Trial Outcomes & Findings for Phase 2 Study of Ipilimumab in Japanese Advanced Melanoma Patients (NCT NCT01990859)
NCT ID: NCT01990859
Last Updated: 2016-03-14
Results Overview
AEs graded using National Cancer Institute 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 AEs (irAEs) characterized by potential association with inflammation and considered by investigator as drug related. Primary endpoint (PE) includes results from Day 1 to 12 weeks after initial dose of last participant. Data evaluated at PE last patient, last visit (LPLV).
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
20 participants
Primary outcome timeframe
Day 1 to 90 Days after the last dose, up to May 2014
Results posted on
2016-03-14
Participant Flow
Study initiated 12 December 2013 and completed February 2015. Previously treated or untreated patients with Stage III (unresectable) or Stage IV melanoma were recruited. Previously untreated defined as: patients without treatment for metastatic disease but who may have received treatment in the adjuvant setting.
26 participants were enrolled and 20 were treated with study drug. Of the 6 participants not treated: 5 no longer met study criteria, 1 withdrew consent.
Participant milestones
| Measure |
Ipilimumab
During treatment, participants received Ipilimumab intravenous (IV) injection 3 mg/kg every 3 weeks, up to 4 doses (12 weeks). Study was divided into 4 Phases: Screening Phase, Induction Phase, Toxicity/Progressive Disease(PD) Follow Up Phase, and Overall Survival Phase. The Induction Phase consisted of treatment and a 12 week post dosing follow up. It started at first dose and ended at Week 24, or earlier if participant discontinued treatment and moved to Follow-Up Phase.
|
|---|---|
|
Treatment (4 Doses Over 12 Weeks)
STARTED
|
20
|
|
Treatment (4 Doses Over 12 Weeks)
COMPLETED
|
15
|
|
Treatment (4 Doses Over 12 Weeks)
NOT COMPLETED
|
5
|
|
Week 12 to Week 24 Post Dosing Follow Up
STARTED
|
20
|
|
Week 12 to Week 24 Post Dosing Follow Up
COMPLETED
|
3
|
|
Week 12 to Week 24 Post Dosing Follow Up
NOT COMPLETED
|
17
|
|
90 Day Follow Up for All Participants
STARTED
|
20
|
|
90 Day Follow Up for All Participants
COMPLETED
|
20
|
|
90 Day Follow Up for All Participants
NOT COMPLETED
|
0
|
Reasons for withdrawal
| Measure |
Ipilimumab
During treatment, participants received Ipilimumab intravenous (IV) injection 3 mg/kg every 3 weeks, up to 4 doses (12 weeks). Study was divided into 4 Phases: Screening Phase, Induction Phase, Toxicity/Progressive Disease(PD) Follow Up Phase, and Overall Survival Phase. The Induction Phase consisted of treatment and a 12 week post dosing follow up. It started at first dose and ended at Week 24, or earlier if participant discontinued treatment and moved to Follow-Up Phase.
|
|---|---|
|
Treatment (4 Doses Over 12 Weeks)
Progressive Disease
|
5
|
|
Week 12 to Week 24 Post Dosing Follow Up
Disease Progression
|
17
|
Baseline Characteristics
Phase 2 Study of Ipilimumab in Japanese Advanced Melanoma Patients
Baseline characteristics by cohort
| Measure |
Ipilimumab
n=20 Participants
Participants received Ipilimumab intravenous (IV) injection 3 mg/kg every 3 weeks, up to 4 doses.
|
|---|---|
|
Age, Continuous
|
62.5 years
n=5 Participants
|
|
Age, Customized
Less than 65 years
|
13 participants
n=5 Participants
|
|
Age, Customized
Greater than, equal to 65 years
|
7 participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Japanese
|
20 participants
n=5 Participants
|
|
Region of Enrollment
Japan
|
20 participants
n=5 Participants
|
|
M-Stage at Study Entry
M0
|
1 participants
n=5 Participants
|
|
M-Stage at Study Entry
M1A
|
1 participants
n=5 Participants
|
|
M-Stage at Study Entry
M1B
|
4 participants
n=5 Participants
|
|
M-Stage at Study Entry
M1C
|
14 participants
n=5 Participants
|
|
Eastern Cooperative Oncology Group (ECOG) Performance Status (PS)
ECOG PS 0
|
14 participants
n=5 Participants
|
|
Eastern Cooperative Oncology Group (ECOG) Performance Status (PS)
ECOG PS 1
|
6 participants
n=5 Participants
|
|
Height in centimeters (cm)
|
161.7 cm
n=5 Participants
|
|
Weight in kilograms (kg)
|
64.0 kg
n=5 Participants
|
|
Baseline Lactate Dehydrogenase (LDH)
Normal
|
8 participants
n=5 Participants
|
|
Baseline Lactate Dehydrogenase (LDH)
Elevated
|
12 participants
n=5 Participants
|
|
Baseline LDH Greater than 2 Times Upper Limit of Normal
Normal
|
13 participants
n=5 Participants
|
|
Baseline LDH Greater than 2 Times Upper Limit of Normal
Elevated
|
7 participants
n=5 Participants
|
|
Prior Systemic Anti-Cancer Therapy
Yes
|
16 participants
n=5 Participants
|
|
Prior Systemic Anti-Cancer Therapy
No
|
4 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Day 1 to 90 Days after the last dose, up to May 2014Population: All participants in the study who received at least one dose of treatment with ipilimumab were summarized. Data up to May 2014 included.
AEs graded using National Cancer Institute 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 AEs (irAEs) characterized by potential association with inflammation and considered by investigator as drug related. Primary endpoint (PE) includes results from Day 1 to 12 weeks after initial dose of last participant. Data evaluated at PE last patient, last visit (LPLV).
