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A Randomized, Double-Blind, Multicenter Study Comparing MDX-010 Monotherapy, MDX-010 in Combination With a Melanoma Peptide Vaccine, and Melanoma Vaccine Monotherapy in HLA-A2*0201-Positive Patients With Previously Treated Unresectable Stage III or IV Melanoma

Phase 3
18 Years
Not Enrolling
Melanoma, Metastases

Thank you

Trial Information

A Randomized, Double-Blind, Multicenter Study Comparing MDX-010 Monotherapy, MDX-010 in Combination With a Melanoma Peptide Vaccine, and Melanoma Vaccine Monotherapy in HLA-A2*0201-Positive Patients With Previously Treated Unresectable Stage III or IV Melanoma

Melanoma accounts for approximately 5% of all skin cancers in the United States, but it
accounts for about 75% of all skin cancer deaths. In 2004, the expected prevalence of
melanoma is 627,252, with about 119,178 of these cases being Stage III or IV (metastatic
melanoma). First line treatments for metastatic melanoma, usually IL-2, dacarbazine and/or
temozolomide, are associated with significant toxicities. MDX-010 (anti-CTLA4) antibodies
are designed to keep the immune system running by blocking CTLA-4 from down-regulating T
cell activation. MDX-1379 is made up of two peptides that are pieces of a bigger melanoma
protein (gp100). These peptides bind to HLA-A2 which is then recognized by T cells.

Inclusion Criteria:

- Diagnosed with malignant melanoma

- Measurable unresectable Stage III or IV melanoma

- HLA-A*0201 positive

- Previous treatment with & failure/relapse/inability to tolerate IL-2, dacarbazine
and/or temozolomide

- At least 4 weeks since prior treatment

- Negative pregnancy

- Life expectancy greater than 4 months

- Eastern Cooperative Oncology Group (ECOG) performance of 0 or 1

- Required lab values

- Human Immunodeficiency Virus (HIV), Hepatitis B Virus (HBV), Hepatitis C Virus (HCV)

Exclusion Criteria:

- Prior malignancies which the patient has not been disease free for over 5 years,
except treated and cured basal or squamous cell skin cancer, superficial bladder
cancer, carcinoma in situ of the cervix, or any other cancer

- Ocular melanoma

- Active, untreated central nervous system (CNS) metastasis

- Prior treatment with MDX-010 (anti-CTLA4) antibody

- Prior treatment with any cancer therapeutic vaccine

- Active autoimmune disease or history of autoimmune disease

- Pregnancy or nursing

- Hypersensitivity to Incomplete Freund's Adjuvant (IFA) (Montanide ISA-51)

- Underlying medical conditions deemed hazardous if treated with study drug

- Concomitant therapy with anti-melanoma drugs, chemotherapies, other investigational
therapies, chronic use of systemic corticosteroids

- Unable to provide informed consent

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Outcome Measure:

Overall Survival (OS) (Time-to-Death) Difference Between MDX-010 in Combination With gp 100 Melanoma Peptide Vaccine Versus gp 100 Melanoma Peptide Vaccine Alone

Outcome Description:

OS was defined as the time from randomization until death from any cause. If a participant did not expire, the subject was censored at the time of last contact (last known alive date). 95% confidence intervals (CI) for median were computed using Brookmeyer and Crowley method.

Outcome Time Frame:

From randomization until the end of the study, which was defined as the time at which 481 deaths were observed (264 weeks)

Safety Issue:


Principal Investigator

Bristol-Myers Squibb

Investigator Role:

Study Director

Investigator Affiliation:

Bristol-Myers Squibb


United States: Food and Drug Administration

Study ID:




Start Date:

September 2004

Completion Date:

October 2009

Related Keywords:

  • Melanoma
  • Metastases
  • melanoma
  • metastatic melanoma
  • skin cancer
  • Melanoma
  • Neoplasm Metastasis



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