Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Bristol-Myers Squibb
Age
20–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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)
You may not be if
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
Clareo Health | Phase 2 Study of Ipilimumab Plus Dacarbazine in Japanese Patients With Advanced Melanoma