Outcome measures
| Measure |
Ipilimumab
n=20 Participants
During treatment, participants received Ipilimumab intravenous (IV) injection 3 mg/kg every 3 weeks, up to 4 doses (12 weeks). Study was divided into 4 Phases: Screening Phase, Induction Phase, Toxicity/Progressive Disease(PD) Follow Up Phase, and Overall Survival Phase. The Induction Phase consisted of treatment and a 12 week post dosing follow up. It started at first dose and ended at Week 24, or earlier if participant discontinued treatment and moved to Follow-Up Phase.
|
|---|---|
|
Number of Participants With Death, Serious Adverse Events (SAEs), Adverse Events (AEs) Leading to Discontinuation of Study Drug, Related AEs, Immune-related AEs (IrAEs) at Primary Endpoint - All Treated Participants
Deaths
|
6 participants
|
|
Number of Participants With Death, Serious Adverse Events (SAEs), Adverse Events (AEs) Leading to Discontinuation of Study Drug, Related AEs, Immune-related AEs (IrAEs) at Primary Endpoint - All Treated Participants
Deaths Due to Disease Progression
|
6 participants
|
|
Number of Participants With Death, Serious Adverse Events (SAEs), Adverse Events (AEs) Leading to Discontinuation of Study Drug, Related AEs, Immune-related AEs (IrAEs) at Primary Endpoint - All Treated Participants
SAEs
|
10 participants
|
|
Number of Participants With Death, Serious Adverse Events (SAEs), Adverse Events (AEs) Leading to Discontinuation of Study Drug, Related AEs, Immune-related AEs (IrAEs) at Primary Endpoint - All Treated Participants
Treatment-Related SAEs
|
3 participants
|
|
Number of Participants With Death, Serious Adverse Events (SAEs), Adverse Events (AEs) Leading to Discontinuation of Study Drug, Related AEs, Immune-related AEs (IrAEs) at Primary Endpoint - All Treated Participants
AEs Leading to Discontinuation of Study Drug
|
1 participants
|
|
Number of Participants With Death, Serious Adverse Events (SAEs), Adverse Events (AEs) Leading to Discontinuation of Study Drug, Related AEs, Immune-related AEs (IrAEs) at Primary Endpoint - All Treated Participants
Grade 3/4 AEs
|
7 participants
|
|
Number of Participants With Death, Serious Adverse Events (SAEs), Adverse Events (AEs) Leading to Discontinuation of Study Drug, Related AEs, Immune-related AEs (IrAEs) at Primary Endpoint - All Treated Participants
Treatment-Related AEs
|
12 participants
|
|
Number of Participants With Death, Serious Adverse Events (SAEs), Adverse Events (AEs) Leading to Discontinuation of Study Drug, Related AEs, Immune-related AEs (IrAEs) at Primary Endpoint - All Treated Participants
Grade 3/4 Related AEs
|
3 participants
|
|
Number of Participants With Death, Serious Adverse Events (SAEs), Adverse Events (AEs) Leading to Discontinuation of Study Drug, Related AEs, Immune-related AEs (IrAEs) at Primary Endpoint - All Treated Participants
irAEs
|
12 participants
|
|
Number of Participants With Death, Serious Adverse Events (SAEs), Adverse Events (AEs) Leading to Discontinuation of Study Drug, Related AEs, Immune-related AEs (IrAEs) at Primary Endpoint - All Treated Participants
Grade 3/4 irAEs
|
2 participants
|
SECONDARY outcome
Timeframe: Day 1 to 90 Days after the last dose, up to July 2014Population: All participants in the study who received at least one dose of treatment with ipilimumab were summarized.
AEs graded using National Cancer Institute 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 AEs (irAEs) characterized by potential association with inflammation and considered by investigator as drug related.
Outcome measures
| Measure |
Ipilimumab
n=20 Participants
During treatment, participants received Ipilimumab intravenous (IV) injection 3 mg/kg every 3 weeks, up to 4 doses (12 weeks). Study was divided into 4 Phases: Screening Phase, Induction Phase, Toxicity/Progressive Disease(PD) Follow Up Phase, and Overall Survival Phase. The Induction Phase consisted of treatment and a 12 week post dosing follow up. It started at first dose and ended at Week 24, or earlier if participant discontinued treatment and moved to Follow-Up Phase.
|
|---|---|
|
Number of Participants With Death, Serious Adverse Events (SAEs), Adverse Events (AEs) Leading to Discontinuation of Study Drug, Related AEs, Immune-related AEs (IrAEs) - All Treated Participants
Deaths
|
8 participants
|
|
Number of Participants With Death, Serious Adverse Events (SAEs), Adverse Events (AEs) Leading to Discontinuation of Study Drug, Related AEs, Immune-related AEs (IrAEs) - All Treated Participants
Deaths Due to Disease Progression
|
8 participants
|
|
Number of Participants With Death, Serious Adverse Events (SAEs), Adverse Events (AEs) Leading to Discontinuation of Study Drug, Related AEs, Immune-related AEs (IrAEs) - All Treated Participants
SAEs
|
11 participants
|
|
Number of Participants With Death, Serious Adverse Events (SAEs), Adverse Events (AEs) Leading to Discontinuation of Study Drug, Related AEs, Immune-related AEs (IrAEs) - All Treated Participants
Treatment-Related SAEs
|
3 participants
|
|
Number of Participants With Death, Serious Adverse Events (SAEs), Adverse Events (AEs) Leading to Discontinuation of Study Drug, Related AEs, Immune-related AEs (IrAEs) - All Treated Participants
AEs Leading to Discontinuation of Study Drug
|
1 participants
|
|
Number of Participants With Death, Serious Adverse Events (SAEs), Adverse Events (AEs) Leading to Discontinuation of Study Drug, Related AEs, Immune-related AEs (IrAEs) - All Treated Participants
Grade 3/4 AEs
|
9 participants
|
|
Number of Participants With Death, Serious Adverse Events (SAEs), Adverse Events (AEs) Leading to Discontinuation of Study Drug, Related AEs, Immune-related AEs (IrAEs) - All Treated Participants
Treatment-Related AEs
|
12 participants
|
|
Number of Participants With Death, Serious Adverse Events (SAEs), Adverse Events (AEs) Leading to Discontinuation of Study Drug, Related AEs, Immune-related AEs (IrAEs) - All Treated Participants
Grade 3/4 Related AEs
|
3 participants
|
|
Number of Participants With Death, Serious Adverse Events (SAEs), Adverse Events (AEs) Leading to Discontinuation of Study Drug, Related AEs, Immune-related AEs (IrAEs) - All Treated Participants
irAEs
|
12 participants
|
|
Number of Participants With Death, Serious Adverse Events (SAEs), Adverse Events (AEs) Leading to Discontinuation of Study Drug, Related AEs, Immune-related AEs (IrAEs) - All Treated Participants
Grade 3/4 irAEs
|
3 participants
|
SECONDARY outcome
Timeframe: Day 1 to 90 days post last dose, up to February 2015 (approximately 2 years)Population: All participants in the study who received at least one dose of treatment with ipilimumab were summarized.
