Phase 2 Study of Ipilimumab Plus Dacarbazine in Japanese Patients With Advanced Melanoma

Phase 2 Study of Ipilimumab Plus Dacarbazine in Japanese Patients With Previously Untreated Unresectable or Metastatic Melanoma

The purpose of this study is to determine the survival rate after 1 year of treatment with ipilimumab plus dacarbazine in patients with previously untreated Stage III (unresectable) or Stage IV melanoma.

Key inclusion criteria:

• Japanese patients with histologic diagnosis of malignant melanoma

• Previously untreated Stage III with N3 (unresectable) or Stage IV melanoma

• Prior adjuvant melanoma therapy permitted

• Eastern Cooperative Oncology Group performance status of 0 or 1

• Life expectancy of at least 16 weeks in this study

• Adequate bone marrow and renal and hepatic function, specifically:

  • white blood cell count ≥2500/uL, absolute neutrophil count ≥1000/uL, platelet count ≥75,000/uL, hemoglobin level ≥9.0 g/dL, creatinine level ≤2.5*upper limit of normal (ULN), aspartate transaminase/alanine transaminase level <2.5*ULN for patients without liver metastasis and <5*ULN for patients with liver metastasis, total bilirubin level <1.5*ULN (for those with Gilbert's Syndrome, lower than 3.0 mg/dL)

Key exclusion criteria:

• Evidence of brain metastases on brain imaging
• Active brain metastases with symptoms or requiring corticosteroid treatment; patients with any other malignancy from which they have been disease-free for fewer than 5 years, with the exception of adequately treated and cured basal or squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of the cervix
• Primary ocular or mucosal melanoma
• History of or current active autoimmune disease
• History or concurrent disease of gastrointestinal perforations
• HIV infection; active Hepatitis B or C or human T-lymphotropic virus type1 infection, based on testing performed during the screening period of this study
• Prior or concomitant therapy with any anticancer agent for melanoma, or other investigational anticancer therapies
• Prior adjuvant therapy <4 weeks prior to the start of study drug administration
• Concomitant therapy with immunosuppressive agents, surgery, or radiotherapy
• Prior treatment with CTLA-4 inhibitors/agonists or other experimental immunotherapy drugs
• Treatment with other investigational products within 4 weeks prior to initial treatment of study drug