Weeks 1, 4, 7, and 10) during the Induction Phase. Those eligible (patients who did not discontinue due to toxicity, did not show progression at 24 weeks, and who remained clinically stable) for the Maintenance Phase continued to receive ipilimumab, 10 mg/kg IV every 12 weeks, beginning at Week 24.
|
|---|---|---|
|
Best Overall Response Rate (BORR) by Modified World Health Organization (mWHO) Criteria and by Immune-relate Response Criteria (irRC)
Global BORR (mWHO criteria)
|
9.8 Percentage of participants
Interval 3.3 to 21.4
|
4.8 Percentage of participants
Interval 0.1 to 23.8
|
|
Best Overall Response Rate (BORR) by Modified World Health Organization (mWHO) Criteria and by Immune-relate Response Criteria (irRC)
BORR in brain (mWHO criteria)
|
15.7 Percentage of participants
Interval 7.0 to 28.6
|
4.8 Percentage of participants
Interval 0.1 to 23.8
|
|
Best Overall Response Rate (BORR) by Modified World Health Organization (mWHO) Criteria and by Immune-relate Response Criteria (irRC)
BORR in non-CNS compartment (mWHO criteria)
|
13.7 Percentage of participants
Interval 5.7 to 26.3
|
4.8 Percentage of participants
Interval 0.1 to 23.8
|
|
Best Overall Response Rate (BORR) by Modified World Health Organization (mWHO) Criteria and by Immune-relate Response Criteria (irRC)
Global BORR (irRC)
|
9.8 Percentage of participants
Interval 3.3 to 21.4
|
4.8 Percentage of participants
Interval 0.1 to 23.8
|
|
Best Overall Response Rate (BORR) by Modified World Health Organization (mWHO) Criteria and by Immune-relate Response Criteria (irRC)
BORR in brain (irRC)
|
15.7 Percentage of participants
Interval 7.0 to 28.6
|
4.8 Percentage of participants
Interval 0.1 to 23.8
|
|
Best Overall Response Rate (BORR) by Modified World Health Organization (mWHO) Criteria and by Immune-relate Response Criteria (irRC)
BORR in non-CNS compartment (irRC criteria )
|
13.7 Percentage of participants
Interval 5.7 to 26.3
|
4.8 Percentage of participants
Interval 0.1 to 23.8
|
SECONDARY outcome
Timeframe: From Day 1, first dose to last tumor assessment up to 18.2 monthsPopulation: All participants who received at least 1 dose of ipilimumab
DOR is defined in patients whose global best overall response is complete (CR) or partial response (PR) as the time between the date of response of confirmed CR or PR, whichever occurs first, and the date of progressive disease or death, whichever occurs first. For patients who remain alive and have not progressed following response, duration of response will be censored on the date of last evaluable tumor assessment.
Outcome measures
| Measure |
Ipilimumab, 10 mg/kg IV, in Corticosteroid-free Patients
n=51 Participants
Participants who had not received corticosteroid therapy for at least 10 days before starting study drug received ipilimumab,10 mg/kg, as a 90-minute intravenous (IV) infusion every 3 weeks (Weeks 1, 4, 7, and 10) during the Induction Phase. Those eligible (patients who did not discontinue due to toxicity, did not show progression at 24 weeks, and who remained clinically stable) for the Maintenance Phase continued to receive ipilimumab, 10 mg/kg IV every 12 weeks, beginning at Week 24.
|
Ipilimumab, 10 mg/kg IV, in Corticosteroid-dependent Patients
n=21 Participants
Participants who required concurrent systemic corticosteroid therapy for adequate control of neurologic signs and symptoms related to metastatic brain lesion received ipilimumab,10 mg/kg, as a 90-minute IV infusion every 3 weeks (Weeks 1, 4, 7, and 10) during the Induction Phase. Those eligible (patients who did not discontinue due to toxicity, did not show progression at 24 weeks, and who remained clinically stable) for the Maintenance Phase continued to receive ipilimumab, 10 mg/kg IV every 12 weeks, beginning at Week 24.
|
|---|---|---|
|
Duration of Response (DOR) by Modified World Health Organization (mWHO) Criteria and by Immune-related Response Criteria (irRC)
DOR by mWHO criteria
|
10.4 Months
Interval 2.9 to 18.2
|
NA Months
The only corticosteroid-dependent patient with response has not progressed or died
|
|
Duration of Response (DOR) by Modified World Health Organization (mWHO) Criteria and by Immune-related Response Criteria (irRC)
DOR by irRC
|
10.4 Months
Interval 2.9 to 18.2
|
NA Months
The only corticosteroid-dependent patient with response has not progressed or died
|
SECONDARY outcome
Timeframe: From Day 1, first dose to the date of progression or death, whichever occurred first up to 22 monthsPopulation: All participants who received at least 1 dose of ipilimumab
PFS is defined as the time between the date of the first dose of study therapy and the date of progression or death, whichever occurs first. A patient who dies without reported prior progression will be considered to have progressed on the date of death. For those who remain alive and have not progressed, PFS will be censored on the date of last evaluable tumor assessment. Participants who have not died and have no recorded postbaseline tumor assessment will be censored on the date of first dose of study therapy. Those who die without any recorded postbaseline tumor assessment will be considered to have progressed on the date of death.
