Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to determine whether Ipilimumab will extend the life of chinese patients with Chemotherapy Naive Stage IV Melanoma more than Dacarbazine as well as to examine safety in this patient population.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ipilimumab | Experimental | Intravenously (IV) 3 mg/kg every 3 weeks (at week 1,4,7,10) and thereafter (q3w/4 doses) at the time of progression |
|
| Dacarbazine | Experimental | IV solution 250 mg/m2 (Day 1-5, every 3weeks/at week 1, 4, 7, 10,13,16,19,22) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ipilimumab | Drug |
|
| |
| Dacarbazine |
| Measure | Description | Time Frame |
|---|---|---|
| Two-Years Survival Rate | Two-year survival rate is defined as the probability that a subject is alive at 2 years following the randomization date and will be estimated via the Kaplan-Meier (KM) method. | 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| One-Year Survival Rate | Survival rate at 1 year is defined as the probability that a subject is alive at 1 year following the randomization date and will be estimated via the Kaplan-Meier (KM) method. | Approximately 43 months |
| Overall Survival (OS) |
Not provided
For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Bristol-Myers Squibb | Bristol-Myers Squibb | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Local Institution | Nanjing | Jiangsu | 210000 | China | ||
| Local Institution |
Not provided
| Label | URL |
|---|---|
| BMS clinical trial educational resource | View source |
Not provided
182 participants were enrolled, 68 were not randomized, reasons for not being randomized:3 participants withdrew consent and 65 no longer meet study criteria.
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Ipilimumab (3 mg/kg) | Ipilimumab 3 mg/kg to be administered via intravenous infusion over 90 minutes at Weeks 1, 4, 7 and 10, for a total of four doses in Induction (and Re-Induction for those randomized to the ipilimumab arm who qualify) |
| FG001 | Dacarbazine (250 mg/m2) | DTIC 250 mg/m2 - Day 1 - 5, to be administered via intravenous infusion at Weeks 1, 4, 7, 10, 13, 16,19, and 22. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Randomization |
|
| |||||||||||||||||||||
| Treatment |
|
All randomized participants
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Ipilimumab (3 mg/kg) | Ipilimumab 3 mg/kg to be administered via intravenous infusion over 90 minutes at Weeks 1, 4, 7 and 10, for a total of four doses in Induction (and Re-Induction for those randomized to the ipilimumab arm who qualify) |
| BG001 | Dacarbazine (250 mg/m2) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | All randomized participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Two-Years Survival Rate | Two-year survival rate is defined as the probability that a subject is alive at 2 years following the randomization date and will be estimated via the Kaplan-Meier (KM) method. | All randomized participants | Posted | Number | 80% Confidence Interval | Percentage of Participants | 24 months |
|
Approximately 43 months
Adverse events are reported between first dose and 90 days after last dose of study therapy.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Ipilimumab | Ipilimumab 3 mg/kg to be administered via intravenous infusion over 90 minutes at Weeks 1, 4, 7 and 10, for a total of four doses in Induction (and Re-Induction for those randomized to the ipilimumab arm who qualify) |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 22.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 22.0 | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Bristol-Myers Squibb Study Director | Bristol-Myers Squibb | Please email | Clinical.Trials@bms.com |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| SAP | No | Yes | No | Statistical Analysis Plan | Jan 17, 2019 | Apr 13, 2020 | SAP_000.pdf |
| Prot | Yes | No | No | Study Protocol | Jun 28, 2019 | Apr 14, 2020 | Prot_001.pdf |
Not provided
| ID | Term |
|---|---|
| D008545 | Melanoma |
| ID | Term |
|---|---|
| D018358 | Neuroendocrine Tumors |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
Not provided
Not provided
| ID | Term |
|---|---|
| D000074324 | Ipilimumab |
| D003606 | Dacarbazine |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Drug |
|
|
OS is defined for each subject as the time between randomization date and the date of death (of any cause).
