Phase 2 Study of Ipilimumab in Japanese Advanced Melanoma Patients

Study Overview
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Brief Summary
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The purpose of this study is to assess the safety of Ipilimumab monotherapy in Japanese subjects with advanced melanoma

Official Title
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Phase 2 Study of Ipilimumab in Japanese Subjects With Unresectable or Metastatic Melanoma

Conditions
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Melanoma

Intervention / Treatment
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* Biological: Ipilimumab


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm A: Ipilimumab<br>Ipilimumab Intravenous Injection 3 mg/kg for every 3 weeks upto 4 doses | Biological: Ipilimumab<br> <br> * Other names: BMS-734016;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | Day 1 to 90 Days after the last dose, up to May 2014 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Day 1 to 90 Days after the last dose, up to July 2014 | 
| Number of Participants Who Died - All Treated Participants | Total number of deaths that occurred in all treated participants by study completion are reported. | Day 1 to 90 days post last dose, up to February 2015 (approximately 2 years) | 
| 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). | Baseline to 90 days post last dose, up to July 2014 | 
| 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). | Baseline to 90 days post last dose, up to July 2014 | 
| 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). | Baseline to 90 days post last dose, up to July 2014 | 
| 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. | Day 1 to 90 days post last dose, up to February 2015 (approximately 2 years) | 
| 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. | Day 1 to 90 days post last dose, up to February 2015 (approximately 2 years) |