Total number of deaths that occurred in all treated participants by study completion are reported.
Outcome measures
| Measure |
Ipilimumab
n=20 Participants
During treatment, participants received Ipilimumab intravenous (IV) injection 3 mg/kg every 3 weeks, up to 4 doses (12 weeks). Study was divided into 4 Phases: Screening Phase, Induction Phase, Toxicity/Progressive Disease(PD) Follow Up Phase, and Overall Survival Phase. The Induction Phase consisted of treatment and a 12 week post dosing follow up. It started at first dose and ended at Week 24, or earlier if participant discontinued treatment and moved to Follow-Up Phase.
|
|---|---|
|
Number of Participants Who Died - All Treated Participants
Deaths within 90 days of last dose
|
5 participants
|
|
Number of Participants Who Died - All Treated Participants
Deaths at greater than 90 days post last dose
|
8 participants
|
SECONDARY outcome
Timeframe: Baseline to 90 days post last dose, up to July 2014Population: All participants in the study who received at least one dose of treatment with ipilimumab and had laboratory data were summarized. Data included up to July 2014.
Abnormal laboratory results were reported after the induction period start and within 90 days after induction period end date. Induction Period was 1 dose every 3 weeks for 4 doses (12 weeks). Common Terminology Criteria (CTC) version 3.0 was used in this study; Grade (Gr) 1=Mild, Gr 2=Moderate, Gr 3=Severe, Gr 4= Potentially Life-threatening or disabling, Gr 5=Death. Hematology parameters included: White Blood Cell Count (WBC), Absolute Neutrophil Count, Platelet Count, Hemoglobin, and Lymphocyte Count (absolute). The most recent assessment on or before Day 1 of study medication was taken as baseline (in addition, baseline laboratory must have been collected no earlier than Day -28).
Outcome measures
| Measure |
Ipilimumab
n=20 Participants
During treatment, participants received Ipilimumab intravenous (IV) injection 3 mg/kg every 3 weeks, up to 4 doses (12 weeks). Study was divided into 4 Phases: Screening Phase, Induction Phase, Toxicity/Progressive Disease(PD) Follow Up Phase, and Overall Survival Phase. The Induction Phase consisted of treatment and a 12 week post dosing follow up. It started at first dose and ended at Week 24, or earlier if participant discontinued treatment and moved to Follow-Up Phase.
|
|---|---|
|
Number of Participants With Hematology Laboratory Abnormalities
WBC Grade 1-4
|
1 participants
|
|
Number of Participants With Hematology Laboratory Abnormalities
WBC Grade 3-4
|
0 participants
|
|
Number of Participants With Hematology Laboratory Abnormalities
Absolute Neutophil Grade 1-4
|
1 participants
|
|
Number of Participants With Hematology Laboratory Abnormalities
Absolute Neutophil Grade 4-4
|
0 participants
|
|
Number of Participants With Hematology Laboratory Abnormalities
Platelet Count Grade 1-4
|
4 participants
|
|
Number of Participants With Hematology Laboratory Abnormalities
Platelet Count Grade 3-4
|
1 participants
|
|
Number of Participants With Hematology Laboratory Abnormalities
Hemoglobin Grade 1-4
|
15 participants
|
|
Number of Participants With Hematology Laboratory Abnormalities
Hemoglobin Grade 3-4
|
2 participants
|
|
Number of Participants With Hematology Laboratory Abnormalities
Lymphocytes Grade 1-4
|
13 participants
|
|
Number of Participants With Hematology Laboratory Abnormalities
Lymphocytes Grade 3-4
|
3 participants
|
SECONDARY outcome
Timeframe: Baseline to 90 days post last dose, up to July 2014Population: All participants in the study who received at least one dose of treatment with ipilimumab and had laboratory data were summarized. Data included up to July 2014.
Abnormal laboratory results were reported after the induction period start and within 90 days after induction period end date. Induction Period was 1 dose every 3 weeks for 4 doses (12 weeks). Common Terminology Criteria (CTC) version 3.0 was used in this study; Grade (Gr) 1=Mild, Gr 2=Moderate, Gr 3=Severe, Gr 4= Potentially Life-threatening or disabling, Gr 5=Death. Liver Function parameters included: alanine aminotransaminase (ALT), aspartate aminotransferase (AST), Total Bilirubin, and Alkaline Phosphatase (Alk Phos). The most recent assessment on or before Day 1 of study medication was taken as baseline (in addition, baseline laboratory must have been collected no earlier than Day -28).
