A Study Comparing Vemurafenib Versus Vemurafenib Plus Cobimetinib in Participants With Metastatic Melanoma

Not Recruiting

Trial ID: NCT01689519

Purpose

To evaluate the efficacy of vemurafenib in combination with cobimetinib (GDC-0973), compared with vemurafenib and placebo, in previously untreated BRAF V600 mutation-positive patients with unresectable locally advanced or metastatic melanoma, as measured by progression-free survival (PFS), assessed by the study site investigator.

Official Title

A Phase III, Double-Blind, Placebo-Controlled Study of Vemurafenib Versus Vemurafenib Plus GDC-0973 in Previously Untreated BRAF^600-Mutation Positive Patients With Unresectable Locally Advanced or Metastatic Melanoma

Eligibility


Inclusion Criteria:

   - Participants with histologically confirmed melanoma, either unresectable stage IIIc or
   stage IV metastatic melanoma, as defined by the American Joint Committee on Cancer 7th
   edition. Unresectability of stage IIIc disease must have confirmation from a surgical
   oncologist

   - Participants must be naïve to treatment for locally advanced unresectable or
   metastatic disease (ie, no prior systemic anti-cancer therapy for advanced disease;
   stage IIIc and IV). Prior adjuvant immunotherapy (including ipilimumab) is allowed

   - Documentation of BRAF V600 mutation-positive status in melanoma tumor tissue (archival
   or newly obtained tumor samples) using the cobas 4800 BRAF V600 mutation test

   - Measurable disease per RECIST v1.1

   - Eastern Clinical Oncology Group performance status of 0 or 1

   - Consent to provide archival for biomarker analyses

   - Consent to undergo tumor biopsies for biomarker analyses

   - Life expectancy greater than or equal to (≥) 12 weeks

   - Adequate hematologic and end organ function

Exclusion Criteria:

   - History of prior rapidly accelerated fibrosarcoma or mitogen-activated protein kinase
   pathway inhibitor treatment

   - Palliative radiotherapy within 14 days prior to the first dose of study treatment

   - Major surgery or traumatic injury within 14 days prior to first dose of study
   treatment

   - Active malignancy other than melanoma that could potentially interfere with the
   interpretation of efficacy measures. Participants with a previous malignancy within
   the past 3 years are excluded except for participants with resected basal cell
   carcinoma or squamous cell carcinoma of the skin, melanoma in-situ, carcinoma in-situ
   of the cervix, and carcinoma in-situ of the breast

   - History of or evidence of retinal pathology on ophthalmological examination that is
   considered a risk factor for neurosensory retinal detachment, retinal vein occlusion,
   or neovascular macular degeneration

   - Uncontrolled glaucoma with intraocular pressure

   - Serum cholesterol ≥ Grade 2

   - Hypertriglyceridemia ≥ Grade 2

   - Hyperglycemia (fasting) ≥ Grade 2

   - History of clinically significant cardiac dysfunction

   - Participants with active central nervous system (CNS) lesions (including carcinomatous
   meningitis) are excluded. However, participants are eligible if:

      1. All known CNS lesions have been treated with stereotactic therapy or surgery, AND

      2. There has been no evidence of clinical and radiographic disease progression in
      the CNS for ≥ 3 weeks after radiotherapy or surgery

   - Current severe, uncontrolled systemic disease

   - History of malabsorption or other condition that would interfere with absorption of
   study drugs

   - Pregnant, lactating, or breast feeding women

Intervention(s):

drug: vemurafenib

drug: Placebo

drug: Cobimetinib

Not Recruiting

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Jennifer Vargas
650-723-0371

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