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A Comparative Study in Chinese Subjects With Chemotherapy Naïve Stage IV Melanoma Receiving Ipilimumab (3 mg/kg) vs. Dacarbazine
Phase 3 trial testing Ipilimumab in Melanoma in 182 participants. Completed in 19 April 2019.
| Lead sponsor | Bristol-Myers Squibb |
|---|---|
| Phase | Phase 3 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 182 |
| Start date | 31 October 2015 |
| Primary completion | 19 April 2019 |
| Estimated completion | 19 April 2019 |
| Sites | 8 locations across China |
Bristol-Myers Squibb — full company profile →
18 and older, any sex, with Melanoma. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
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.
| Group | Value | 95% CI |
|---|---|---|
| Ipilimumab (3 mg/kg) | 33.98 | 28.36 – 39.67 |
| Dacarbazine (250 mg/m2) | 34.09 | 25.72 – 42.62 |
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.
| Group | Value | 95% CI |
|---|---|---|
| Ipilimumab (3 mg/kg) | 61.68 | 55.71 – 67.09 |
| Dacarbazine (250 mg/m2) | 64.11 | 54.99 – 71.87 |
OS is defined for each subject as the time between randomization date and the date of death (of any cause).
| Group | Value | 95% CI |
|---|---|---|
| Ipilimumab (3 mg/kg) | 15.08 | 12.91 – 16.10 |
| Dacarbazine (250 mg/m2) | 14.55 | 13.37 – 19.19 |
PFS is defined for each subject as the time between randomization date and the date of progression or death, whichever occurs first.
| Group | Value | 95% CI |
|---|---|---|
| Ipilimumab (3 mg/kg) | 2.60 | 2.60 – 2.63 |
| Dacarbazine (250 mg/m2) | 1.84 | 1.41 – 2.63 |
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.
| Group | Value | 95% CI |
|---|---|---|
| Ipilimumab (3 mg/kg) | 32 | 26.4 – 38.0 |
| Dacarbazine (250 mg/m2) | 31.7 | 23.7 – 40.6 |
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.
| Group | Value | 95% CI |
|---|---|---|
| Ipilimumab (3 mg/kg) | 8.2 | 5.2 – 12.3 |
| Dacarbazine (250 mg/m2) | 8.3 | 4.1 – 14.9 |
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).
| Group | Value | 95% CI |
|---|---|---|
| Ipilimumab (3 mg/kg) | 8.99 | 4.76 – 29.01 |
| Dacarbazine (250 mg/m2) | 7.98 | 1.45 – NA |
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)."
| Group | Value | 95% CI |
|---|---|---|
| Ipilimumab (3 mg/kg) | 6.83 | 5.29 – 7.62 |
| Dacarbazine (250 mg/m2) | 9.40 | 5.26 – 16.30 |
Time frame: Approximately 43 months. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | Ipilimumab | Dacarbazine |
|---|---|---|---|
| Malignant neoplasm progression | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | — | — |
| Abdominal pain | Gastrointestinal disorders | — | — |
| Diarrhoea | Gastrointestinal disorders | — | — |
| Rash | Skin and subcutaneous tissue disorders | — | — |
| Anaemia | Blood and lymphatic system disorders | — | — |
| Bone marrow failure | Blood and lymphatic system disorders | — | — |
| Hypophysitis | Endocrine disorders | — | — |
| Hypopituitarism | Endocrine disorders | — | — |
| Ascites | Gastrointestinal disorders | — | — |
| Gastrointestinal haemorrhage | Gastrointestinal disorders | — | — |
| Haematemesis | Gastrointestinal disorders | — | — |
| Oedema peripheral | General disorders | — | — |
| Pyrexia | General disorders | — | — |
| Sudden death | General disorders | — | — |
| Cholecystitis acute | Hepatobiliary disorders | — | — |
| Hypersensitivity | Immune system disorders | — | — |
| Cellulitis | Infections and infestations | — | — |
| Skin infection | Infections and infestations | — | — |
| Overdose | Injury, poisoning and procedural complications | — | — |
| Wrist fracture | Injury, poisoning and procedural complications | — | — |
| Blood bilirubin increased | Investigations | — | — |
| Electrolyte imbalance | Metabolism and nutrition disorders | — | — |
| Hypoproteinaemia | Metabolism and nutrition disorders | — | — |
| Cerebral infarction | Nervous system disorders | — | — |
| Acute respiratory distress syndrome | Respiratory, thoracic and mediastinal disorders | — | — |
| Reaction | System | Ipilimumab | Dacarbazine |
|---|---|---|---|
| Rash | Skin and subcutaneous tissue disorders | — | — |
| Alanine aminotransferase increased | Investigations | — | — |
| Blood lactate dehydrogenase increased | Investigations | — | — |
| Blood thyroid stimulating hormone increased | Investigations | — | — |
| Decreased appetite | Metabolism and nutrition disorders | — | — |
| Pruritus | Skin and subcutaneous tissue disorders | — | — |
| C-reactive protein increased | Investigations | — | — |
| Pyrexia | General disorders | — | — |
| Nausea | Gastrointestinal disorders | — | — |
| Aspartate aminotransferase increased | Investigations | — | — |
| Haemoglobin decreased | Investigations | — | — |
| White blood cell count increased | Investigations | — | — |
| Weight decreased | Investigations | — | — |
| Gamma-glutamyltransferase increased | Investigations | — | — |
| Neutrophil count increased | Investigations | — | — |
| Pain | General disorders | — | — |
| Blood albumin decreased | Investigations | — | — |
| Blood triglycerides increased | Investigations | — | — |
| White blood cell count decreased | Investigations | — | — |
| Constipation | Gastrointestinal disorders | — | — |
| Vomiting | Gastrointestinal disorders | — | — |
| Blood bilirubin increased | Investigations | — | — |
| Platelet count increased | Investigations | — | — |
| Cough | Respiratory, thoracic and mediastinal disorders | — | — |
| Asthenia | General disorders | — | — |
| Fatigue | General disorders | — | — |
| Blood thyroid stimulating hormone decreased | Investigations | — | — |
| Neutrophil percentage increased | Investigations | — | — |
| Blood glucose increased | Investigations | — | — |
| White blood cells urine positive | Investigations | — | — |
| Bilirubin conjugated increased | Investigations | — | — |
| Blood sodium decreased | Investigations | — | — |
| Tri-iodothyronine free decreased | Investigations | — | — |
| Anaemia | Blood and lymphatic system disorders | — | — |
| Supraventricular tachycardia | Cardiac disorders | — | — |
| Gastrointestinal disorder | Gastrointestinal disorders | — | — |
| Electrocardiogram T wave abnormal | Investigations | — | — |
| Neutrophil count decreased | Investigations | — | — |
| Thyroxine free increased | Investigations | — | — |
| Pain in extremity | Musculoskeletal and connective tissue disorders | — | — |
Most-reported serious reactions: Malignant neoplasm progression, Abdominal pain, Diarrhoea, Rash, Anaemia, Bone marrow failure, Hypophysitis, Hypopituitarism.
Data from ClinicalTrials.gov NCT02545075 adverse events section.
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.
1 peer-reviewed publication reference this trial (live from Europe PMC):
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