Trials / Terminated
TerminatedNCT03273153
A Study of Cobimetinib Plus Atezolizumab Versus Pembrolizumab in Participants With Previously Untreated Advanced BRAFv600 Wild-Type Melanoma
A Phase III, Open-Label, Multicenter, Two Arm, Randomized Study to Investigate the Efficacy and Safety of Cobimetinib Plus Atezolizumab Versus Pembrolizumab in Patients With Previously Untreated Advanced BRAF V600 Wild-Type Melanoma
- Status
- Terminated
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 446 (actual)
- Sponsor
- Hoffmann-La Roche · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This is a Phase III, multicenter, open-label, randomized study designed to evaluate the efficacy, safety, and pharmacokinetics of cobimetinib plus atezolizumab compared with pembrolizumab in treatment-naive participants with advanced BRAFV600 wild-type melanoma.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Cobimetinib | Cobimetinib 60 mg tablets orally once daily on a 21 days on, 7 days off schedule. |
| DRUG | Atezolizumab | Atezolizumab 840 mg as IV infusion once in every 2 weeks. |
| DRUG | Pembrolizumab | Pembrolizumab 200 mg as IV infusion once in every 3 weeks. |
Timeline
- Start date
- 2017-12-11
- Primary completion
- 2019-04-15
- Completion
- 2021-02-19
- First posted
- 2017-09-06
- Last updated
- 2022-09-21
- Results posted
- 2020-06-09
Locations
121 sites across 15 countries: United States, Australia, Belgium, Brazil, France, Germany, Greece, Hungary, Italy, Netherlands, Poland, Russia, South Korea, Spain, United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03273153. Inclusion in this directory is not an endorsement.