Outcome measures
| Measure |
Ipilimumab
n=20 Participants
During treatment, participants received Ipilimumab intravenous (IV) injection 3 mg/kg every 3 weeks, up to 4 doses (12 weeks). Study was divided into 4 Phases: Screening Phase, Induction Phase, Toxicity/Progressive Disease(PD) Follow Up Phase, and Overall Survival Phase. The Induction Phase consisted of treatment and a 12 week post dosing follow up. It started at first dose and ended at Week 24, or earlier if participant discontinued treatment and moved to Follow-Up Phase.
|
|---|---|
|
Number of Participants With Liver Function Laboratory Abnormalities
ALT Grade 1-4
|
11 participants
|
|
Number of Participants With Liver Function Laboratory Abnormalities
ALT Grade 3-4
|
1 participants
|
|
Number of Participants With Liver Function Laboratory Abnormalities
AST Grade 1-4
|
10 participants
|
|
Number of Participants With Liver Function Laboratory Abnormalities
AST Grade 3-4
|
3 participants
|
|
Number of Participants With Liver Function Laboratory Abnormalities
Total Bilirubin Grade 1-4
|
3 participants
|
|
Number of Participants With Liver Function Laboratory Abnormalities
Total Bilirubin Grade 3-4
|
1 participants
|
|
Number of Participants With Liver Function Laboratory Abnormalities
Alk Phos Grade 1-4
|
10 participants
|
|
Number of Participants With Liver Function Laboratory Abnormalities
Alk Phos Grade 3-4
|
1 participants
|
SECONDARY outcome
Timeframe: Baseline to 90 days post last dose, up to July 2014Population: All participants in the study who received at least one dose of treatment with ipilimumab and had laboratory data were summarized. Data included up to July 2014.
Abnormal laboratory results were reported after the induction period start and within 90 days after induction period end date. Induction Period was 1 dose every 3 weeks for 4 doses (12 weeks). Common Terminology Criteria (CTC) version 3.0 was used in this study; Grade (Gr) 1=Mild, Gr 2=Moderate, Gr 3=Severe, Gr 4= Potentially Life-threatening or disabling, Gr 5=Death. Renal parameter=Creatinine. The most recent assessment on or before Day 1 of study medication was taken as baseline (in addition, baseline laboratory must have been collected no earlier than Day -28).
Outcome measures
| Measure |
Ipilimumab
n=20 Participants
During treatment, participants received Ipilimumab intravenous (IV) injection 3 mg/kg every 3 weeks, up to 4 doses (12 weeks). Study was divided into 4 Phases: Screening Phase, Induction Phase, Toxicity/Progressive Disease(PD) Follow Up Phase, and Overall Survival Phase. The Induction Phase consisted of treatment and a 12 week post dosing follow up. It started at first dose and ended at Week 24, or earlier if participant discontinued treatment and moved to Follow-Up Phase.
|
|---|---|
|
Number of Participants With Renal Laboratory Abnormalities
Creatinine Grade 1-4
|
5 participants
|
|
Number of Participants With Renal Laboratory Abnormalities
Creatinine Grade 3-4
|
1 participants
|
SECONDARY outcome
Timeframe: Day 1 to 90 days post last dose, up to February 2015 (approximately 2 years)Population: All participants in the study who received at least one dose of treatment with ipilimumab were summarized.
Overall response (OR) was determined using modified World Health Organization (mWHO) criteria. Complete response (CR): complete disappearance of all index and non-index lesions, and no new lesions. Partial response (PR): decrease in index lesions of 50% or greater in a sum of the products of diameters (SPD) relative to baseline, and no new lesions. Stable Disease (SD): Does not meet criteria for CR or PR, in the absence of PD in index lesions and no change or any change with persistence of one or more non-index lesions, and no new lesions. Progressive Disease (PD): At least 25% increase in SPD relative to nadir in index lesions and unequivocal progression of non-index lesions, along with new lesions or no new lesions; or PD: new lesions with any response with index or non-index lesions. Not Evaluable: Response cannot be determined.
Outcome measures
| Measure |
Ipilimumab
n=20 Participants
During treatment, participants received Ipilimumab intravenous (IV) injection 3 mg/kg every 3 weeks, up to 4 doses (12 weeks). Study was divided into 4 Phases: Screening Phase, Induction Phase, Toxicity/Progressive Disease(PD) Follow Up Phase, and Overall Survival Phase. The Induction Phase consisted of treatment and a 12 week post dosing follow up. It started at first dose and ended at Week 24, or earlier if participant discontinued treatment and moved to Follow-Up Phase.
|
|---|---|
|
Number of Participants With Complete Response, Partial Response, Stable Disease, or Progressive Disease as the Best Overall Response
Partial Response (PR)
|
2 participants
|
|
Number of Participants With Complete Response, Partial Response, Stable Disease, or Progressive Disease as the Best Overall Response
Stable Disease (SD)
|
2 participants
|
|
Number of Participants With Complete Response, Partial Response, Stable Disease, or Progressive Disease as the Best Overall Response
Progressive Disease (PD)
|
13 participants
|
|
Number of Participants With Complete Response, Partial Response, Stable Disease, or Progressive Disease as the Best Overall Response
Not Evaluable
|
3 participants
|
SECONDARY outcome
Timeframe: Day 1 to 90 days post last dose, up to February 2015 (approximately 2 years)Population: All participants in the study who received at least one dose of treatment with ipilimumab were summarized.