Outcome measures
| Measure |
Ipilimumab, 10 mg/kg IV, in Corticosteroid-free Patients
n=51 Participants
Participants who had not received corticosteroid therapy for at least 10 days before starting study drug received ipilimumab,10 mg/kg, as a 90-minute intravenous (IV) infusion every 3 weeks (Weeks 1, 4, 7, and 10) during the Induction Phase. Those eligible (patients who did not discontinue due to toxicity, did not show progression at 24 weeks, and who remained clinically stable) for the Maintenance Phase continued to receive ipilimumab, 10 mg/kg IV every 12 weeks, beginning at Week 24.
|
Ipilimumab, 10 mg/kg IV, in Corticosteroid-dependent Patients
n=21 Participants
Participants who required concurrent systemic corticosteroid therapy for adequate control of neurologic signs and symptoms related to metastatic brain lesion received ipilimumab,10 mg/kg, as a 90-minute IV infusion every 3 weeks (Weeks 1, 4, 7, and 10) during the Induction Phase. Those eligible (patients who did not discontinue due to toxicity, did not show progression at 24 weeks, and who remained clinically stable) for the Maintenance Phase continued to receive ipilimumab, 10 mg/kg IV every 12 weeks, beginning at Week 24.
|
|---|---|---|
|
Progression-free Survival (PFS) by Modified World Health Organization (mWHO) Criteria and by Immune-related Response Criteria (irRC)
Global PFS (mWHO criteria)
|
1.4 Months
Interval 1.2 to 2.6
|
1.2 Months
Interval 1.2 to 1.3
|
|
Progression-free Survival (PFS) by Modified World Health Organization (mWHO) Criteria and by Immune-related Response Criteria (irRC)
PFS in brain (mWHO criteria)
|
1.5 Months
Interval 1.2 to 2.6
|
1.2 Months
Interval 1.2 to 1.3
|
|
Progression-free Survival (PFS) by Modified World Health Organization (mWHO) Criteria and by Immune-related Response Criteria (irRC)
PFS in non-CNS compartment (mWHO criteria)
|
2.6 Months
Interval 1.3 to 4.1
|
1.3 Months
Interval 1.2 to 2.5
|
|
Progression-free Survival (PFS) by Modified World Health Organization (mWHO) Criteria and by Immune-related Response Criteria (irRC)
Global PFS (irRC)
|
2.7 Months
Interval 1.6 to 3.7
|
1.3 Months
Interval 1.2 to 2.5
|
|
Progression-free Survival (PFS) by Modified World Health Organization (mWHO) Criteria and by Immune-related Response Criteria (irRC)
PFS in brain (irRC)
|
1.9 Months
Interval 1.2 to 2.9
|
1.2 Months
Interval 1.2 to 1.3
|
|
Progression-free Survival (PFS) by Modified World Health Organization (mWHO) Criteria and by Immune-related Response Criteria (irRC)
PFS in non-CNS compartment (irRC)
|
3.3 Months
Interval 2.6 to 4.7
|
1.3 Months
Interval 1.2 to 2.5
|
SECONDARY outcome
Timeframe: From first dose to Months 6, 12, 18, 24, and 36 monthsPopulation: All participants who received at least 1 dose of ipilimumab
OS is defined as the time from the first dose of study drug until the date of death. Overall survival rate is the percentage of participants known to be alive at a timepoint. For those patients who did not die, OS was censored at the recorded last date of patient contact, and those with a missing recorded last date of contact will be censored at the last date the patient was known to be alive. The survival rate at a specified time-point is the probability that a patient is alive at that time following randomization. The rate is calculated for each treatment group using the Kaplan-Meier product-limit method. A corresponding 2-sided 95% bootstrap confidence interval will be calculated.
Outcome measures
| Measure |
Ipilimumab, 10 mg/kg IV, in Corticosteroid-free Patients
n=51 Participants
Participants who had not received corticosteroid therapy for at least 10 days before starting study drug received ipilimumab,10 mg/kg, as a 90-minute intravenous (IV) infusion every 3 weeks (Weeks 1, 4, 7, and 10) during the Induction Phase. Those eligible (patients who did not discontinue due to toxicity, did not show progression at 24 weeks, and who remained clinically stable) for the Maintenance Phase continued to receive ipilimumab, 10 mg/kg IV every 12 weeks, beginning at Week 24.
|
Ipilimumab, 10 mg/kg IV, in Corticosteroid-dependent Patients
n=21 Participants
Participants who required concurrent systemic corticosteroid therapy for adequate control of neurologic signs and symptoms related to metastatic brain lesion received ipilimumab,10 mg/kg, as a 90-minute IV infusion every 3 weeks (Weeks 1, 4, 7, and 10) during the Induction Phase. Those eligible (patients who did not discontinue due to toxicity, did not show progression at 24 weeks, and who remained clinically stable) for the Maintenance Phase continued to receive ipilimumab, 10 mg/kg IV every 12 weeks, beginning at Week 24.
