Randomized Phase II Trial of Vemurafenib (PLX4032/RG7204) With or Without Bevacizumab in Patients With Stage IV BRAFV600 Mutant Melanoma
Inclusion Criteria:
- Metastatic or unresectable stage IIIc & clearly progressive melanoma
- Melanoma must be documented to contain a BRAFV600 mutation
- Measurable disease
- No more than 2 prior systemic treatment regimens for distant metastatic disease. The
following prior therapy is permitted in either the adjuvant or metastatic setting:
immunotherapy consisting of interferon, interleukin-2, GM-CSF, ipilimumab, anti-PD1
or other experimental agent; and cytotoxic chemotherapy consisting of dacarbazine,
temozolomide, carboplatin +/- paclitaxel
- ECOG performance status of 0, 1, or 2
Exclusion Criteria:
- Pregnant or nursing mothers
- Treatment with a prior VEGF pathway, BRAF, or MEK inhibitor(s)
- Receipt of any other investigational agents during the period on study or the four
weeks prior to entry
- Clinical evidence of active brain metastasis
- Concurrent uncontrolled malignancies that require therapy or other intervention
- Major surgical procedure, open biopsy (excluding skin cancer resection), or
significant traumatic injury within 28 days prior to Day 1 or anticipation of need
for major surgical procedure during the course of the study
- Core biopsy, skin cancer resection, or other minor surgical procedure within 7 days
prior to Day 1 of the protocol
- Serious intercurrent illness
- HIV-positive patients receiving combination anti-retroviral therapy