Study of BMS-936558 vs. Dacarbazine in Untreated, Unresectable or Metastatic Melanoma
| Status: | Recruiting |
|---|---|
| Conditions: | Skin Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 3/30/2013 |
| Start Date: | January 2013 |
| End Date: | June 2020 |
| Contact: | For participation information at a USA site use a phone number below. For site information outside the USA please email: |
| Email: | Clinical.Trials@bms.com |
A Phase 3, Randomized, Double-Blind Study of BMS-936558 vs Dacarbazine in Subjects With Previously Untreated, Unresectable or Metastatic Melanoma
The purpose of this study is to compare the clinical benefit, as measured by duration of
overall survival, of BMS-936558 vs. Dacarbazine in subjects with previously untreated,
unresectable or metastatic melanoma
Inclusion Criteria:
- Men and women ≥ 18 years of age
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
- Untreated, histologically confirmed unresectable Stage III or Stage IV melanoma, as
per AJCC staging system
- Measurable disease as per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1
- Recently acquired (within 90 days prior to randomization) tumor tissue from an
unresectable or metastatic site of disease must be provided for biomarker analyses
- Known BRAF wild-type as per regionally acceptable V600 mutational status testing.
BRAF mutant subjects and those with indeterminate or unknown BRAF status are not
permitted to enroll
Exclusion Criteria:
- Active brain metastases or leptomeningeal metastases
- Ocular melanoma
- Any active, known or suspected autoimmune disease
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