A Phase 3 interventional study of Ipilimumab and Dacarbazine in Melanoma, sponsored by Bristol-Myers Squibb. Completed at 8 sites in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-05-19.
Sponsored by Bristol-Myers Squibb · Phase 3, Interventional, and Treatment
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.
3,006 studies on the registry are indexed under Melanoma; 519 are open to participants now.
This study's enrollment of 182 is above the median of 38 across 2,350 interventional studies indexed under Melanoma.
Browse Melanoma studies →Bristol-Myers Squibb is the lead sponsor of 1,538 studies on the registry; 116 are open to participants now.
Of its 429 completed or terminated interventional studies of FDA-regulated products, 223 (52%) have results posted.
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Inclusion Criteria:
Exclusion Criteria:
Intravenously (IV) 3 mg/kg every 3 weeks (at week 1,4,7,10) and thereafter (q3w/4 doses) at the time of progression
Drug: Ipilimumab
IV solution 250 mg/m2 (Day 1-5, every 3weeks/at week 1, 4, 7, 10,13,16,19,22)
Drug: Dacarbazine
Also known as: MDX-010
Also known as: DTIC
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.
Time frame: 24 months
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.
Time frame: Approximately 43 months
Overall Survival (OS)
OS is defined for each subject as the time between randomization date and the date of death (of any cause).
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: 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)."
Time frame: Approximately 43 months
| Milestone | Ipilimumab (3 mg/kg) | Dacarbazine (250 mg/m2) |
|---|---|---|
| Started | 122 | 60 |
| Completed | 122 | 53 |
| Not completed | 0 | 7 |
| Withdrew: Lost to follow-up | 0 | 1 |
| Withdrew: Withdrawal by subject | 0 | 6 |
| Milestone | Ipilimumab (3 mg/kg) | Dacarbazine (250 mg/m2) |
|---|---|---|
| Started | 122 | 53 |
| Completed | 0 | 0 |
| Not completed | 122 | 53 |
| Withdrew: Disease progression | 71 | 32 |
| Withdrew: Participant dicontinued study treatment | 7 | 9 |
| Withdrew: Withdrawal by subject | 1 | 0 |
| Withdrew: Adverse event not related to study drug | 1 | 0 |
| Withdrew: Death | 1 | 0 |
| Withdrew: Participant drug toxicity | 1 | 0 |
| Withdrew: Completed treatment | 40 | 12 |
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.
| Percentage of Participants | Ipilimumab (3 mg/kg) | Dacarbazine (250 mg/m2) |
|---|---|---|
| Two-Years Survival Rate | 33.98 (28.36 to 39.67) | 34.09 (25.72 to 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.
| Percentage of Participants | Ipilimumab (3 mg/kg) | Dacarbazine (250 mg/m2) |
|---|---|---|
| One-Year Survival Rate | 61.68 (55.71 to 67.09) | 64.11 (54.99 to 71.87) |
OS is defined for each subject as the time between randomization date and the date of death (of any cause).
| Months | Ipilimumab (3 mg/kg) | Dacarbazine (250 mg/m2) |
|---|---|---|
| Overall Survival (OS) | 15.08 (12.91 to 16.10) | 14.55 (13.37 to 19.19) |
PFS is defined for each subject as the time between randomization date and the date of progression or death, whichever occurs first.
| Months | Ipilimumab (3 mg/kg) | Dacarbazine (250 mg/m2) |
|---|---|---|
| Progression Free Survival ( PFS) | 2.60 (2.60 to 2.63) | 1.84 (1.41 to 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.
| Percentage of participants | Ipilimumab (3 mg/kg) | Dacarbazine (250 mg/m2) |
|---|---|---|
| Disease Control Rate ( DCR ) | 32 (26.4 to 38.0) | 31.7 (23.7 to 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.
