- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01990859
Phase 2 Study of Ipilimumab in Japanese Advanced Melanoma Patients
February 12, 2016 updated by: Bristol-Myers Squibb
Phase 2 Study of Ipilimumab in Japanese Subjects With Unresectable or Metastatic Melanoma
The purpose of this study is to assess the safety of Ipilimumab monotherapy in Japanese subjects with advanced melanoma
Study Overview
Study Type
Interventional
Enrollment (Actual)
20
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Fukuoka
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Fukuoka-shi, Fukuoka, Japan, 8128582
- Local Institution
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Kumamoto
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Kumamoto-shi, Kumamoto, Japan, 8608556
- Local Institution
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Nagano
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Matsumoto-shi, Nagano, Japan, 3908621
- Local Institution
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Shizuoka
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Sunto-gun, Shizuoka, Japan, 4118777
- Local Institution
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Tokyo
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Chuo-ku, Tokyo, Japan, 1040045
- Local Institution
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Yamanashi
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Chuo-shi, Yamanashi, Japan, 4093898
- Local Institution
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: Arm A: Ipilimumab
Ipilimumab Intravenous Injection 3 mg/kg for every 3 weeks upto 4 doses
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Other Names:
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What is the study measuring?
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
Time Frame: Day 1 to 90 Days after the last dose, up to May 2014
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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).
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Day 1 to 90 Days after the last dose, up to May 2014
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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
Time Frame: Day 1 to 90 Days after the last dose, up to July 2014
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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.
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Day 1 to 90 Days after the last dose, up to July 2014
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Number of Participants Who Died - All Treated Participants
Time Frame: Day 1 to 90 days post last dose, up to February 2015 (approximately 2 years)
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Total number of deaths that occurred in all treated participants by study completion are reported.
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Day 1 to 90 days post last dose, up to February 2015 (approximately 2 years)
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Number of Participants With Hematology Laboratory Abnormalities
Time Frame: Baseline to 90 days post last dose, up to July 2014
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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).
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Baseline to 90 days post last dose, up to July 2014
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Number of Participants With Liver Function Laboratory Abnormalities
Time Frame: Baseline to 90 days post last dose, up to July 2014
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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).
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Baseline to 90 days post last dose, up to July 2014
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Number of Participants With Renal Laboratory Abnormalities
Time Frame: Baseline to 90 days post last dose, up to July 2014
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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).
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Baseline to 90 days post last dose, up to July 2014
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Number of Participants With Complete Response, Partial Response, Stable Disease, or Progressive Disease as the Best Overall Response
Time Frame: Day 1 to 90 days post last dose, up to February 2015 (approximately 2 years)
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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.
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Day 1 to 90 days post last dose, up to February 2015 (approximately 2 years)
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Percent of Participants With Best Overall Response (BOR) of Complete Response or Partial Response
Time Frame: Day 1 to 90 days post last dose, up to February 2015 (approximately 2 years)
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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.
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Day 1 to 90 days post last dose, up to February 2015 (approximately 2 years)
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
December 1, 2013
Primary Completion (Actual)
May 1, 2014
Study Completion (Actual)
February 1, 2015
Study Registration Dates
First Submitted
November 18, 2013
First Submitted That Met QC Criteria
November 18, 2013
First Posted (Estimate)
November 25, 2013
Study Record Updates
Last Update Posted (Estimate)
March 14, 2016
Last Update Submitted That Met QC Criteria
February 12, 2016
Last Verified
February 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Neoplasms by Histologic Type
- Neoplasms
- Neuroectodermal Tumors
- Neoplasms, Germ Cell and Embryonal
- Neoplasms, Nerve Tissue
- Neuroendocrine Tumors
- Nevi and Melanomas
- Melanoma
- Molecular Mechanisms of Pharmacological Action
- Antineoplastic Agents
- Antineoplastic Agents, Immunological
- Immune Checkpoint Inhibitors
- Ipilimumab
Other Study ID Numbers
- CA184-396
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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