A Comparative Study in Chinese Subjects With Chemotherapy Naïve Stage IV Melanoma Receiving Ipilimumab (3 mg/kg) vs. Dacarbazine

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

182 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-10-31

Study Completion Date

2019-04-19

Brief Summary

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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.

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Detailed Description

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Conditions

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Melanoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Ipilimumab

Intravenously (IV) 3 mg/kg every 3 weeks (at week 1,4,7,10) and thereafter (q3w/4 doses) at the time of progression

Group Type EXPERIMENTAL

Ipilimumab

Intervention Type DRUG

Dacarbazine

IV solution 250 mg/m2 (Day 1-5, every 3weeks/at week 1, 4, 7, 10,13,16,19,22)

Group Type EXPERIMENTAL

Dacarbazine

Intervention Type DRUG

Interventions

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Ipilimumab

Intervention Type DRUG

Dacarbazine

Intervention Type DRUG

Other Intervention Names

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MDX-010 DTIC

Eligibility Criteria

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Inclusion Criteria

* Chinese males and females ≥ 18 years of age
* Histologic diagnosis of malignant melanoma
* Chemotherapy naive Stage IV melanoma (AJCC 2010)
* Life expectancy of ≥ 16 weeks
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

Exclusion Criteria

* Evidence of brain metastases on brain imaging
* Primary ocular or mucosal melanoma
* Any other malignancy from which the patient has been disease-free for less than 5 years
* BRAF status cannot be determined by Screening test
* Human Immunodeficiency Virus (HIV) positive or hepatitis B surface antigen (HBsAg) positive, or active Hepatitis C infection

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No