CompletedPhase 3

A Study Comparing Vemurafenib Versus Vemurafenib Plus Cobimetinib in Participants With Metastatic Melanoma

United States495 participantsStarted 2013-01-08

Plain-language summary

To evaluate the efficacy of vemurafenib in combination with cobimetinib (GDC-0973), compared with vemurafenib and placebo, in previously untreated BRAF V600 mutation-positive patients with unresectable locally advanced or metastatic melanoma, as measured by progression-free survival (PFS), assessed by the study site investigator.

Who can participate

Age range18 Years

SexALL

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Exclusion criteria

✕. All known CNS lesions have been treated with stereotactic therapy or surgery, AND
✕. There has been no evidence of clinical and radiographic disease progression in the CNS for ≥ 3 weeks after radiotherapy or surgery

What they're measuring

Progression-free Survival

Timeframe: Baseline to the 21 July 2019 data cut-off (up to 7 years, 6 months)

Trial details

NCT IDNCT01689519

SponsorHoffmann-La Roche

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2014-05-09

Results submitted2015-07-01

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