At a glance
ClinicalIndex Comparison Record- ✓Histologically confirmed Stage IV metastatic or unresectable Stage IIIc locally advanced melanoma
- ✓BRAFV600 mutation-positive status documented by clinical mutation test
- ✓Previously untreated with systemic anti-cancer therapy for melanoma (prior adjuvant interferon, IL-2, or vaccine allowed)
- ✓ECOG Performance Status 0 or 1
- ✕Untreated or actively progressing CNS lesions; brain metastases to brainstem, midbrain, pons, medulla, or within 10 mm of optic apparatus; leptomeningeal disease; or intracranial hemorrhage
- ✕History of clinically significant cardiac dysfunction or LVEF <lower limit of normal or <50%
- ✕Active or history of autoimmune disease or immune deficiency
- ✕History of stroke, reversible ischemic neurological defect, or transient ischemic attack within 6 months
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase III, Double-Blinded, Randomized, Placebo-Controlled Study of Atezolizumab Plus Cobimetinib and Vemurafenib Versus Placebo Plus Cobimetinib and Vemurafenib in Previously Untreated BRAFV600 Mutation-Positive Patients With Unresectable Locally Advanced or Metastatic Melanoma
In Brief
A Phase 3 clinical trial evaluating Atezolizumab, Atezolizumab Placebo, and 3 other interventions for Melanoma. Completed, enrolled 514 participants across 110 sites in 20 countries.
Detailed Summary
This is a Phase III, double-blinded, placebo-controlled, randomized, multicenter study designed to evaluate the efficacy, safety, and pharmacokinetics of atezolizumab + cobimetinib + vemurafenib compared with placebo + cobimetinib + vemurafenib in patients with previously untreated BRAFv600 mutation-positive metastatic or unresectable locally advanced melanoma.
Study Details
Timeline
Interventions
Will be administered as per the schedule described in individual arm.
Will be administered as per the schedule described in individual arm.
Will be administered as per the schedule described in individual arm.
Will be administered as per the schedule described in individual arm.
Will be administered as per the schedule described in individual arm.