GDC-0973 plus vemurafenib versus vemurafenib alone in patients with unresectable stage IIIC or metastatic melanoma harboring BRAF V600 mutations.
- Conditions
- BRAFV600-mutation positive patients with unresectable locally advanced or metastatic melanomaMedDRA version: 14.1 Level: PT Classification code 10025650 Term: Malignant melanoma System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 14.1 Level: PT Classification code 10027480 Term: Metastatic malignant melanoma System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2012-003008-11-NO
- Lead Sponsor
- F. Hoffman-La Roche Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 495
•= 18 years of age
•Stage IIIc or Stage IV melanoma harboring BRAF V600 mutation
•BRAF V600 mutation must be confirmed by cobas 4800 BRAF V600 mutation test
•Measurable disease according to RECIST 1.1
•Women of childbearing potential with negative serum pregnancy test prior to randomization
•Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
•Adequate baseline organ function
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 380
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 120
•Any prior use of a BRAF or MEK inhibitor
•Prior systemic anti-cancer treatment in the advanced or metastatic setting; prior systemic treatment in the adjuvant setting is allowed
•History of another malignancy except subjects who have been disease free for 3 years or have completely resected non-melanoma skin cancer.
•Patients with active CNS lesions (including carcinomatous meningitis) are excluded. However, patients are eligible if:
a)all known CNS lesions have been treated with stereotactic therapy or surgery, AND
b)no evidence of clinical and radiographic disease progression in the CNS for = 3 weeks after radiotherapy or surgery.
Whole brain radiotherapy is not allowed with the exception of patients who have had definitive resection or stereotactic therapy of all radiologically detectable parenchymal brain lesions.
•Evidence of cardiovascular risk (LVEF < LLN; QTc = 450 msec; blood pressure =140/90 mmHg which cannot be controlled by anti-hypertensive therapy)
•History, risk factors for or evidence of neurosensory retinal detachment, retinal vein occlusion or neovascular macular degeneration.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <br> Main 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<br> progression-free survival (PFS), as assessed by the study site investigator.<br> ;<br> Secondary 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 overall survival (OS),<br> objective response rate (ORR), and duration of response (DOR).<br> ;Primary end point(s): Progression Free Survival ;Timepoint(s) of evaluation of this end point: approx. 16 months
- Secondary Outcome Measures
Name Time Method <br> Secondary end point(s): 1. Overall Survival <br> <br> 2. Overall Response Rate<br> <br> 3. Duration of Response<br> ;<br> Timepoint(s) of evaluation of this end point: 1. approx. 36 months <br> <br> 2. Time Frame: approx. 16 months <br> <br> 3. Duration of Response<br>