|
|---|---|---|
|
Number of Participants Surviving at 6, 12, 18, 24, and 36 Months (Overall Survival [OS] Rate)
At 6 months
|
0.55 Probability of being alive
Interval 0.41 to 0.68
|
0.38 Probability of being alive
Interval 0.17 to 0.59
|
|
Number of Participants Surviving at 6, 12, 18, 24, and 36 Months (Overall Survival [OS] Rate)
At 12 months
|
0.31 Probability of being alive
Interval 0.18 to 0.44
|
0.19 Probability of being alive
Interval 0.02 to 0.36
|
|
Number of Participants Surviving at 6, 12, 18, 24, and 36 Months (Overall Survival [OS] Rate)
At 18 months
|
0.26 Probability of being alive
Interval 0.14 to 0.39
|
0.19 Probability of being alive
Interval 0.02 to 0.36
|
|
Number of Participants Surviving at 6, 12, 18, 24, and 36 Months (Overall Survival [OS] Rate)
At 24 months
|
0.26 Probability of being alive
Interval 0.14 to 0.39
|
0.10 Probability of being alive
Interval 0.0 to 0.22
|
|
Number of Participants Surviving at 6, 12, 18, 24, and 36 Months (Overall Survival [OS] Rate)
At 36 months
|
0.26 Probability of being alive
Interval 0.14 to 0.39
|
0.10 Probability of being alive
Interval 0.0 to 0.22
|
SECONDARY outcome
Timeframe: Continuously from Day 1, first dose, to 70 days following last dose of ipilimumabPopulation: All participants who received at least 1 dose of ipilimumab
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. Treatment-related=having certain, probable, possible, or missing relationship to study drug. Grade (Gr) 1=Mild, Gr 2=Moderate, Gr 3=Severe, Gr 4=Life-threatening or disabling, Gr 5=Death.
Outcome measures
| Measure |
Ipilimumab, 10 mg/kg IV, in Corticosteroid-free Patients
n=51 Participants
Participants who had not received corticosteroid therapy for at least 10 days before starting study drug received ipilimumab,10 mg/kg, as a 90-minute intravenous (IV) infusion every 3 weeks (Weeks 1, 4, 7, and 10) during the Induction Phase. Those eligible (patients who did not discontinue due to toxicity, did not show progression at 24 weeks, and who remained clinically stable) for the Maintenance Phase continued to receive ipilimumab, 10 mg/kg IV every 12 weeks, beginning at Week 24.
|
Ipilimumab, 10 mg/kg IV, in Corticosteroid-dependent Patients
n=21 Participants
Participants who required concurrent systemic corticosteroid therapy for adequate control of neurologic signs and symptoms related to metastatic brain lesion received ipilimumab,10 mg/kg, as a 90-minute IV infusion every 3 weeks (Weeks 1, 4, 7, and 10) during the Induction Phase. Those eligible (patients who did not discontinue due to toxicity, did not show progression at 24 weeks, and who remained clinically stable) for the Maintenance Phase continued to receive ipilimumab, 10 mg/kg IV every 12 weeks, beginning at Week 24.
|
|---|---|---|
|
Number of Participants Who Died or Had a Treatment-related Adverse Event (AE), Immune-related AE, Immune-related Serious Adverse Event (SAE), Nervous System Disorder, Treatment-related Nervous System Disorder, SAE, and AE Leading to Discontinuation
Immune-related SAES (Fatal)
|
0 Participants
|
0 Participants
|
|
Number of Participants Who Died or Had a Treatment-related Adverse Event (AE), Immune-related AE, Immune-related Serious Adverse Event (SAE), Nervous System Disorder, Treatment-related Nervous System Disorder, SAE, and AE Leading to Discontinuation
Nervous system disorder (NSD) (All)
|
40 Participants
|
14 Participants
|
|
Number of Participants Who Died or Had a Treatment-related Adverse Event (AE), Immune-related AE, Immune-related Serious Adverse Event (SAE), Nervous System Disorder, Treatment-related Nervous System Disorder, SAE, and AE Leading to Discontinuation
NSD (Grade 3/4)
|
17 Participants
|
7 Participants
|
|
Number of Participants Who Died or Had a Treatment-related Adverse Event (AE), Immune-related AE, Immune-related Serious Adverse Event (SAE), Nervous System Disorder, Treatment-related Nervous System Disorder, SAE, and AE Leading to Discontinuation
NSD (Fatal)
|
0 Participants
|
1 Participants
|
|
Number of Participants Who Died or Had a Treatment-related Adverse Event (AE), Immune-related AE, Immune-related Serious Adverse Event (SAE), Nervous System Disorder, Treatment-related Nervous System Disorder, SAE, and AE Leading to Discontinuation
Treatment-related NSD (All)
|
8 Participants
|
3 Participants
|
|
Number of Participants Who Died or Had a Treatment-related Adverse Event (AE), Immune-related AE, Immune-related Serious Adverse Event (SAE), Nervous System Disorder, Treatment-related Nervous System Disorder, SAE, and AE Leading to Discontinuation
Treatment-related NSD (Gr 3/4)
|
1 Participants
|
0 Participants
|
|
Number of Participants Who Died or Had a Treatment-related Adverse Event (AE), Immune-related AE, Immune-related Serious Adverse Event (SAE), Nervous System Disorder, Treatment-related Nervous System Disorder, SAE, and AE Leading to Discontinuation
Treatment-related NSD (Fatal)
|
0 Participants