| Approximately 43 months |
| Progression Free Survival ( PFS) | PFS is defined for each subject as the time between randomization date and the date of progression or death, whichever occurs first. | Approximately 43 months |
| Disease Control Rate ( DCR ) | Primary DCR is defined as the number of subjects in the arm with Best Overall Response (BOR) of complete response (CR), partial response (PR), or stable disease (SD), divided by the total number of randomized subjects in the arm. | Approximately 43 months |
| Best Overall Response Rate ( BORR ) | BORR definition is defined as the number of subjects in the arm with a BOR of CR or PR, divided by the total number of randomized subjects in the arm. | Approximately 43 months |
| Duration of Response ( DoR) | DoR definition for the response evaluable subjects whose BOR is CR or PR is defined as the time between the date of response of CR or PR (whichever occurs first) and the first date of progressive disease (PD) or the date of death (whichever occurs first). | Approximately 43 months |
| Duration of Stable Disease ( DoSD ) | Primary duration of stable disease (DoSD) definition for the randomized subjects whose BOR is SD is defined as the time between the randomization date and the first date of PD or the date of death (whichever occurs first)." | Approximately 43 months |
| Changchun |
| Jilin |
| 130021 |
| China |
| Local Institution | Xi’an | Shanxi | 710038 | China |
| Local Institution | Tianjin | Tianjin Municipality | 300060 | China |
| Local Institution | Hanghzou | Zhejiang | China |
| Local Institution | Beijing | 100142 | China |
| Local Institution | Kunming | China |
| Local Institution | Shanghai | 200032 | China |
| NOT COMPLETED |
|
|
DTIC 250 mg/m2 - Day 1 - 5, to be administered via intravenous infusion at Weeks 1, 4, 7, 10, 13, 16,19, and 22. |
| BG002 | Total | Total of all reporting groups |
| Mean |
| Standard Deviation |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
|
|
|
| Secondary | One-Year Survival Rate | Survival rate at 1 year is defined as the probability that a subject is alive at 1 year following the randomization date and will be estimated via the Kaplan-Meier (KM) method. | All randomized participants | Posted | Number | 80% Confidence Interval | Percentage of Participants | Approximately 43 months |
|
|
|
|
| Secondary | Overall Survival (OS) | OS is defined for each subject as the time between randomization date and the date of death (of any cause). | All randomized participants | Posted | Median | 80% Confidence Interval | Months | Approximately 43 months |
|
|
|
|
| Secondary | Progression Free Survival ( PFS) | PFS is defined for each subject as the time between randomization date and the date of progression or death, whichever occurs first. | All randomized participants | Posted | Median | 80% Confidence Interval | Months | Approximately 43 months |
|
|
|
|
| Secondary | Disease Control Rate ( DCR ) | Primary DCR is defined as the number of subjects in the arm with Best Overall Response (BOR) of complete response (CR), partial response (PR), or stable disease (SD), divided by the total number of randomized subjects in the arm. | All randomized participants | Posted | Number | 80% Confidence Interval | Percentage of participants | Approximately 43 months |
|
|
|
|
| Secondary | Best Overall Response Rate ( BORR ) | BORR definition is defined as the number of subjects in the arm with a BOR of CR or PR, divided by the total number of randomized subjects in the arm. | All randomized participants | Posted | Number | 80% Confidence Interval | Percentage of participants | Approximately 43 months |
|
|
|
|
| Secondary | Duration of Response ( DoR) | DoR definition for the response evaluable subjects whose BOR is CR or PR is defined as the time between the date of response of CR or PR (whichever occurs first) and the first date of progressive disease (PD) or the date of death (whichever occurs first). | All randomized participants with response | Posted | Median | 80% Confidence Interval | Months | Approximately 43 months |
|
|
|
| Secondary | Duration of Stable Disease ( DoSD ) | Primary duration of stable disease (DoSD) definition for the randomized subjects whose BOR is SD is defined as the time between the randomization date and the first date of PD or the date of death (whichever occurs first)." | All randomized participants with BOR as stable disease | Posted | Median | 80% Confidence Interval | Months | Approximately 43 months |
