A Study of Cobimetinib Plus Atezolizumab Versus Pembrolizumab in Participants With Previously Untreated Advanced BRAFv600 Wild-Type Melanoma

Conditions

• Advanced BRAFV600 Wild-type Melanoma

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Cobimetinib — DRUG
  Cobimetinib 60 mg tablets orally once daily on a 21 days on, 7 days off schedule.
• Atezolizumab — DRUG
  Atezolizumab 840 mg as IV infusion once in every 2 weeks.
• Pembrolizumab — DRUG
  Pembrolizumab 200 mg as IV infusion once in every 3 weeks.

Study Details

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.

Key Dates

Start date

Dec 11, 2017

Status verified

Aug 2022

Primary completion

Apr 15, 2019

Completion

Feb 19, 2021

Study Design

Enrollment

446 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Cobimetinib and Atezolizumab
  Participants will receive 60 mg of cobimetinib orally from Days 1 to 21 along with 840 mg of atezolizumab by intravenous (IV) infusion on Days 1 and 15 of each 28-day cycle until investigator-determined disease progression, unacceptable toxicity, death, patient or physician decision to withdraw, or pregnancy, whichever occurs first. There will be no cobimetinib administration for 7 days (Days 22-28) in each cycle.
• Active Comparator: Pembrolizumab
  Participants will receive 200 mg of pembrolizumab administered by IV infusion every 3 weeks (Q3W) until investigator-determined disease progression, unacceptable toxicity, death, patient or physician decision to withdraw, or pregnancy, whichever occurs first.

Primary Outcome Measure

Progression Free Survival (PFS) as Determined by the Independent Review Committee (IRC) [ Time Frame: Every 8 weeks (wks) from Day (D) 1 of Cycle (C) 1 through approximately 16 months ]

Locations (23)

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