Dacarbazine and Ipilimumab vs. Dacarbazine With Placebo in Untreated Unresectable Stage III or IV Melanoma | NCT00324155 | Trialant

CompletedInterventionalPhase 3Updated Nov 3, 2014

Dacarbazine and Ipilimumab vs. Dacarbazine With Placebo in Untreated Unresectable Stage III or IV Melanoma

A Multi-center, Randomized, Double-Blind, Two-Arm, Phase III Study in Patients With Untreated Stage III (Unresectable) or IV Melanoma Receiving Dacarbazine Plus 10 mg/kg Ipilimumab (MDX-010) vs. Dacarbazine With Placebo

Overview

Key facts that identify this study and show where it stands today.

ClinicalTrials.gov ID: NCT00324155
Lead Sponsor: Bristol-Myers SquibbINDUSTRY
Overall Status: Completed
Study Type: Interventional
Phase: Phase 3
Enrollment: 681Actual
Last Update Posted: Nov 3, 2014Estimated
Start Date: Aug 2006
Primary Completion Date: Jan 2011Actual
Completion Date: Oct 2013Actual

Description

What the study is about and why it is being run, in the researchers' own words.

Official Title: A Multi-center, Randomized, Double-Blind, Two-Arm, Phase III Study in Patients With Untreated Stage III (Unresectable) or IV Melanoma Receiving Dacarbazine Plus 10 mg/kg Ipilimumab (MDX-010) vs. Dacarbazine With Placebo
Brief Summary: The purpose of this clinical research study is to examine the safety and effectiveness (how well the drug works) of two different treatments for patients with melanoma. One treatment is an investigational compound (a drug that is not currently approved by the United States Food and Drug Administration [FDA]), know as Ipilimumab (also known as MDX-010 or BMS-734016) together with an approved chemotherapy drug called Dacarbazine
Detailed Description: For the extension phase:

Allocation: single arm study; Masking: open label; Intervention Model: Single Group

Conditions

The medical conditions and diseases this study investigates.

Melanoma

Interventions

The treatments and procedures being evaluated in this study.

Ipilimumab
Placebo
Dacarbazine

Participation

Who can join this study and the criteria used to decide.

Ages Eligible for Study: Adult (18-64)Older Adult (65+)
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Eligibility Criteria: Inclusion Criteria:

Informed Consent

Measurable Disease

Eastern Cooperative Oncology Group (ECOG) 0 or 1

Lab / imaging requirements

Neg for Human Immunodeficiency Virus (HIV), Hepatitis B (HepB), C

Men and Women > 18 years (16 were allowable)

Prior therapy restriction (adjuvant only)

Exclusion:

Pregnant / nursing

Inadequate contraception

Brain metastasis

Primary ocular or mucosal melanoma

Design

How the study is designed and how its participant groups are organized.

Primary Purpose: Treatment
Allocation: Randomized
Interventional Model: Parallel Assignment
Masking: Double

Contacts

The people to reach with questions about this study or how to join it.

No central contacts

There are no central contacts for this study.

Locations

Where the study is run and whether each site is currently recruiting.

Pacific Cancer Medical Center

Anaheim, California 92801, United States

Collaborators

The organizations and people involved in this study.

Lead Sponsor: Bristol-Myers SquibbINDUSTRY
Collaborators

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