Phase 2 Study of Ipilimumab Plus Dacarbazine in Japanese Patients With Advanced Melanoma
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|ClinicalTrials.gov Identifier: NCT01681212|
Recruitment Status : Completed
First Posted : September 7, 2012
Results First Posted : June 11, 2015
Last Update Posted : June 11, 2015
|Condition or disease||Intervention/treatment||Phase|
|Melanoma||Drug: Ipilimumab Drug: Dacarbazine||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||21 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase 2 Study of Ipilimumab Plus Dacarbazine in Japanese Patients With Previously Untreated Unresectable or Metastatic Melanoma|
|Study Start Date :||October 2012|
|Actual Primary Completion Date :||May 2014|
|Actual Study Completion Date :||May 2014|
Experimental: Ipilimumab, 10 mg/kg + Dacarbazine, 850 mg/m^2
During the Induction Period, participants received ipilimumab, 10 mg/kg, as tolerated by intravenous (IV) infusion as 1 single dose during Weeks 1 (Day 1), 4, 7, and 10 for a total of 4 separate doses. During the Maintenance Phase, participants received ipilimumab, 10 mg/kg, as tolerated by IV infusion every 12 weeks, beginning at Week 24, until disease progression or unacceptable toxicity occurred or the patient withdrew consent. Participants also received dacarbazine, 850 mg/m^2, by IV infusion over 30 to 60 minutes, starting on Week 1 and repeated every 3 weeks until Week 22. Dacarbazine was dosed on the same day as ipilimumab, when applicable, after the ipilimumab dose.
Other Name: BMS-734016
- Percentage of Participants Surviving at 1 Year [ Time Frame: At 1 year from start of study drug ]Survival rate=percentage of participants surviving at 1 year following start of study drug. Every effort was made to collect survival data on all patients, including those withdrawn from treatment for any reason. If the death of a patient was not reported, the patient's last known alive date was recorded. Confidence intervals were computed using the Clopper-Pearson method.
- Number of Participants With Grade 3-4 Immune-related Adverse Events (irAEs) [ Time Frame: First dose to 90 days following last dose of study drug ]irAEs are adverse events of unknown cause, consistent with an immune phenomenon, and considered to be causally related to drug exposure. Six subcategories of irAE are assessed: gastrointestinal, liver, skin, endocrine, neurologic, and other. The irAEs are programmatically determined from a predefined list of MedDRA terms. irAEs will be measured every 3 weeks in induction phase, every 6 weeks in Maintenance Phase to Week 48, and every 12 weeks until Progressive Disease. Grading criteria: Grade 1=Mild, Grade 2=Moderate, Grade 3=Severe, Grade 4=Life-threatening or disabling, Grade 5=Death.
- Number of Patients Who Died and Who Had Serious Adverse Events (SAEs), Treatment-related SAEs, Adverse Events (AEs) Leading to Discontinuation, Related AEs Leading to Discontinuation, Related AEs, Grade 3-4 AEs, and Related Grade 3-4 AEs [ Time Frame: First dose to 90 days following last dose of study drug. All deaths were poststudy, occurring more than 90 days after the last dose of study drug. ]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. Related=having certain, probable, possible, or unknown relationship to study drug. Grade 1=mild; Grade 2=moderate; Grade 3=severe; Grade 4=life-threatening or disabling; Grade 5=death.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01681212
|Fukuoka-shi, Fukuoka, Japan, 8128582|
|Kumamoto-shi, Kumamoto, Japan, 8608556|
|Matsumoto-shi, Nagano, Japan, 3908621|
|Sunto-gun, Shizuoka, Japan, 4118777|
|Chuo-ku, Tokyo, Japan, 1040045|
|Chuo-shi, Yamanashi, Japan, 4093898|
|Study Director:||Bristol-Myers Squibb||Bristol-Myers Squibb|