Phase 3
N=514
A Study of Atezolizumab Plus Cobimetinib and Vemurafenib Versus Placebo Plus Cobimetinib and Vemurafenib in Previously Untreated BRAFv600 Mutation-Positive Patients With Metastatic or Unresectable Locally Advanced Melanoma
Melanoma
Bottom Line
View on ClinicalTrials.gov: NCT02908672 ↗Enrolled (actual)
514
Serious AEs
25.5%
Results posted
Nov 2020
Primary outcome: Primary: Progression-Free Survival (PFS), as Determined by Investigator Using Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 — 10.6; 15.1 months — p=0.0224
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Atezolizumab (Drug); Atezolizumab Placebo (Drug); Cobimetinib (Drug); Vemurafenib (Drug); Vemurafenib Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Hoffmann-La Roche
- Primary completion
- Oct 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Progression-Free Survival (PFS), as Determined by Investigator Using Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 |
10.6; 15.1 | 0.0224 sig |
| SECONDARY PFS as Determined by Independent Review Committee (IRC) Using RECIST v1.1 |
12.3; 16.1 | 0.1607 |
| SECONDARY Percentage of Participants With Objective Response (OR), as Determined by Investigator Using RECIST V1.1 |
65.0; 66.7 | 0.6997 |
| SECONDARY Duration of Response (DOR), as Determined by Investigator Using RECIST v1.1 |
12.6; 21.0 | — |
| SECONDARY Overall Survival (OS) |
25.8; 39.0 | 0.1191 |
| SECONDARY Percentage of Participants Who Have Survived at 2 Years |
53.31; 61.50 | 0.0693 |
| SECONDARY Time to Deterioration in Global Health Status (GHS) Determined Using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) Scale Score |
NA; 14.4 | — |
| SECONDARY Time to Deterioration in Physical Functioning (PF) Determined Using EORTC QLQ-C30 Scale Score |
22.4; 17.5 | — |
| SECONDARY Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) |
99.6; 100; 43.0; 50.9 | — |
| SECONDARY Serum Concentration of Atezolizumab |
281; 102; 149; 181; 431; 122 | — |
| SECONDARY Plasma Concentration of Cobimetinib Dose: 20/40 mg |
79.9; 144; 167; 216; 108; 92.3 | — |
| SECONDARY Plasma Concentration of Cobimetinib Dose: 60 mg |
169; 216; 278; 375; 150; 151 | — |
| SECONDARY Plasma Concentration of Vemurafenib |
38.9; 27.0; 41.3; 28.0; 39.2; 24.7 | — |
| SECONDARY Percentage of Participants Positive for Anti-drug Antibodies (ADA) to Atezolizumab |
1.4; 13.3 | — |
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.
Eligibility Criteria
Inclusion Criteria
- Females of child bearing potential and males with female partners must and use of contraceptive methods with a failure rate of less than or equal to ( /=18 weeks
- For participants not receiving therapeutic anticoagulation: International normalized ratio (INR) or activated partial thromboplastin time (aPTT) less than or equal to ( /=3 hemorrhage or bleeding event within 4 weeks prior to initiation of study treatment
- History of stroke, reversible ischemic neurological defect, or transient ischemic attack within 6 months prior to initiation of study treatment
Data sourced from ClinicalTrials.gov (NCT02908672). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.