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Randomized Phase II Trial of Vemurafenib (PLX4032/RG7204) With or Without Bevacizumab in Patients With Stage IV BRAFV600 Mutant Melanoma

Phase 2
18 Years
Not Enrolling
Melanoma, Metastatic Melanoma

Thank you

Trial Information

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

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Median progression free survival

Outcome Time Frame:

Time between randomization and disease progression (~6-11 months)

Safety Issue:


Principal Investigator

Michael B Atkins, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Beth Israel Deaconess Medical Center


United States: Institutional Review Board

Study ID:




Start Date:

June 2012

Completion Date:

March 2015

Related Keywords:

  • Melanoma
  • Metastatic Melanoma
  • Metastatic melanoma
  • BRAF-mutant
  • Stage IV melanoma
  • Vemurafenib
  • Bevacizumab
  • Melanoma



Dana-Farber Cancer Institute Boston, Massachusetts  02115
Beth Israel Deaconess Medical Center (BIDMC) Boston, Massachusetts  02215