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

  • Interventional
  • Not Recruiting
  • NCT00324155
Eligibility Details Visit Clinicaltrials.gov

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

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

For the extension phase:

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

Gender
All

Age Group
18 Years and up

Accepting Healthy Volunteers?
No

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

At a Glance

National Government IDNCT00324155

IRB#15313B

Lead SponsorBristol-Myers Squibb

Lead PhysicianThomas F. Gajewski

Collaborator(s)N/A

EligibilityAll
18 Years and up
Not Recruiting