Melanoma
Conditions
Brief summary
The purpose of this study is to assess the safety of Ipilimumab monotherapy in Japanese subjects with advanced melanoma
Interventions
BIOLOGICALIpilimumab
Sponsors
Bristol-Myers Squibb
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
Inclusion criteria
For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com. Inclusion Criteria: * Histologically or cytologically confirmed diagnosis of malignant melanoma * Previously-treated or untreated unresectable Stage III or Stage IV melanoma * Measurable/evaluable disease per modified World Health Organization (mWHO) criteria, within 28 days of first dose of study drug * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Exclusion criteria
* Active brain metastases * Primary ocular or mucosal melanoma * History of or current active autoimmune disease
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 | Day 1 to 90 Days after the last dose, up to May 2014 | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Who Died - All Treated Participants | Day 1 to 90 days post last dose, up to February 2015 (approximately 2 years) | Total number of deaths that occurred in all treated participants by study completion are reported. |
| Number of Participants With Hematology Laboratory Abnormalities | Baseline to 90 days post last dose, 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). |
| Number of Participants With Liver Function Laboratory Abnormalities | Baseline to 90 days post last dose, 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). |
| 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 | Day 1 to 90 Days after the last dose, up to July 2014 | 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. |
| Number of Participants With Complete Response, Partial Response, Stable Disease, or Progressive Disease as the Best Overall Response | Day 1 to 90 days post last dose, up to February 2015 (approximately 2 years) | 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. |
| Percent of Participants With Best Overall Response (BOR) of Complete Response or Partial Response | Day 1 to 90 days post last dose, up to February 2015 (approximately 2 years) | 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. |
| Number of Participants With Renal Laboratory Abnormalities | Baseline to 90 days post last dose, 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). |
Countries
Japan
Participant flow
Recruitment details
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.
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| Ipilimumab Participants received Ipilimumab intravenous (IV) injection 3 mg/kg every 3 weeks, up to 4 doses. | 20 |
| Total | 20 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Treatment (4 Doses Over 12 Weeks) | Progressive Disease | 5 |
| Week 12 to Week 24 Post Dosing Follow Up | Disease Progression | 17 |
Baseline characteristics
| Characteristic | Ipilimumab |
|---|---|
| Age, Continuous | 62.5 years |
| Age, Customized Greater than, equal to 65 years | 7 participants |
| Age, Customized Less than 65 years | 13 participants |
| Baseline Lactate Dehydrogenase (LDH) Elevated | 12 participants |
| Baseline Lactate Dehydrogenase (LDH) Normal | 8 participants |
| Baseline LDH Greater than 2 Times Upper Limit of Normal Elevated | 7 participants |
| Baseline LDH Greater than 2 Times Upper Limit of Normal Normal | 13 participants |
| Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) ECOG PS 0 | 14 participants |
| Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) ECOG PS 1 | 6 participants |
| Height in centimeters (cm) | 161.7 cm |
| M-Stage at Study Entry M0 | 1 participants |
| M-Stage at Study Entry M1A | 1 participants |
| M-Stage at Study Entry M1B | 4 participants |
| M-Stage at Study Entry M1C | 14 participants |
| Prior Systemic Anti-Cancer Therapy No | 4 participants |
| Prior Systemic Anti-Cancer Therapy Yes | 16 participants |
| Race/Ethnicity, Customized Japanese | 20 participants |
| Region of Enrollment Japan | 20 participants |
| Sex: Female, Male Female | 10 Participants |
| Sex: Female, Male Male | 10 Participants |
| Weight in kilograms (kg) | 64.0 kg |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 19 / 20 |
| serious Total, serious adverse events | 11 / 20 |
Outcome results
Primary
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 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).
Time frame: Day 1 to 90 Days after the last dose, up to May 2014
Population: All participants in the study who received at least one dose of treatment with ipilimumab were summarized. Data up to May 2014 included.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Ipilimumab | 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 |
| Ipilimumab | 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 |
| Ipilimumab | 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 |
| Ipilimumab | 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 |
| Ipilimumab | 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 |
| Ipilimumab | 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 |
| Ipilimumab | 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 |
| Ipilimumab | 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 |
| Ipilimumab | 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 |
| Ipilimumab | 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
Number of Participants Who Died - All Treated Participants
Total number of deaths that occurred in all treated participants by study completion are reported.
Time frame: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Ipilimumab | Number of Participants Who Died - All Treated Participants | Deaths within 90 days of last dose | 5 participants |
| Ipilimumab | Number of Participants Who Died - All Treated Participants | Deaths at greater than 90 days post last dose | 8 participants |
Secondary
Number of Participants With Complete Response, Partial Response, Stable Disease, or Progressive Disease as the Best Overall Response
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.
