POLARIS : A Phase 2, Open-Label, Randomized, Multicenter Trial of Encorafenib + Binimetinib Evaluating a Standard-dose and a High-dose Regimen in Patients With BRAFV600-mutant Melanoma Brain Metastasis

Male or<br/>FemaleGender Male or
Female

RecruitingStatus Recruiting

Systemic<br/>Therapy TrialTypeSystemic
Therapy Trial

TwoPhase Two

18+Age Over 18

Skin<br/>CancersCancer LocationSkin
Cancers

Systemic therapy | SkinMelanoma (Skin)

Trial Overview Read MoreRead more

This phase II trial is testing a targeted therapy combination (with encorafenib and binimetinib) in patients with BRAFV600 melanoma that has spread to the brain.
 

This trial is treating patients with BRAFV600 melanoma.

This is a systemic therapy trial.

You may be able to join this trial if:

  • 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 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 2, Open-Label, Randomized, Multicenter Trial of Encorafenib + Binimetinib Evaluating a Standard-dose and a High-dose Regimen in Patients With BRAFV600-mutant Melanoma Brain Metastasis

Commercial Sponsor

Array BioPharma

Summary

Eligible participants will be randomised to receive oral encorafenib and binimetinib in 28-day cycles across two different dosing regimens. In the standard-treatment arm, participants will receive 450 mg encorafenib orally once a day (QD) and 45 mg binimetinib orally twice a day (BID); in the high-dose treatment arm, participants will receive 300 mg encorafenib orally twice a day (BID) and 45 mg binimetinib orally twice a day (BID).

Recruiting Hospitals Read MoreRead more

Alfred Hospital, Medical Oncology
Prahran
Ms Eleanor Edwards
El.Edwards@alfred.org.au
03 9076 2297

PCCTU (Parkville Cancer Clinical Trials Unit) *
Parkville
Enquiries Line Coordinator
clinicaltrials.enquiries@petermac.org
03 8559 7456 (9am-2pm, Mon-Fri)

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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