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NCT02908672 : 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

Male or<br/>FemaleGender Male or
Female

RecruitingStatus Recruiting

Systemic<br/>Therapy TrialTypeSystemic
Therapy Trial

ThreePhase Three

18+Age Over 18

Skin<br/>CancersCancer LocationSkin
Cancers

Systemic therapy | SkinMelanoma (Skin)

Trial Overview Read MoreRead more

This phase III trial is trying to understand how safe and effective immunotherapy (atezolizumab) in combination with targeted therapy (cobimetinib and vemurafenib), compared to a placebo in combination with targeted therapy, is in people with previously untreated BRAFv600 mutation-positive metastatic or locally advanced melanoma.
 

This trial is treating patients with melanoma.

This is a systemic therapy trial.

You may be able to join this trial if:

  • You are able to swallow medication by mouth.
  • You have been diagnosed with cancer, but have not received any treatment.
  • Your cancer has not spread to other parts of the body.
  • Your cancer has spread to other parts of the body.

You may be excluded from this trial if:

  • You have a certain disease or psychological condition.
  • You have been diagnosed with a prior or secondary type of cancer.
  • You have had certain treatments, surgical procedures or drugs.

Clinical trials have complex eligibility criteria - talk to your doctor about your interest in this trial.

Clinical Summary Read MoreRead more

Trial Identifiers

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Scientific Title

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

Commercial Sponsor

Hoffmann-La Roche

Summary

This is a randomised, double-blind trial that has two experimental arm. In Experimental Arm 1, participants will receive Atezolizumab + Cobimetinib + Vemurafenib + Vemurafenib Placebo. There will be a Run-In Period (Cycle 1=28 days): where participants receive vemurafenib 960 mg (four, 240 mg tablets, orally twice daily) along with cobimetinib 60 mg (three, 20 mg tablets, orally once daily) on Days 1 to 21 followed by vemurafenib 720 mg (three, 240 mg tablets, orally twice daily) on Days 22 to 28 and vemurafenib placebo (1 tablet, orally twice daily) on Days 22 to 28. There will then be a Triple Combination Period (Cycle 1 onwards): where participants will receive atezolizumab 840 mg via intravenous infusion (IV) on Day 1 and 15, cobimetinib 60 mg (three, 20 mg tablets, orally once daily) on Days 1 to 21, vemurafenib 720 mg (three, 240 mg tablets, orally twice daily) on Days 1 to 28, and vemurafenib placebo (1 tablet, orally twice daily) on Days 1 to 28 of each 28-day cycle. In Experimental Arm 2, participants will receive Atezolizumab Placebo + Cobimetinib + Vemurafenib. In the Run In Period (Cycle 1=28 days), participants will receive vemurafenib 960mg (four, 240 mg tablets, orally twice daily) along with cobimetinib 60 mg (three, 20 mg tablets, orally once daily) on Days 1 to 21 followed by vemurafenib 960 mg (four, 240 mg tablets, orally twice daily) on Days 22 to 28. In the Triple Combination Period (Cycle 1 onwards), participants will receive Atezolizumab placebo via IV on Day 1 and 15, cobimetinib 60 mg (three, 20 mg tablets, orally once daily) on Days 1 to 21, and vemurafenib 960 mg (four, 240 mg tablets, orally twice daily) on Days 1 to 28 of each 28-day cycle.

Trial Overview: General information about a clinical trial. This section provides an overview of who might be able to join this trial and what type of treatment is involved.

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