Phase 2
Completed N=21
Phase 2 Study of Ipilimumab Plus Dacarbazine in Japanese Patients With Advanced Melanoma
Source: ClinicalTrials.gov NCT01681212 ↗Enrolled (actual)
21
Serious AEs
93.3%
Results posted
Jun 2015
Primary outcomePrimary: Percentage of Participants Surviving at 1 Year — 66.7 Percentage of participants
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Surviving at 1 Year |
66.7 | — |
| SECONDARY Number of Participants With Grade 3-4 Immune-related Adverse Events (irAEs) |
11; 10; 12; 6; 3; 0 | — |
| SECONDARY Number of Patients Who Died and Who Had Serious Adverse Events (SAEs), Treatment-related SAEs, Adverse Events (AEs) Leading to Discontinuation, Related AEs Leading to Discontinuation, Related AEs, Grade 3-4 AEs, and Related Grade 3-4 AEs |
5; 14; 11; 9; 9; 11 | — |
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT01681212). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.