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

Completed · Phase 1

Conditions studied: Malignant Melanoma

In brief

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.

Key facts

Study ID

NCT01271803

Run by

Hoffmann-La Roche

People needed

131

Starts

2011-02-17

Expected to finish

2017-12-12

Last updated by the study team

2019-07-29

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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 (</=) 1
• Participants must
• be previously untreated for locally advanced/unresectable or metastatic melanoma or
• previously treated but without prior exposure to any BRAF or MEK inhibitor therapy or
• 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
• progressed on vemurafenib administered in a postmarketing setting immediately prior to enrollment in this study.
• Life expectancy >/=12 weeks

You may not qualify if…

• 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

Where it is running

• UCLA Department of Medicine — Los Angeles, California, United States
• University of California at San Francisco — San Francisco, California, United States
• The Angeles Clinic and Research Institute, Santa Monica Office — Santa Monica, California, United States
• University of Colorado; Anschutz Cancer Pavilion — Aurora, Colorado, United States
• University of Chicago — Chicago, Illinois, United States
• Indiana University - Department of Medicine, Division of Gastroenterology/Hepatology — Indianapolis, Indiana, United States
• Karmanos Cancer Inst. ; Hudson Webber; Cancer Research Building — Detroit, Michigan, United States
• New York University Medical Center — New York, New York, United States
• Vanderbilt University Medical Center — Nashville, Tennessee, United States
• Peter Maccallum Cancer Institute; Medical Oncology — Melbourne, Victoria, Australia

Full record on ClinicalTrials.gov

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