|
|
|
| 93 |
| 122 |
| 34 |
| 122 |
| 118 |
| 122 |
| EG001 | Dacarbazine | DTIC 250 mg/m2 - Day 1 - 5, to be administered via intravenous infusion at Weeks 1, 4, 7, 10, 13, 16,19, and 22. | 39 | 53 | 12 | 53 | 48 | 53 |
| Bone marrow failure | Blood and lymphatic system disorders | MedDRA 22.0 | Systematic Assessment |
|
| Hypophysitis | Endocrine disorders | MedDRA 22.0 | Systematic Assessment |
|
| Hypopituitarism | Endocrine disorders | MedDRA 22.0 | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA 22.0 | Systematic Assessment |
|
| Ascites | Gastrointestinal disorders | MedDRA 22.0 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 22.0 | Systematic Assessment |
|
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 22.0 | Systematic Assessment |
|
| Haematemesis | Gastrointestinal disorders | MedDRA 22.0 | Systematic Assessment |
|
| Oedema peripheral | General disorders | MedDRA 22.0 | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA 22.0 | Systematic Assessment |
|
| Sudden death | General disorders | MedDRA 22.0 | Systematic Assessment |
|
| Cholecystitis acute | Hepatobiliary disorders | MedDRA 22.0 | Systematic Assessment |
|
| Hypersensitivity | Immune system disorders | MedDRA 22.0 | Systematic Assessment |
|
| Cellulitis | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
|
| Skin infection | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
|
| Overdose | Injury, poisoning and procedural complications | MedDRA 22.0 | Systematic Assessment |
|
| Wrist fracture | Injury, poisoning and procedural complications | MedDRA 22.0 | Systematic Assessment |
|
| Blood bilirubin increased | Investigations | MedDRA 22.0 | Systematic Assessment |
|
| Electrolyte imbalance | Metabolism and nutrition disorders | MedDRA 22.0 | Systematic Assessment |
|
| Hypoproteinaemia | Metabolism and nutrition disorders | MedDRA 22.0 | Systematic Assessment |
|
| Malignant neoplasm progression | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 22.0 | Systematic Assessment |
|
| Cerebral infarction | Nervous system disorders | MedDRA 22.0 | Systematic Assessment |
|
| Acute respiratory distress syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA 22.0 | Systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 22.0 | Systematic Assessment |
|
| Interstitial lung disease | Respiratory, thoracic and mediastinal disorders | MedDRA 22.0 | Systematic Assessment |
|
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 22.0 | Systematic Assessment |
|
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 22.0 | Systematic Assessment |
|
| Erythema | Skin and subcutaneous tissue disorders | MedDRA 22.0 | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA 22.0 | Systematic Assessment |
|
| Pelvic venous thrombosis | Vascular disorders | MedDRA 22.0 | Systematic Assessment |
|
| Bone marrow failure | Blood and lymphatic system disorders | MedDRA 22.0 | Systematic Assessment |
|
| Leukopenia | Blood and lymphatic system disorders | MedDRA 22.0 | Systematic Assessment |
|
| Neutropenia | Blood and lymphatic system disorders | MedDRA 22.0 | Systematic Assessment |
|
| Sinus bradycardia | Cardiac disorders | MedDRA 22.0 | Systematic Assessment |
|
| Supraventricular tachycardia | Cardiac disorders | MedDRA 22.0 | Systematic Assessment |
|
| Abdominal distension | Gastrointestinal disorders | MedDRA 22.0 | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA 22.0 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 22.0 | Systematic Assessment |
|
| Gastrointestinal disorder | Gastrointestinal disorders | MedDRA 22.0 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 22.0 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 22.0 | Systematic Assessment |
|
| Asthenia | General disorders | MedDRA 22.0 | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA 22.0 | Systematic Assessment |
|
| Oedema peripheral | General disorders | MedDRA 22.0 | Systematic Assessment |
|
| Pain | General disorders | MedDRA 22.0 | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA 22.0 | Systematic Assessment |
|
| Liver injury | Hepatobiliary disorders | MedDRA 22.0 | Systematic Assessment |
|
| Alanine aminotransferase increased | Investigations | MedDRA 22.0 | Systematic Assessment |
|
| Aspartate aminotransferase increased | Investigations | MedDRA 22.0 | Systematic Assessment |
|
| Bilirubin conjugated increased | Investigations | MedDRA 22.0 | Systematic Assessment |
|
