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

Bristol-Myers Squibb (BMS)

Status and phase: Completed; Phase 3

Conditions: Melanoma

Treatments: Drug: Dacarbazine; Drug: Placebo; Drug: Ipilimumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT00324155

CA184-024

Details and patient eligibility

About

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

Full description

For the extension phase:

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

Enrollment: 681 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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681 participants in 2 patient groups

Arm A: Ipilimumab and Dacarbazine

Experimental group

Description:

In Maintenance phase: Ipilimumab will be continued. Dacarbazine was given up to Week 22 and is not given in the Maintenance phase

Treatment:

Drug: Ipilimumab

Drug: Dacarbazine

Arm B: Placebo and Dacarbazine

Active Comparator group

Treatment:

Drug: Dacarbazine

Drug: Placebo