| Percentage of participants | Ipilimumab (3 mg/kg) | Dacarbazine (250 mg/m2) |
|---|---|---|
| Best Overall Response Rate ( BORR ) | 8.2 (5.2 to 12.3) | 8.3 (4.1 to 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).
| Months | Ipilimumab (3 mg/kg) | Dacarbazine (250 mg/m2) |
|---|---|---|
| Duration of Response ( DoR) | 8.99 (4.76 to 29.01) | 7.98 (1.45 to 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)."
| Months | Ipilimumab (3 mg/kg) | Dacarbazine (250 mg/m2) |
|---|---|---|
| Duration of Stable Disease ( DoSD ) | 6.83 (5.29 to 7.62) | 9.40 (5.26 to 16.30) |
Collected over Approximately 43 months. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Ipilimumab | 93/122 (76.2%) | 34/122 (27.9%) | 118/122 (96.7%) |
| Dacarbazine | 39/53 (73.6%) | 12/53 (22.6%) | 48/53 (90.6%) |
| Event | Ipilimumab | Dacarbazine |
|---|---|---|
| Malignant neoplasm progressionNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 16/122 | 7/53 |
| AnaemiaBlood and lymphatic system disorders | 1/122 | 1/53 |
| Bone marrow failureBlood and lymphatic system disorders | 0/122 | 1/53 |
| HaematemesisGastrointestinal disorders | 0/122 | 1/53 |
| Skin infectionInfections and infestations | 0/122 | 1/53 |
| OverdoseInjury, poisoning and procedural complications | 0/122 | 1/53 |
| Electrolyte imbalanceMetabolism and nutrition disorders | 0/122 | 1/53 |
| HypoproteinaemiaMetabolism and nutrition disorders | 0/122 | 1/53 |
| Pulmonary embolismRespiratory, thoracic and mediastinal disorders | 0/122 | 1/53 |
| RashSkin and subcutaneous tissue disorders | 2/122 | 1/53 |
| Event | Ipilimumab | Dacarbazine |
|---|---|---|
| NauseaGastrointestinal disorders | 18/122 | 22/53 |
| Alanine aminotransferase increasedInvestigations | 31/122 | 19/53 |
| Aspartate aminotransferase increasedInvestigations | 22/122 | 17/53 |
| Decreased appetiteMetabolism and nutrition disorders | 27/122 | 17/53 |
| White blood cell count decreasedInvestigations | 7/122 | 15/53 |
| RashSkin and subcutaneous tissue disorders | 33/122 | 3/53 |
| ConstipationGastrointestinal disorders | 14/122 | 14/53 |
| Blood lactate dehydrogenase increasedInvestigations | 28/122 | 3/53 |
| Blood thyroid stimulating hormone increasedInvestigations | 27/122 | 4/53 |
| PruritusSkin and subcutaneous tissue disorders | 27/122 | 2/53 |
All randomized participants
| Age, Continuous(years) | Ipilimumab (3 mg/kg) | Dacarbazine (250 mg/m2) | Total |
|---|---|---|---|
| Mean | 53.6 ± 13.69 | 54.3 ± 13.39 | 53.8 ± 13.56 |
| Sex: Female, Male(Participants) | Ipilimumab (3 mg/kg) | Dacarbazine (250 mg/m2) | Total |
|---|---|---|---|
| Female | 53 | 26 | 79 |
| Male | 69 | 34 | 103 |
| Ethnicity (NIH/OMB)(Participants) | Ipilimumab (3 mg/kg) | Dacarbazine (250 mg/m2) | Total |
|---|---|---|---|
| Hispanic or Latino | 0 | 0 | 0 |
| Not Hispanic or Latino | 0 | 0 | 0 |
| Unknown or Not Reported | 122 | 60 | 182 |
| Race (NIH/OMB)(Participants) | Ipilimumab (3 mg/kg) | Dacarbazine (250 mg/m2) | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 122 | 60 | 182 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 0 | 0 | 0 |
| White | 0 | 0 | 0 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
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