|
0 Participants
|
|
Number of Participants Who Died or Had a Treatment-related Adverse Event (AE), Immune-related AE, Immune-related Serious Adverse Event (SAE), Nervous System Disorder, Treatment-related Nervous System Disorder, SAE, and AE Leading to Discontinuation
SAE (All)
|
36 Participants
|
17 Participants
|
|
Number of Participants Who Died or Had a Treatment-related Adverse Event (AE), Immune-related AE, Immune-related Serious Adverse Event (SAE), Nervous System Disorder, Treatment-related Nervous System Disorder, SAE, and AE Leading to Discontinuation
SAE (Grade 3/4)
|
18 Participants
|
7 Participants
|
|
Number of Participants Who Died or Had a Treatment-related Adverse Event (AE), Immune-related AE, Immune-related Serious Adverse Event (SAE), Nervous System Disorder, Treatment-related Nervous System Disorder, SAE, and AE Leading to Discontinuation
SAE (Fatal)
|
17 Participants
|
10 Participants
|
|
Number of Participants Who Died or Had a Treatment-related Adverse Event (AE), Immune-related AE, Immune-related Serious Adverse Event (SAE), Nervous System Disorder, Treatment-related Nervous System Disorder, SAE, and AE Leading to Discontinuation
AEs leading to discontinuation (All)
|
15 Participants
|
9 Participants
|
|
Number of Participants Who Died or Had a Treatment-related Adverse Event (AE), Immune-related AE, Immune-related Serious Adverse Event (SAE), Nervous System Disorder, Treatment-related Nervous System Disorder, SAE, and AE Leading to Discontinuation
AEs leading to discontinuation (Grade 3/4)
|
9 Participants
|
4 Participants
|
|
Number of Participants Who Died or Had a Treatment-related Adverse Event (AE), Immune-related AE, Immune-related Serious Adverse Event (SAE), Nervous System Disorder, Treatment-related Nervous System Disorder, SAE, and AE Leading to Discontinuation
AEs leading to discontinuation (Fatal)
|
5 Participants
|
4 Participants
|
|
Number of Participants Who Died or Had a Treatment-related Adverse Event (AE), Immune-related AE, Immune-related Serious Adverse Event (SAE), Nervous System Disorder, Treatment-related Nervous System Disorder, SAE, and AE Leading to Discontinuation
Deaths
|
37 Participants
|
20 Participants
|
|
Number of Participants Who Died or Had a Treatment-related Adverse Event (AE), Immune-related AE, Immune-related Serious Adverse Event (SAE), Nervous System Disorder, Treatment-related Nervous System Disorder, SAE, and AE Leading to Discontinuation
Treatment-related AEs (all)
|
45 Participants
|
17 Participants
|
|
Number of Participants Who Died or Had a Treatment-related Adverse Event (AE), Immune-related AE, Immune-related Serious Adverse Event (SAE), Nervous System Disorder, Treatment-related Nervous System Disorder, SAE, and AE Leading to Discontinuation
Treatment-related AEs (Grade 3/4)
|
17 Participants
|
4 Participants
|
|
Number of Participants Who Died or Had a Treatment-related Adverse Event (AE), Immune-related AE, Immune-related Serious Adverse Event (SAE), Nervous System Disorder, Treatment-related Nervous System Disorder, SAE, and AE Leading to Discontinuation
Treatment-related AEs (Fatal)
|
0 Participants
|
0 Participants
|
|
Number of Participants Who Died or Had a Treatment-related Adverse Event (AE), Immune-related AE, Immune-related Serious Adverse Event (SAE), Nervous System Disorder, Treatment-related Nervous System Disorder, SAE, and AE Leading to Discontinuation
Immune-related AEs (All)
|
35 Participants
|
13 Participants
|
|
Number of Participants Who Died or Had a Treatment-related Adverse Event (AE), Immune-related AE, Immune-related Serious Adverse Event (SAE), Nervous System Disorder, Treatment-related Nervous System Disorder, SAE, and AE Leading to Discontinuation
Immune-related AEs (Grade 3/4)
|
11 Participants
|
3 Participants
|
|
Number of Participants Who Died or Had a Treatment-related Adverse Event (AE), Immune-related AE, Immune-related Serious Adverse Event (SAE), Nervous System Disorder, Treatment-related Nervous System Disorder, SAE, and AE Leading to Discontinuation
Immune-related AEs (Fatal)
|
0 Participants
|
0 Participants
|
|
Number of Participants Who Died or Had a Treatment-related Adverse Event (AE), Immune-related AE, Immune-related Serious Adverse Event (SAE), Nervous System Disorder, Treatment-related Nervous System Disorder, SAE, and AE Leading to Discontinuation
Immune-related SAEs (All)
|
11 Participants
|
6 Participants
|
|
Number of Participants Who Died or Had a Treatment-related Adverse Event (AE), Immune-related AE, Immune-related Serious Adverse Event (SAE), Nervous System Disorder, Treatment-related Nervous System Disorder, SAE, and AE Leading to Discontinuation
Immune-related SAES (Grade 3/4)
|
7 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: From Day 1, first dose to a maximum of 4.2 monthsPopulation: All participants who received at least 1 dose of ipilimumab. n=number of participants with a best overall response of CR or PR.
