Clinical Trial VICCMEL12109
A Phase III, Double-Blinded, Placebo-Controlled Study of Vemurafenib versus Vemurafenib Plus GDC-0973 in Previously Untreated BRAFV600 Mutation-Positive Patients with Unresectable Locally Advanced or Metastatic Melanoma
- Protocol No. VICCMEL12109
- Open Date: 05/17/2013
- Staging: Phase III
- Age Group: Adults
- Scope: National
- Objective: To evaluate the efficacy of vemurafenib in combination with GDC-0973, compared with vemurafenib and placebo, in previously untreated BRAFV600 mutation-positive patients with unresectable locally advanced or metastatic melanoma, as measured by prolongation of PFS, as assessed by the study site investigator.
- Disease Sites: Melanoma
- Therapies: Molecular Targeted Agents / Immunotherapy / Biologics
- Drugs: GDC-0973; PLX4032; RO5185426 (Vemurafenib); Vemurafenib
- Participating Institutions: Vanderbilt University
- National Clinical Trial ID: NCT01689519
- Secondary Protocol No: GO28141
Participants are being asked to take part in this study because they have unresectable (tumor cannot be completely removed through surgery) locally advanced and/or metastatic melanoma (a type of skin cancer that has spread) that has not been previously treated. The purpose of this study is to compare the effects, good and/or bad, of cobimetinib (GDC-0973) and vemurafenib with vemurafenib alone on the participants and their melanoma, to find out which is better.
|Ages Eligible for Study:||18 Years and older|
|Genders Eligible for Study:||Both|
|Accepts Healthy Volunteers:||No|
• Patients 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.
• Patients must be naïve to treatment for locally advanced unresectable or metastatic disease (i.e., no prior systemic anti-cancer therapy for advanced disease; stage IIIc and IV). Prior adjuvant immunotherapy (including ipilimumab) is allowed.
• Documentation of BRAFV600 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 >/= 12 weeks.
• Adequate hematologic and end organ function
• History of prior RAF or MEK 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. Patients with a previous malignancy within the past 3 years are excluded except for patients with resected basal cell carcinoma (BCC) or squamous cell carcinoma (SCC) 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 ophthalmologic examination that is considered a risk factor for neurosensory retinal detachment, retinal vein occlusion (RVO), or neovascular macular degeneration.
• Uncontrolled glaucoma with intra-ocular pressures
• Serum cholesterol >/= Grade 2
• Hypertriglyceridemia >/= Grade 2
• Hyperglycemia (fasting) >/= Grade 2
• History of clinically significant cardiac dysfunction
• Patients with active CNS lesions (including carcinomatous meningitis) are excluded. However, patients 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.