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

Bristol-Myers Squibb (BMS)

Status and phase: Completed; Phase 2

Conditions: Melanoma

Treatments: Drug: Ipilimumab; Drug: Dacarbazine

Study type: Interventional

Funder types: Industry

Identifiers

NCT01681212

CA184-202

Details and patient eligibility

About

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.

Enrollment: 21 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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21 participants in 1 patient group

Ipilimumab, 10 mg/kg + Dacarbazine, 850 mg/m^2

Experimental group

Description:

During the Induction Period, participants received ipilimumab, 10 mg/kg, as tolerated by intravenous (IV) infusion as 1 single dose during Weeks 1 (Day 1), 4, 7, and 10 for a total of 4 separate doses. During the Maintenance Phase, participants received ipilimumab, 10 mg/kg, as tolerated by IV infusion every 12 weeks, beginning at Week 24, until disease progression or unacceptable toxicity occurred or the patient withdrew consent. Participants also received dacarbazine, 850 mg/m\^2, by IV infusion over 30 to 60 minutes, starting on Week 1 and repeated every 3 weeks until Week 22. Dacarbazine was dosed on the same day as ipilimumab, when applicable, after the ipilimumab dose.

Treatment:

Drug: Dacarbazine

Drug: Ipilimumab