Onset of response is defined as the time between the first dose of study therapy and the date when measurement criteria are first met for global best overall response of partial (PR) or complete (CR), whichever occurs first. CR=complete disappearance of all index lesions. PR=decrease, relative to baseline, of 50% or greater in the sum of the 2 largest perpendicular diameters of all index lesions.
Outcome measures
| Measure |
Ipilimumab, 10 mg/kg IV, in Corticosteroid-free Patients
n=51 Participants
Participants who had not received corticosteroid therapy for at least 10 days before starting study drug received ipilimumab,10 mg/kg, as a 90-minute intravenous (IV) infusion every 3 weeks (Weeks 1, 4, 7, and 10) during the Induction Phase. Those eligible (patients who did not discontinue due to toxicity, did not show progression at 24 weeks, and who remained clinically stable) for the Maintenance Phase continued to receive ipilimumab, 10 mg/kg IV every 12 weeks, beginning at Week 24.
|
Ipilimumab, 10 mg/kg IV, in Corticosteroid-dependent Patients
n=21 Participants
Participants who required concurrent systemic corticosteroid therapy for adequate control of neurologic signs and symptoms related to metastatic brain lesion received ipilimumab,10 mg/kg, as a 90-minute IV infusion every 3 weeks (Weeks 1, 4, 7, and 10) during the Induction Phase. Those eligible (patients who did not discontinue due to toxicity, did not show progression at 24 weeks, and who remained clinically stable) for the Maintenance Phase continued to receive ipilimumab, 10 mg/kg IV every 12 weeks, beginning at Week 24.
|
|---|---|---|
|
Onset of Response by Modified World Health Organization (mWHO) Criteria and Immune-related Response Criteria (irRC)
Onset of response (mWHO criteria) (n=5, 1)
|
1.2 Months
Interval 1.1 to 4.2
|
1.2 Months
Interval 1.2 to 1.2
|
|
Onset of Response by Modified World Health Organization (mWHO) Criteria and Immune-related Response Criteria (irRC)
Onset of response (irRC) (n=5, 1)
|
1.2 Months
Interval 1.1 to 4.2
|
1.2 Months
Interval 1.2 to 1.2
|
SECONDARY outcome
Timeframe: From first dose to 24 monthsPopulation: All participants who received at least 1 dose of ipilimumab
OS is defined as the time from date of first dose of study drug until the date of death. For those patients who did not die, OS was censored at the recorded last date of patient contact, and those missing a recorded last date of contact will be censored at the last date the patient was known to be alive.
Outcome measures
| Measure |
Ipilimumab, 10 mg/kg IV, in Corticosteroid-free Patients
n=51 Participants
Participants who had not received corticosteroid therapy for at least 10 days before starting study drug received ipilimumab,10 mg/kg, as a 90-minute intravenous (IV) infusion every 3 weeks (Weeks 1, 4, 7, and 10) during the Induction Phase. Those eligible (patients who did not discontinue due to toxicity, did not show progression at 24 weeks, and who remained clinically stable) for the Maintenance Phase continued to receive ipilimumab, 10 mg/kg IV every 12 weeks, beginning at Week 24.
|
Ipilimumab, 10 mg/kg IV, in Corticosteroid-dependent Patients
n=21 Participants
Participants who required concurrent systemic corticosteroid therapy for adequate control of neurologic signs and symptoms related to metastatic brain lesion received ipilimumab,10 mg/kg, as a 90-minute IV infusion every 3 weeks (Weeks 1, 4, 7, and 10) during the Induction Phase. Those eligible (patients who did not discontinue due to toxicity, did not show progression at 24 weeks, and who remained clinically stable) for the Maintenance Phase continued to receive ipilimumab, 10 mg/kg IV every 12 weeks, beginning at Week 24.
