A Study of Vemurafenib and GDC-0973 (Cobimetinib) in Participants With BRAFV600E Mutation-Positive Metastatic Melanoma

Status:	Completed
Conditions:	Skin Cancer
Therapuetic Areas:	Oncology
Healthy:	No
Age Range:	18 - Any
Updated:	12/1/2018
Start Date:	February 17, 2011
End Date:	December 12, 2017

A Phase IB, Open-Label, Dose-Escalation Study Evaluating the Safety, Tolerability and Pharmacokinetics of Vemurafenib in Combination With GDC-0973 (Cobimetinib) When Administered in BRAFV600E Mutation-Positive Patients Previously Treated (But Without Prior Exposure to BRAF or MEK Inhibitor Therapy) or Previously Untreated for Locally Advanced/Unresectable or Metastatic Melanoma or Those Who Have Progressed After Treatment With Vemurafenib

This open-label, dose-escalation study of vemurafenib in combination with cobimetinib will
evaluate the safety, tolerability and pharmacokinetics in participants with BRAFV600
mutation-positive metastatic melanoma. Participants with previously untreated, BRAFV600E
mutation-positive, locally advanced/unresectable or metastatic melanoma or those who have
progressed on vemurafenib monotherapy immediately prior to enrolling in this trial are
eligible. Participants will be assigned to different cohorts with escalating oral doses of
vemurafenib and cobimetinib. This study consists of 2 stages, Stage 1 (Dose Escalation Stage
[DES] and Cohort Expansion Stage [CES]) and the anticipated time on study treatment is until
disease progression, unacceptable toxicity or any other discontinuation criterion is met.

Inclusion Criteria:

- Participants with histologically confirmed melanoma (unresectable Stage IIIc and Stage
IV metastatic melanoma, as defined by American Joint Committee on Cancer [AJCC])

- Measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) Version
(V) 1.1

- Eastern Cooperative Oncology Group (ECOG) Performance Status of less than or equal to
(
- Participants must

1. be previously untreated for locally advanced/unresectable or metastatic melanoma
or

2. previously treated but without prior exposure to any BRAF or MEK inhibitor
therapy or

3. progressed on vemurafenib while participating in a Phase I (including clinical
pharmacology studies), II, or III clinical study or expanded access programs
(EAP) immediately prior to enrollment in this study or

4. progressed on vemurafenib administered in a postmarketing setting immediately
prior to enrollment in this study.

- Life expectancy >/=12 weeks

Exclusion Criteria:

- History of prior significant toxicity from another RAF or MEK pathway inhibitor
requiring discontinuation of treatment

- Palliative radiotherapy within 2 weeks prior to first dose of study drug treatment

- Experimental therapy within 4 weeks prior to first dose of study drug treatment except
vemurafenib

- Major surgery within 4 weeks of first dose of study drug treatment or planning a major
surgery during the study

We found this trial at

sites

Indiana University - Department of Medicine, Division of Gastroenterology/Hepatology

340 West 10th Street
Indianapolis, Indiana 46202

from

Indianapolis, IN