Best Overall Response Rate (BORR) was defined as the total number of participants whose Best Overall Response (BOR) is Complete Response (CR) or Partial Response (PR) divided by the total number of treated participants (%). A two-sided, exact 95% Confidence Interval (Clopper and Pearson) for the BORR was calculated. Overall response (OR) was determined using modified World Health Organization (mWHO) criteria: Complete Response = complete disappearance of all index and non-index lesions, and no new lesions. Partial Response = decrease in index lesions of 50% or greater in a SPD relative to baseline, and no new lesions. BOR=an overall response of CR or PR at Week 12 or after Week 12.
Outcome measures
| Measure |
Ipilimumab
n=20 Participants
During treatment, participants received Ipilimumab intravenous (IV) injection 3 mg/kg every 3 weeks, up to 4 doses (12 weeks). Study was divided into 4 Phases: Screening Phase, Induction Phase, Toxicity/Progressive Disease(PD) Follow Up Phase, and Overall Survival Phase. The Induction Phase consisted of treatment and a 12 week post dosing follow up. It started at first dose and ended at Week 24, or earlier if participant discontinued treatment and moved to Follow-Up Phase.
|
|---|---|
|
Percent of Participants With Best Overall Response (BOR) of Complete Response or Partial Response
|
10.0 percentage of participants
Interval 1.2 to 31.7
|
Adverse Events
Ipilimumab
Serious events: 11 serious events
Other events: 19 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Ipilimumab
n=20 participants at risk
During treatment, participants received Ipilimumab IV injection 3 mg/kg every 3 weeks, up to 4 doses (12 weeks). Study was divided into 4 Phases: Screening Phase, Induction Phase, Toxicity/Progressive Disease (PD) Follow Up Phase, and Overall Survival Phase. The Induction Phase consisted of treatment and a 12 week post dosing follow up. It started at first dose and ended at Week 24, or earlier if participant discontinued treatment and moved to Follow-Up Phase.
|
|---|---|
|
Investigations
C-reactive protein increased
|
5.0%
1/20 • Day 1 to 90 days post last dose, up to February 2015 (approximately 2 years)
Study initiated: December 2013; Study Completion: February 2015
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant neoplasm progression
|
10.0%
2/20 • Day 1 to 90 days post last dose, up to February 2015 (approximately 2 years)
Study initiated: December 2013; Study Completion: February 2015
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to meninges
|
5.0%
1/20 • Day 1 to 90 days post last dose, up to February 2015 (approximately 2 years)
Study initiated: December 2013; Study Completion: February 2015
|
|
General disorders
Multi-organ failure
|
5.0%
1/20 • Day 1 to 90 days post last dose, up to February 2015 (approximately 2 years)
Study initiated: December 2013; Study Completion: February 2015
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
5.0%
1/20 • Day 1 to 90 days post last dose, up to February 2015 (approximately 2 years)
Study initiated: December 2013; Study Completion: February 2015
|
|
Investigations
Aspartate aminotransferase increased
|
10.0%
2/20 • Day 1 to 90 days post last dose, up to February 2015 (approximately 2 years)
Study initiated: December 2013; Study Completion: February 2015
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
5.0%
1/20 • Day 1 to 90 days post last dose, up to February 2015 (approximately 2 years)
Study initiated: December 2013; Study Completion: February 2015
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic pain
|
5.0%
1/20 • Day 1 to 90 days post last dose, up to February 2015 (approximately 2 years)
Study initiated: December 2013; Study Completion: February 2015
|
|
Metabolism and nutrition disorders
Tumour lysis syndrome
|
5.0%
1/20 • Day 1 to 90 days post last dose, up to February 2015 (approximately 2 years)
Study initiated: December 2013; Study Completion: February 2015
|
|
Immune system disorders
Anaphylactic shock
|
5.0%
1/20 • Day 1 to 90 days post last dose, up to February 2015 (approximately 2 years)
Study initiated: December 2013; Study Completion: February 2015
|
|
Nervous system disorders
Brain oedema
|
5.0%
1/20 • Day 1 to 90 days post last dose, up to February 2015 (approximately 2 years)
Study initiated: December 2013; Study Completion: February 2015
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
5.0%
1/20 • Day 1 to 90 days post last dose, up to February 2015 (approximately 2 years)
Study initiated: December 2013; Study Completion: February 2015
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant melanoma
|
5.0%
1/20 • Day 1 to 90 days post last dose, up to February 2015 (approximately 2 years)
Study initiated: December 2013; Study Completion: February 2015
|
|
Investigations
Alanine aminotransferase increased
|
10.0%
2/20 • Day 1 to 90 days post last dose, up to February 2015 (approximately 2 years)
Study initiated: December 2013; Study Completion: February 2015
|
|
Nervous system disorders
Cerebral infarction
|
5.0%
1/20 • Day 1 to 90 days post last dose, up to February 2015 (approximately 2 years)
Study initiated: December 2013; Study Completion: February 2015
|
|
Infections and infestations
Erysipelas
|
5.0%
1/20 • Day 1 to 90 days post last dose, up to February 2015 (approximately 2 years)
Study initiated: December 2013; Study Completion: February 2015
|
|
Nervous system disorders
Hydrocephalus
|
5.0%
1/20 • Day 1 to 90 days post last dose, up to February 2015 (approximately 2 years)
Study initiated: December 2013; Study Completion: February 2015
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour pain
|
5.0%
1/20 • Day 1 to 90 days post last dose, up to February 2015 (approximately 2 years)
Study initiated: December 2013; Study Completion: February 2015
|
|
Gastrointestinal disorders
Ileus
|
5.0%
1/20 • Day 1 to 90 days post last dose, up to February 2015 (approximately 2 years)
Study initiated: December 2013; Study Completion: February 2015
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
5.0%
1/20 • Day 1 to 90 days post last dose, up to February 2015 (approximately 2 years)
Study initiated: December 2013; Study Completion: February 2015
|
|
Vascular disorders
Deep vein thrombosis
|
5.0%
1/20 • Day 1 to 90 days post last dose, up to February 2015 (approximately 2 years)
Study initiated: December 2013; Study Completion: February 2015
|
Other adverse events
| Measure |
Ipilimumab
n=20 participants at risk
During treatment, participants received Ipilimumab IV injection 3 mg/kg every 3 weeks, up to 4 doses (12 weeks). Study was divided into 4 Phases: Screening Phase, Induction Phase, Toxicity/Progressive Disease (PD) Follow Up Phase, and Overall Survival Phase. The Induction Phase consisted of treatment and a 12 week post dosing follow up. It started at first dose and ended at Week 24, or earlier if participant discontinued treatment and moved to Follow-Up Phase.