|
|---|---|---|
|
Overall Survival (OS)
|
6.97 Months
Interval 4.14 to 10.81
|
3.75 Months
Interval 1.64 to 7.33
|
Adverse Events
Ipilimumab, 10 mg/kg IV, in Corticosteroid-dependent Patients
Serious events: 17 serious events
Other events: 20 other events
Deaths: 0 deaths
Ipilimumab, 10 mg/kg IV, in Corticosteroid-free Patients
Serious events: 36 serious events
Other events: 48 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Ipilimumab, 10 mg/kg IV, in Corticosteroid-dependent Patients
n=21 participants at risk
Participants who required concurrent systemic corticosteroid therapy for adequate control of neurologic signs and symptoms related to metastatic brain lesion received ipilimumab,10 mg/kg, as a 90-minute IV infusion every 3 weeks (Weeks 1, 4, 7, and 10) during the Induction Phase. Those eligible (patients who did not discontinue due to toxicity, did not show progression at 24 weeks, and who remained clinically stable) for the Maintenance Phase continued to receive ipilimumab, 10 mg/kg IV every 12 weeks, beginning at Week 24.
|
Ipilimumab, 10 mg/kg IV, in Corticosteroid-free Patients
n=51 participants at risk
Participants who had not received corticosteroid therapy for at least 10 days before starting study drug received ipilimumab,10 mg/kg, as a 90-minute intravenous (IV) infusion every 3 weeks (Weeks 1, 4, 7, and 10) during the Induction Phase. Those eligible (patients who did not discontinue due to toxicity, did not show progression at 24 weeks, and who remained clinically stable) for the Maintenance Phase continued to receive ipilimumab, 10 mg/kg IV every 12 weeks, beginning at Week 24.
|
|---|---|---|
|
Nervous system disorders
Ataxia
|
4.8%
1/21
|
0.00%
0/51
|
|
Hepatobiliary disorders
Bile duct stone
|
0.00%
0/21
|
2.0%
1/51
|
|
Nervous system disorders
Cerebral haemorrhage
|
4.8%
1/21
|
5.9%
3/51
|
|
General disorders
Fatigue
|
4.8%
1/21
|
3.9%
2/51
|
|
General disorders
Pyrexia
|
0.00%
0/21
|
5.9%
3/51
|
|
Skin and subcutaneous tissue disorders
Rash
|
4.8%
1/21
|
0.00%
0/51
|
|
Nervous system disorders
Syncope
|
4.8%
1/21
|
0.00%
0/51
|
|
Cardiac disorders
Bradycardia
|
0.00%
0/21
|
2.0%
1/51
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/21
|
2.0%
1/51
|
|
Nervous system disorders
Hemiparesis
|
9.5%
2/21
|
0.00%
0/51
|
|
Immune system disorders
Hypersensitivity
|
4.8%
1/21
|
0.00%
0/51
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
4.8%
1/21
|
0.00%
0/51
|
|
Gastrointestinal disorders
Intestinal ischaemia
|
0.00%
0/21
|
2.0%
1/51
|
|
Investigations
Lipase increased
|
0.00%
0/21
|
2.0%
1/51
|
|
Respiratory, thoracic and mediastinal disorders
Lung infiltration
|
0.00%
0/21
|
2.0%
1/51
|
|
Nervous system disorders
Mental impairment
|
4.8%
1/21
|
0.00%
0/51
|
|
Infections and infestations
Pneumonia
|
0.00%
0/21
|
5.9%
3/51
|
|
Infections and infestations
Pneumonia viral
|
0.00%
0/21
|
2.0%
1/51
|
|
Infections and infestations
Sepsis
|
4.8%
1/21
|
2.0%
1/51
|
|
Nervous system disorders
Somnolence
|
0.00%
0/21
|
5.9%
3/51
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/21
|
2.0%
1/51
|
|
Eye disorders
Conjunctivitis
|
0.00%
0/21
|
3.9%
2/51
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/21
|
2.0%
1/51
|
|
General disorders
Disease progression
|
47.6%
10/21
|
31.4%
16/51
|
|
Injury, poisoning and procedural complications
Fracture
|
4.8%
1/21
|
0.00%
0/51
|
|
Nervous system disorders
Lethargy
|
0.00%
0/21
|
2.0%
1/51
|
|
Nervous system disorders
Loss of consciousness
|
0.00%
0/21
|
2.0%
1/51
|
|
Infections and infestations
Metapneumovirus infection
|
0.00%
0/21
|
2.0%
1/51
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/21
|
2.0%
1/51
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/21
|
2.0%
1/51
|
|
Metabolism and nutrition disorders
Dehydration
|
9.5%
2/21
|
9.8%
5/51
|
|
Gastrointestinal disorders
Diarrhoea
|
9.5%
2/21
|
11.8%
6/51
|
|
Nervous system disorders
Headache
|
0.00%
0/21
|
3.9%
2/51
|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/21
|
2.0%
1/51