| Blood albumin decreased | Investigations | MedDRA 22.0 | Systematic Assessment |
|
| Blood alkaline phosphatase increased | Investigations | MedDRA 22.0 | Systematic Assessment |
|
| Blood bilirubin increased | Investigations | MedDRA 22.0 | Systematic Assessment |
|
| Blood bilirubin unconjugated increased | Investigations | MedDRA 22.0 | Systematic Assessment |
|
| Blood chloride decreased | Investigations | MedDRA 22.0 | Systematic Assessment |
|
| Blood cholesterol increased | Investigations | MedDRA 22.0 | Systematic Assessment |
|
| Blood glucose increased | Investigations | MedDRA 22.0 | Systematic Assessment |
|
| Blood lactate dehydrogenase increased | Investigations | MedDRA 22.0 | Systematic Assessment |
|
| Blood potassium decreased | Investigations | MedDRA 22.0 | Systematic Assessment |
|
| Blood sodium decreased | Investigations | MedDRA 22.0 | Systematic Assessment |
|
| Blood thyroid stimulating hormone decreased | Investigations | MedDRA 22.0 | Systematic Assessment |
|
| Blood thyroid stimulating hormone increased | Investigations | MedDRA 22.0 | Systematic Assessment |
|
| Blood triglycerides increased | Investigations | MedDRA 22.0 | Systematic Assessment |
|
| Blood uric acid increased | Investigations | MedDRA 22.0 | Systematic Assessment |
|
| Blood urine present | Investigations | MedDRA 22.0 | Systematic Assessment |
|
| C-reactive protein increased | Investigations | MedDRA 22.0 | Systematic Assessment |
|
| Electrocardiogram T wave abnormal | Investigations | MedDRA 22.0 | Systematic Assessment |
|
| Gamma-glutamyltransferase increased | Investigations | MedDRA 22.0 | Systematic Assessment |
|
| Haemoglobin decreased | Investigations | MedDRA 22.0 | Systematic Assessment |
|
| Lymphocyte count decreased | Investigations | MedDRA 22.0 | Systematic Assessment |
|
| Neutrophil count decreased | Investigations | MedDRA 22.0 | Systematic Assessment |
|
| Neutrophil count increased | Investigations | MedDRA 22.0 | Systematic Assessment |
|
| Neutrophil percentage decreased | Investigations | MedDRA 22.0 | Systematic Assessment |
|
| Neutrophil percentage increased | Investigations | MedDRA 22.0 | Systematic Assessment |
|
| Platelet count decreased | Investigations | MedDRA 22.0 | Systematic Assessment |
|
| Platelet count increased | Investigations | MedDRA 22.0 | Systematic Assessment |
|
| Protein urine present | Investigations | MedDRA 22.0 | Systematic Assessment |
|
| Thyroxine free decreased | Investigations | MedDRA 22.0 | Systematic Assessment |
|
| Thyroxine free increased | Investigations | MedDRA 22.0 | Systematic Assessment |
|
| Tri-iodothyronine decreased | Investigations | MedDRA 22.0 | Systematic Assessment |
|
| Tri-iodothyronine free decreased | Investigations | MedDRA 22.0 | Systematic Assessment |
|
| Tri-iodothyronine free increased | Investigations | MedDRA 22.0 | Systematic Assessment |
|
| Weight decreased | Investigations | MedDRA 22.0 | Systematic Assessment |
|
| White blood cell count decreased | Investigations | MedDRA 22.0 | Systematic Assessment |
|
| White blood cell count increased | Investigations | MedDRA 22.0 | Systematic Assessment |
|
| White blood cells urine positive | Investigations | MedDRA 22.0 | Systematic Assessment |
|
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 22.0 | Systematic Assessment |
|
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 22.0 | Systematic Assessment |
|
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 22.0 | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 22.0 | Systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 22.0 | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA 22.0 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 22.0 | Systematic Assessment |
|
| Insomnia | Psychiatric disorders | MedDRA 22.0 | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 22.0 | Systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 22.0 | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA 22.0 | Systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA 22.0 | Systematic Assessment |
|
Not provided
| D009369 | Neoplasms |
| D009380 | Neoplasms, Nerve Tissue |
| D018326 | Nevi and Melanomas |
| D012878 | Skin Neoplasms |
| D009371 | Neoplasms by Site |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D007162 |
| Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D014226 | Triazenes |
| D009930 | Organic Chemicals |
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |