MDX-010 Antibody, MDX-1379 Melanoma Vaccine, or MDX-010/MDX-1379 Combination Treatment for Patients With Unresectable or Metastatic Melanoma
Condition: Melanoma; Metastases
MeSH terms: Melanoma
Intervention: MDX-010 (anti-CTLA4) monoclonal antibody; MDX-1379 (gp100) Melanoma Peptide Vaccine
Intervention description: 3mg/kg (intravenous [iv] infusion over 90 minutes), every 3 weeks for 4 doses; 2mL (2 subcutaneous injections of 2 mL each, 1 to each thigh), every 3 weeks for 4 doses.
Intervention MeSH terms: Ipilimumab; Vaccines; Antibodies; Antibodies, Monoclonal
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 1783.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: melanoma; metastatic melanoma; skin cancer

Summary:

      The purpose of this study is to determine the safety and efficacy of MDX-010 (ipilimumab,
      BMS-734016) (anti-CTLA4) in combination with MDX-1379 (gp100, BMS-734019) in patients with
      previously treated, unresectable Stage III or IV melanoma. Survival time will be evaluated,
      as well as patient responses and time to disease progression. Eligible patients are those who
      in response to a single regimen containing interleukin-2 (IL-2), dacarbazine, and/or
      temozolomide, have 1) relapsed following an objective response (partial response/complete
      response [PR/CR]); 2) failed to demonstrate an objective response (PR/CR); or 3) could not
      tolerate such a regimen due to unacceptable toxicity. Patients will be randomized into one of
      three groups, and will receive one of the following treatments: MDX-010 alone, MDX-1379
      alone, or MDX-010 in combination with MDX-1379.
    

Eligibility criteria:

        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)
             negative

        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