Time frame: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Ipilimumab | Number of Participants With Complete Response, Partial Response, Stable Disease, or Progressive Disease as the Best Overall Response | Partial Response (PR) | 2 participants |
| Ipilimumab | Number of Participants With Complete Response, Partial Response, Stable Disease, or Progressive Disease as the Best Overall Response | Stable Disease (SD) | 2 participants |
| Ipilimumab | Number of Participants With Complete Response, Partial Response, Stable Disease, or Progressive Disease as the Best Overall Response | Progressive Disease (PD) | 13 participants |
| Ipilimumab | Number of Participants With Complete Response, Partial Response, Stable Disease, or Progressive Disease as the Best Overall Response | Not Evaluable | 3 participants |
Secondary
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 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.
Time frame: Day 1 to 90 Days after the last dose, up to July 2014
Population: All participants in the study who received at least one dose of treatment with ipilimumab were summarized.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Ipilimumab | 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 |
| Ipilimumab | 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 |
| Ipilimumab | 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 |
| Ipilimumab | 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 |
| Ipilimumab | 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 |
| Ipilimumab | 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 |
| Ipilimumab | 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 |
| Ipilimumab | 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 |
| Ipilimumab | 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 |
| Ipilimumab | 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 |
Secondary
Number of Participants With Hematology Laboratory Abnormalities
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).
Time frame: Baseline to 90 days post last dose, up to July 2014
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Ipilimumab | Number of Participants With Hematology Laboratory Abnormalities | WBC Grade 1-4 | 1 participants |
| Ipilimumab | Number of Participants With Hematology Laboratory Abnormalities | WBC Grade 3-4 | 0 participants |
| Ipilimumab | Number of Participants With Hematology Laboratory Abnormalities | Absolute Neutophil Grade 1-4 | 1 participants |
| Ipilimumab | Number of Participants With Hematology Laboratory Abnormalities | Absolute Neutophil Grade 4-4 | 0 participants |
| Ipilimumab | Number of Participants With Hematology Laboratory Abnormalities | Platelet Count Grade 1-4 | 4 participants |
| Ipilimumab | Number of Participants With Hematology Laboratory Abnormalities | Platelet Count Grade 3-4 | 1 participants |
| Ipilimumab | Number of Participants With Hematology Laboratory Abnormalities | Hemoglobin Grade 1-4 | 15 participants |
| Ipilimumab | Number of Participants With Hematology Laboratory Abnormalities | Hemoglobin Grade 3-4 | 2 participants |
| Ipilimumab | Number of Participants With Hematology Laboratory Abnormalities | Lymphocytes Grade 1-4 | 13 participants |
| Ipilimumab | Number of Participants With Hematology Laboratory Abnormalities | Lymphocytes Grade 3-4 | 3 participants |
Secondary
Number of Participants With Liver Function Laboratory Abnormalities
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).
Time frame: Baseline to 90 days post last dose, up to July 2014
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Ipilimumab | Number of Participants With Liver Function Laboratory Abnormalities | ALT Grade 1-4 | 11 participants |
| Ipilimumab | Number of Participants With Liver Function Laboratory Abnormalities | ALT Grade 3-4 | 1 participants |
| Ipilimumab | Number of Participants With Liver Function Laboratory Abnormalities | AST Grade 1-4 | 10 participants |
| Ipilimumab | Number of Participants With Liver Function Laboratory Abnormalities | AST Grade 3-4 | 3 participants |
| Ipilimumab | Number of Participants With Liver Function Laboratory Abnormalities | Total Bilirubin Grade 1-4 | 3 participants |
| Ipilimumab | Number of Participants With Liver Function Laboratory Abnormalities | Total Bilirubin Grade 3-4 | 1 participants |
| Ipilimumab | Number of Participants With Liver Function Laboratory Abnormalities | Alk Phos Grade 1-4 | 10 participants |
| Ipilimumab | Number of Participants With Liver Function Laboratory Abnormalities | Alk Phos Grade 3-4 | 1 participants |
Secondary
Number of Participants With Renal Laboratory Abnormalities
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).
Time frame: Baseline to 90 days post last dose, up to July 2014
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Ipilimumab | Number of Participants With Renal Laboratory Abnormalities | Creatinine Grade 1-4 | 5 participants |
| Ipilimumab | Number of Participants With Renal Laboratory Abnormalities | Creatinine Grade 3-4 | 1 participants |
Secondary
Percent of Participants With Best Overall Response (BOR) of Complete Response or Partial Response
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.
Time frame: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Ipilimumab | Percent of Participants With Best Overall Response (BOR) of Complete Response or Partial Response | 10.0 percentage of participants |