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour pain
|
0.00%
0/21
|
2.0%
1/51
|
|
Endocrine disorders
Adrenal insufficiency
|
4.8%
1/21
|
3.9%
2/51
|
|
Nervous system disorders
Aphasia
|
4.8%
1/21
|
0.00%
0/51
|
|
Investigations
Aspartate aminotransferase increased
|
4.8%
1/21
|
0.00%
0/51
|
|
Infections and infestations
Colon gangrene
|
0.00%
0/21
|
2.0%
1/51
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
0.00%
0/21
|
2.0%
1/51
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
0.00%
0/21
|
2.0%
1/51
|
|
Eye disorders
Retinal detachment
|
0.00%
0/21
|
2.0%
1/51
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/21
|
3.9%
2/51
|
|
Psychiatric disorders
Confusional state
|
9.5%
2/21
|
9.8%
5/51
|
|
Nervous system disorders
Depressed level of consciousness
|
9.5%
2/21
|
3.9%
2/51
|
|
Gastrointestinal disorders
Haematochezia
|
4.8%
1/21
|
0.00%
0/51
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/21
|
2.0%
1/51
|
|
Vascular disorders
Hypotension
|
4.8%
1/21
|
0.00%
0/51
|
|
Infections and infestations
Septic shock
|
0.00%
0/21
|
2.0%
1/51
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.00%
0/21
|
2.0%
1/51
|
|
Nervous system disorders
Speech disorder
|
0.00%
0/21
|
2.0%
1/51
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/21
|
2.0%
1/51
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/21
|
9.8%
5/51
|
|
Investigations
Alanine aminotransferase increased
|
4.8%
1/21
|
2.0%
1/51
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
4.8%
1/21
|
0.00%
0/51
|
|
Infections and infestations
Bacteraemia
|
4.8%
1/21
|
0.00%
0/51
|
|
Gastrointestinal disorders
Colitis
|
14.3%
3/21
|
9.8%
5/51
|
|
Nervous system disorders
Haemorrhage intracranial
|
4.8%
1/21
|
0.00%
0/51
|
|
Endocrine disorders
Hypophysitis
|
0.00%
0/21
|
2.0%
1/51
|
|
Psychiatric disorders
Mental status changes
|
0.00%
0/21
|
3.9%
2/51
|
|
Renal and urinary disorders
Renal failure acute
|
0.00%
0/21
|
2.0%
1/51
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/21
|
2.0%
1/51
|
|
Injury, poisoning and procedural complications
Brain herniation
|
0.00%
0/21
|
2.0%
1/51
|
|
Nervous system disorders
Convulsion
|
14.3%
3/21
|
5.9%
3/51
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic malignant melanoma
|
0.00%
0/21
|
2.0%
1/51
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
4.8%
1/21
|
2.0%
1/51
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/21
|
9.8%
5/51
|
|
General disorders
Pain
|
0.00%
0/21
|
2.0%
1/51
|
|
Nervous system disorders
Peripheral motor neuropathy
|
4.8%
1/21
|
0.00%
0/51
|
|
Gastrointestinal disorders
Peritoneal haemorrhage
|
4.8%
1/21
|
0.00%
0/51
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/21
|
3.9%
2/51
|
|
Renal and urinary disorders
Renal failure
|
4.8%
1/21
|
0.00%
0/51
|
Other adverse events
| Measure |
Ipilimumab, 10 mg/kg IV, in Corticosteroid-dependent Patients
n=21 participants at risk
Participants who required concurrent systemic corticosteroid therapy for adequate control of neurologic signs and symptoms related to metastatic brain lesion received ipilimumab,10 mg/kg, as a 90-minute IV infusion every 3 weeks (Weeks 1, 4, 7, and 10) during the Induction Phase. Those eligible (patients who did not discontinue due to toxicity, did not show progression at 24 weeks, and who remained clinically stable) for the Maintenance Phase continued to receive ipilimumab, 10 mg/kg IV every 12 weeks, beginning at Week 24.
|
Ipilimumab, 10 mg/kg IV, in Corticosteroid-free Patients
n=51 participants at risk
Participants who had not received corticosteroid therapy for at least 10 days before starting study drug received ipilimumab,10 mg/kg, as a 90-minute intravenous (IV) infusion every 3 weeks (Weeks 1, 4, 7, and 10) during the Induction Phase. Those eligible (patients who did not discontinue due to toxicity, did not show progression at 24 weeks, and who remained clinically stable) for the Maintenance Phase continued to receive ipilimumab, 10 mg/kg IV every 12 weeks, beginning at Week 24.