|
|---|---|
|
Gastrointestinal disorders
Abdominal pain upper
|
10.0%
2/20 • Day 1 to 90 days post last dose, up to February 2015 (approximately 2 years)
Study initiated: December 2013; Study Completion: February 2015
|
|
Investigations
Blood bilirubin increased
|
5.0%
1/20 • Day 1 to 90 days post last dose, up to February 2015 (approximately 2 years)
Study initiated: December 2013; Study Completion: February 2015
|
|
Investigations
C-reactive protein increased
|
5.0%
1/20 • Day 1 to 90 days post last dose, up to February 2015 (approximately 2 years)
Study initiated: December 2013; Study Completion: February 2015
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer pain
|
5.0%
1/20 • Day 1 to 90 days post last dose, up to February 2015 (approximately 2 years)
Study initiated: December 2013; Study Completion: February 2015
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
5.0%
1/20 • Day 1 to 90 days post last dose, up to February 2015 (approximately 2 years)
Study initiated: December 2013; Study Completion: February 2015
|
|
Respiratory, thoracic and mediastinal disorders
Emphysema
|
5.0%
1/20 • Day 1 to 90 days post last dose, up to February 2015 (approximately 2 years)
Study initiated: December 2013; Study Completion: February 2015
|
|
Musculoskeletal and connective tissue disorders
Groin pain
|
5.0%
1/20 • Day 1 to 90 days post last dose, up to February 2015 (approximately 2 years)
Study initiated: December 2013; Study Completion: February 2015
|
|
Gastrointestinal disorders
Haemorrhoids
|
5.0%
1/20 • Day 1 to 90 days post last dose, up to February 2015 (approximately 2 years)
Study initiated: December 2013; Study Completion: February 2015
|
|
Vascular disorders
Hot flush
|
5.0%
1/20 • Day 1 to 90 days post last dose, up to February 2015 (approximately 2 years)
Study initiated: December 2013; Study Completion: February 2015
|
|
Vascular disorders
Lymphoedema
|
5.0%
1/20 • Day 1 to 90 days post last dose, up to February 2015 (approximately 2 years)
Study initiated: December 2013; Study Completion: February 2015
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to meninges
|
5.0%
1/20 • Day 1 to 90 days post last dose, up to February 2015 (approximately 2 years)
Study initiated: December 2013; Study Completion: February 2015
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal discomfort
|
5.0%
1/20 • Day 1 to 90 days post last dose, up to February 2015 (approximately 2 years)
Study initiated: December 2013; Study Completion: February 2015
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
5.0%
1/20 • Day 1 to 90 days post last dose, up to February 2015 (approximately 2 years)
Study initiated: December 2013; Study Completion: February 2015
|
|
Investigations
Weight decreased
|
10.0%
2/20 • Day 1 to 90 days post last dose, up to February 2015 (approximately 2 years)
Study initiated: December 2013; Study Completion: February 2015
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
15.0%
3/20 • Day 1 to 90 days post last dose, up to February 2015 (approximately 2 years)
Study initiated: December 2013; Study Completion: February 2015
|
|
Gastrointestinal disorders
Dry mouth
|
5.0%
1/20 • Day 1 to 90 days post last dose, up to February 2015 (approximately 2 years)
Study initiated: December 2013; Study Completion: February 2015
|
|
Investigations
Gamma-glutamyltransferase increased
|
5.0%
1/20 • Day 1 to 90 days post last dose, up to February 2015 (approximately 2 years)
Study initiated: December 2013; Study Completion: February 2015
|
|
Nervous system disorders
Headache
|
5.0%
1/20 • Day 1 to 90 days post last dose, up to February 2015 (approximately 2 years)
Study initiated: December 2013; Study Completion: February 2015
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
5.0%
1/20 • Day 1 to 90 days post last dose, up to February 2015 (approximately 2 years)
Study initiated: December 2013; Study Completion: February 2015
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
5.0%
1/20 • Day 1 to 90 days post last dose, up to February 2015 (approximately 2 years)
Study initiated: December 2013; Study Completion: February 2015
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
5.0%
1/20 • Day 1 to 90 days post last dose, up to February 2015 (approximately 2 years)
Study initiated: December 2013; Study Completion: February 2015
|
|
Infections and infestations
Upper respiratory tract infection
|
5.0%
1/20 • Day 1 to 90 days post last dose, up to February 2015 (approximately 2 years)
Study initiated: December 2013; Study Completion: February 2015
|
|
Gastrointestinal disorders
Abdominal pain
|
10.0%
2/20 • Day 1 to 90 days post last dose, up to February 2015 (approximately 2 years)
Study initiated: December 2013; Study Completion: February 2015
|
|
Investigations
Amylase increased
|
5.0%
1/20 • Day 1 to 90 days post last dose, up to February 2015 (approximately 2 years)
Study initiated: December 2013; Study Completion: February 2015
|
|
Investigations
Aspartate aminotransferase increased
|
20.0%
4/20 • Day 1 to 90 days post last dose, up to February 2015 (approximately 2 years)
Study initiated: December 2013; Study Completion: February 2015
|
|
Psychiatric disorders
Confusional state
|
10.0%
2/20 • Day 1 to 90 days post last dose, up to February 2015 (approximately 2 years)
Study initiated: December 2013; Study Completion: February 2015
|
|
Eye disorders
Conjunctivitis allergic
|
