Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Hoffmann-La Roche
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible 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
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
You may not be 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
Clareo Health | A Study of Vemurafenib and GDC-0973 (Cobimetinib) in Participants With BRAFV600E Mutation-Positive Metastatic Melanoma