|
|---|---|---|
|
General disorders
Fatigue
|
52.4%
11/21
|
52.9%
27/51
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
4.8%
1/21
|
5.9%
3/51
|
|
General disorders
Pyrexia
|
9.5%
2/21
|
7.8%
4/51
|
|
Skin and subcutaneous tissue disorders
Rash
|
33.3%
7/21
|
39.2%
20/51
|
|
Nervous system disorders
Dizziness
|
9.5%
2/21
|
21.6%
11/51
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/21
|
5.9%
3/51
|
|
Investigations
Haemoglobin decreased
|
9.5%
2/21
|
3.9%
2/51
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
4.8%
1/21
|
5.9%
3/51
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
14.3%
3/21
|
2.0%
1/51
|
|
General disorders
Influenza like illness
|
0.00%
0/21
|
9.8%
5/51
|
|
Gastrointestinal disorders
Stomatitis
|
9.5%
2/21
|
0.00%
0/51
|
|
Eye disorders
Visual impairment
|
9.5%
2/21
|
2.0%
1/51
|
|
Metabolism and nutrition disorders
Decreased appetite
|
23.8%
5/21
|
27.5%
14/51
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/21
|
7.8%
4/51
|
|
Gastrointestinal disorders
Dyspepsia
|
9.5%
2/21
|
11.8%
6/51
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/21
|
5.9%
3/51
|
|
Psychiatric disorders
Insomnia
|
19.0%
4/21
|
15.7%
8/51
|
|
Nervous system disorders
Paraesthesia
|
14.3%
3/21
|
2.0%
1/51
|
|
General disorders
Thirst
|
9.5%
2/21
|
0.00%
0/51
|
|
Psychiatric disorders
Agitation
|
4.8%
1/21
|
5.9%
3/51
|
|
Nervous system disorders
Brain oedema
|
0.00%
0/21
|
7.8%
4/51
|
|
Gastrointestinal disorders
Constipation
|
23.8%
5/21
|
17.6%
9/51
|
|
Metabolism and nutrition disorders
Dehydration
|
9.5%
2/21
|
2.0%
1/51
|
|
Gastrointestinal disorders
Diarrhoea
|
42.9%
9/21
|
47.1%
24/51
|
|
Nervous system disorders
Headache
|
28.6%
6/21
|
39.2%
20/51
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
4.8%
1/21
|
5.9%
3/51
|
|
Nervous system disorders
Memory impairment
|
0.00%
0/21
|
9.8%
5/51
|
|
General disorders
Oedema peripheral
|
28.6%
6/21
|
7.8%
4/51
|
|
Cardiac disorders
Sinus tachycardia
|
9.5%
2/21
|
0.00%
0/51
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour pain
|
9.5%
2/21
|
0.00%
0/51
|
|
Investigations
Weight decreased
|
4.8%
1/21
|
13.7%
7/51
|
|
Endocrine disorders
Adrenal insufficiency
|
9.5%
2/21
|
2.0%
1/51
|
|
Nervous system disorders
Aphasia
|
4.8%
1/21
|
5.9%
3/51
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
9.5%
2/21
|
5.9%
3/51
|
|
Investigations
Aspartate aminotransferase increased
|
14.3%
3/21
|
7.8%
4/51
|
|
Investigations
Blood alkaline phosphatase increased
|
9.5%
2/21
|
7.8%
4/51
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
9.5%
2/21
|
21.6%
11/51
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
9.5%
2/21
|
9.8%
5/51
|
|
General disorders
Gait disturbance
|
14.3%
3/21
|
2.0%
1/51
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
4.8%
1/21
|
5.9%
3/51
|
|
Renal and urinary disorders
Polyuria
|
9.5%
2/21
|
0.00%
0/51
|
|
Gastrointestinal disorders
Abdominal pain
|
14.3%
3/21
|
7.8%
4/51
|
|
Psychiatric disorders
Confusional state
|
4.8%
1/21
|
7.8%
4/51
|
|
Injury, poisoning and procedural complications
Contusion
|
14.3%
3/21
|
3.9%
2/51
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
19.0%
4/21
|
7.8%
4/51
|
|
Vascular disorders
Hypertension
|
0.00%
0/21
|
7.8%
4/51
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/21
|
7.8%
4/51
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
14.3%
3/21
|
9.8%
5/51
|
|
Gastrointestinal disorders
Vomiting
|
4.8%
1/21
|
19.6%
10/51
|
|
Investigations
Alanine aminotransferase increased
|
14.3%
3/21
|
9.8%
5/51
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
19.0%
4/21
|
15.7%
8/51
|
|
Infections and infestations
Bronchitis
|
0.00%
0/21
|
5.9%
3/51
|
|
General disorders
Chills
|
0.00%
0/21
|
9.8%
5/51
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/21
|
5.9%
3/51
|
|
Infections and infestations
Sinusitis
|
0.00%
0/21
|
11.8%
6/51
|
|
Eye disorders
Vision blurred
|
9.5%
2/21
|
13.7%
7/51
|
|
Nervous system disorders
Convulsion
|
4.8%
1/21
|
9.8%
5/51
|
|
Gastrointestinal disorders
Flatulence
|
9.5%
2/21
|
7.8%
4/51
|
|
Nervous system disorders
Hypoaesthesia
|
4.8%
1/21
|
7.8%
4/51
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
14.3%
3/21
|
7.8%
4/51
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
9.5%
2/21
|
5.9%
3/51
|
|
Gastrointestinal disorders
Nausea
|
19.0%
4/21
|
37.3%
19/51
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
28.6%
6/21
|
33.3%
17/51
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Bristol-Myers Squibb Co. agreements with investigators vary; constant is our right to embargo communications regarding trial results prior to public release for a period ≤60 days from submittal for review. We will not prohibit investigators from publishing, but will prohibit the disclosure of previously undisclosed confidential information other than study results, and request postponement of single-center publications until after disclosure of the clinical trial's primary publication.
- Publication restrictions are in place
Restriction type: OTHER