5.0%
1/20 • Day 1 to 90 days post last dose, up to February 2015 (approximately 2 years)
Study initiated: December 2013; Study Completion: February 2015
|
|
Psychiatric disorders
Delirium
|
5.0%
1/20 • Day 1 to 90 days post last dose, up to February 2015 (approximately 2 years)
Study initiated: December 2013; Study Completion: February 2015
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
10.0%
2/20 • Day 1 to 90 days post last dose, up to February 2015 (approximately 2 years)
Study initiated: December 2013; Study Completion: February 2015
|
|
Investigations
Haemoglobin decreased
|
5.0%
1/20 • Day 1 to 90 days post last dose, up to February 2015 (approximately 2 years)
Study initiated: December 2013; Study Completion: February 2015
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
5.0%
1/20 • Day 1 to 90 days post last dose, up to February 2015 (approximately 2 years)
Study initiated: December 2013; Study Completion: February 2015
|
|
Infections and infestations
Pneumocystis jirovecii pneumonia
|
5.0%
1/20 • Day 1 to 90 days post last dose, up to February 2015 (approximately 2 years)
Study initiated: December 2013; Study Completion: February 2015
|
|
Skin and subcutaneous tissue disorders
Toxic skin eruption
|
5.0%
1/20 • Day 1 to 90 days post last dose, up to February 2015 (approximately 2 years)
Study initiated: December 2013; Study Completion: February 2015
|
|
Investigations
Blood sodium decreased
|
5.0%
1/20 • Day 1 to 90 days post last dose, up to February 2015 (approximately 2 years)
Study initiated: December 2013; Study Completion: February 2015
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
5.0%
1/20 • Day 1 to 90 days post last dose, up to February 2015 (approximately 2 years)
Study initiated: December 2013; Study Completion: February 2015
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
10.0%
2/20 • Day 1 to 90 days post last dose, up to February 2015 (approximately 2 years)
Study initiated: December 2013; Study Completion: February 2015
|
|
Infections and infestations
Otitis externa
|
5.0%
1/20 • Day 1 to 90 days post last dose, up to February 2015 (approximately 2 years)
Study initiated: December 2013; Study Completion: February 2015
|
|
Musculoskeletal and connective tissue disorders
Pathological fracture
|
5.0%
1/20 • Day 1 to 90 days post last dose, up to February 2015 (approximately 2 years)
Study initiated: December 2013; Study Completion: February 2015
|
|
Investigations
Platelet count decreased
|
5.0%
1/20 • Day 1 to 90 days post last dose, up to February 2015 (approximately 2 years)
Study initiated: December 2013; Study Completion: February 2015
|
|
Investigations
Alanine aminotransferase increased
|
20.0%
4/20 • Day 1 to 90 days post last dose, up to February 2015 (approximately 2 years)
Study initiated: December 2013; Study Completion: February 2015
|
|
Skin and subcutaneous tissue disorders
Eczema asteatotic
|
5.0%
1/20 • Day 1 to 90 days post last dose, up to February 2015 (approximately 2 years)
Study initiated: December 2013; Study Completion: February 2015
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
5.0%
1/20 • Day 1 to 90 days post last dose, up to February 2015 (approximately 2 years)
Study initiated: December 2013; Study Completion: February 2015
|
|
Infections and infestations
Nasopharyngitis
|
5.0%
1/20 • Day 1 to 90 days post last dose, up to February 2015 (approximately 2 years)
Study initiated: December 2013; Study Completion: February 2015
|
|
Gastrointestinal disorders
Nausea
|
5.0%
1/20 • Day 1 to 90 days post last dose, up to February 2015 (approximately 2 years)
Study initiated: December 2013; Study Completion: February 2015
|
|
Infections and infestations
Oral herpes
|
5.0%
1/20 • Day 1 to 90 days post last dose, up to February 2015 (approximately 2 years)
Study initiated: December 2013; Study Completion: February 2015
|
|
Skin and subcutaneous tissue disorders
Rash
|
40.0%
8/20 • Day 1 to 90 days post last dose, up to February 2015 (approximately 2 years)
Study initiated: December 2013; Study Completion: February 2015
|
|
Nervous system disorders
Somnolence
|
10.0%
2/20 • Day 1 to 90 days post last dose, up to February 2015 (approximately 2 years)
Study initiated: December 2013; Study Completion: February 2015
|
|
Nervous system disorders
VIth nerve paralysis
|
5.0%
1/20 • Day 1 to 90 days post last dose, up to February 2015 (approximately 2 years)
Study initiated: December 2013; Study Completion: February 2015
|
|
Skin and subcutaneous tissue disorders
Acne
|
5.0%
1/20 • Day 1 to 90 days post last dose, up to February 2015 (approximately 2 years)
Study initiated: December 2013; Study Completion: February 2015
|
|
Nervous system disorders
Cerebral infarction
|
5.0%
1/20 • Day 1 to 90 days post last dose, up to February 2015 (approximately 2 years)
Study initiated: December 2013; Study Completion: February 2015
|
|
Infections and infestations
Conjunctivitis
|
5.0%
1/20 • Day 1 to 90 days post last dose, up to February 2015 (approximately 2 years)
Study initiated: December 2013; Study Completion: February 2015
|
|
Gastrointestinal disorders
Diarrhoea
|
20.0%
4/20 • Day 1 to 90 days post last dose, up to February 2015 (approximately 2 years)
Study initiated: December 2013; Study Completion: February 2015
|
|
Infections and infestations
Erysipelas
|
5.0%
1/20 • Day 1 to 90 days post last dose, up to February 2015 (approximately 2 years)
