West Cancer Center

MOLECULARLY TARGETED: BRAF mut: Metastatic; >/= 2nd line; \"My Pathway- BRAF\"

My Pathway: An open-label Phase IIA study evaluating trastuzumab/pertuzumab, erlotinib, vemurafenib/cobimetinib, vismodegib, alectinib, and atezolizumab in patients who have advanced solid tumors with mutations or gene expression abnormalities predictive of response to one of these agents

Title

Genentech ML28897 BRAF

Study Title

Site Link

NCT02091141

Malignancy

Lung, Genital tract (bladder, kidney, ureter), ovarian (ovary), biliary tract (bile duct), endometrial (uterus), prostate

Stage

Stage 4

Disease Setting

Metastatic/Palliative

Line Of Therapy

> or equal to 2nd line

Investigational Agent

Vemurafenib and Cobimetinib

Drug Class

BRAF inhibitor + MEK inhibitor

VanderWalde

Sponsor

Genentech, Inc.

Phase

Phase 2

Status

Closed to Accrual

Key Eligibility Criteria

http://www.clinicaltrials.gov/ct2/show/NCT02091141

Key Eligibility Criteria Details

Metastatic solid tumor_
No known RAS mutation
No melanoma, papillary thyroid, colorectal, or hematologic malignancies2nd line or greater
ECOG PS 0-2
No prior treatment with any BRAF inhibitor (sorafenib is allowed)
No prior treatment with a MEK inhibitor
No active or untreated CNS metastastasis

Objective

Primary- ORR; Secondary- DCR, PFS, 1-year OS

Assessment Frequency

Assessment Frequency 2

Assessment Frequency Link

Path

BRAF activating mutation

Dosing Frequency

Vemurafenib 960mg PO bid

Cobimetinib 60 mg PO qday 21 days on, 7 days off

Control Agents

None

Study Protocol

Randomized