Study initiated: December 2013; Study Completion: February 2015
|
|
General disorders
Fatigue
|
5.0%
1/20 • Day 1 to 90 days post last dose, up to February 2015 (approximately 2 years)
Study initiated: December 2013; Study Completion: February 2015
|
|
Immune system disorders
Hypersensitivity
|
5.0%
1/20 • Day 1 to 90 days post last dose, up to February 2015 (approximately 2 years)
Study initiated: December 2013; Study Completion: February 2015
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
5.0%
1/20 • Day 1 to 90 days post last dose, up to February 2015 (approximately 2 years)
Study initiated: December 2013; Study Completion: February 2015
|
|
Psychiatric disorders
Insomnia
|
15.0%
3/20 • Day 1 to 90 days post last dose, up to February 2015 (approximately 2 years)
Study initiated: December 2013; Study Completion: February 2015
|
|
General disorders
Malaise
|
15.0%
3/20 • Day 1 to 90 days post last dose, up to February 2015 (approximately 2 years)
Study initiated: December 2013; Study Completion: February 2015
|
|
General disorders
Mucosal inflammation
|
10.0%
2/20 • Day 1 to 90 days post last dose, up to February 2015 (approximately 2 years)
Study initiated: December 2013; Study Completion: February 2015
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
10.0%
2/20 • Day 1 to 90 days post last dose, up to February 2015 (approximately 2 years)
Study initiated: December 2013; Study Completion: February 2015
|
|
General disorders
Pyrexia
|
30.0%
6/20 • Day 1 to 90 days post last dose, up to February 2015 (approximately 2 years)
Study initiated: December 2013; Study Completion: February 2015
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour pain
|
15.0%
3/20 • Day 1 to 90 days post last dose, up to February 2015 (approximately 2 years)
Study initiated: December 2013; Study Completion: February 2015
|
|
Renal and urinary disorders
Urinary retention
|
5.0%
1/20 • Day 1 to 90 days post last dose, up to February 2015 (approximately 2 years)
Study initiated: December 2013; Study Completion: February 2015
|
|
Gastrointestinal disorders
Constipation
|
15.0%
3/20 • Day 1 to 90 days post last dose, up to February 2015 (approximately 2 years)
Study initiated: December 2013; Study Completion: February 2015
|
|
Blood and lymphatic system disorders
Disseminated intravascular coagulation
|
5.0%
1/20 • Day 1 to 90 days post last dose, up to February 2015 (approximately 2 years)
Study initiated: December 2013; Study Completion: February 2015
|
|
Nervous system disorders
Dysgeusia
|
5.0%
1/20 • Day 1 to 90 days post last dose, up to February 2015 (approximately 2 years)
Study initiated: December 2013; Study Completion: February 2015
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
5.0%
1/20 • Day 1 to 90 days post last dose, up to February 2015 (approximately 2 years)
Study initiated: December 2013; Study Completion: February 2015
|
|
General disorders
Oedema peripheral
|
5.0%
1/20 • Day 1 to 90 days post last dose, up to February 2015 (approximately 2 years)
Study initiated: December 2013; Study Completion: February 2015
|
|
Psychiatric disorders
Anxiety
|
5.0%
1/20 • Day 1 to 90 days post last dose, up to February 2015 (approximately 2 years)
Study initiated: December 2013; Study Completion: February 2015
|
|
Gastrointestinal disorders
Ascites
|
5.0%
1/20 • Day 1 to 90 days post last dose, up to February 2015 (approximately 2 years)
Study initiated: December 2013; Study Completion: February 2015
|
|
Investigations
Blood alkaline phosphatase increased
|
5.0%
1/20 • Day 1 to 90 days post last dose, up to February 2015 (approximately 2 years)
Study initiated: December 2013; Study Completion: February 2015
|
|
Infections and infestations
Cellulitis
|
5.0%
1/20 • Day 1 to 90 days post last dose, up to February 2015 (approximately 2 years)
Study initiated: December 2013; Study Completion: February 2015
|
|
Metabolism and nutrition disorders
Decreased appetite
|
25.0%
5/20 • Day 1 to 90 days post last dose, up to February 2015 (approximately 2 years)
Study initiated: December 2013; Study Completion: February 2015
|
|
Vascular disorders
Deep vein thrombosis
|
10.0%
2/20 • Day 1 to 90 days post last dose, up to February 2015 (approximately 2 years)
Study initiated: December 2013; Study Completion: February 2015
|
|
Metabolism and nutrition disorders
Dehydration
|
5.0%
1/20 • Day 1 to 90 days post last dose, up to February 2015 (approximately 2 years)
Study initiated: December 2013; Study Completion: February 2015
|
|
Metabolism and nutrition disorders
Hyperlipidaemia
|
5.0%
1/20 • Day 1 to 90 days post last dose, up to February 2015 (approximately 2 years)
Study initiated: December 2013; Study Completion: February 2015
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
5.0%
1/20 • Day 1 to 90 days post last dose, up to February 2015 (approximately 2 years)
Study initiated: December 2013; Study Completion: February 2015
|
|
Injury, poisoning and procedural complications
Radiation skin injury
|
5.0%
1/20 • Day 1 to 90 days post last dose, up to February 2015 (approximately 2 years)
Study initiated: December 2013; Study Completion: February 2015
|
|
Gastrointestinal disorders
Vomiting
|
10.0%
2/20 • Day 1 to 90 days post last dose, up to February 2015 (approximately 2 years)
Study initiated: December 2013; Study Completion: February 2015
|
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