CELEBRATE : A Phase 1B Study to Evaluate the Safety, Tolerability and Preliminary Efficacy of the Combination of Encorafenib, Binimetinib and Palbociclib in Patients With BRAF-mutant Metastatic Melanoma (The CELEBRATE Study)

Male or<br/>FemaleGender Male or
Female

RecruitingStatus Recruiting

Systemic<br/>Therapy TrialTypeSystemic
Therapy Trial

One/TwoPhase One/Two

18-100Age 18-100

Skin<br/>CancersCancer LocationSkin
Cancers

Systemic therapy,Treatment | SkinMelanoma (Skin)

Trial Overview Read MoreRead more

This phase I/II trial will begin to understand how safe, well tolerated and effective a combination therapy is for the treatment of BRAF-mutant melanoma that has spread to other parts of the body.
 

This trial is treating patients with BRAF-mutant melanoma.

This is a systemic therapy trial.

You may be able to join this trial if:

  • You are able to swallow medication by mouth.
  • 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.

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

Clinical Summary Read MoreRead more

Trial Identifiers

Use the hyperlinks, where available to access additional clinical trial information.

Scientific Title

A Phase 1B Study to Evaluate the Safety, Tolerability and Preliminary Efficacy of the Combination of Encorafenib, Binimetinib and Palbociclib in Patients With BRAF-mutant Metastatic Melanoma (The CELEBRATE Study)

Other Non-Commercial Sponsor

Peter MacCallum Cancer Centre

Summary

This trial contains a dose escalation phase and a dose expansion phase, designed to assess the safety, tolerability, and pharmacokinetics of encorafenib, binimetinib and palbociclib in combination for the treatment of BRAF-mutant metastatic melanoma. Patients with untreated or previously treated BRAFV600 mutation-positive, locally advanced/unresectable or metastatic melanoma are eligible. In the dose escalation phase of the trial, eligible patients will raceive 450mg oral Encorafenib daily, Binimetinib twice daily and a variable dose of Palbociclib daily for 21 consecutive days on treatment, followed by 7 days off treatment in a 28-day cycle. Alternate dosing regimens and schedules may be interrogated depending on the nature and timing of the toxicities encountered. Approximately 30 additional patients will be enrolled into two dose expansion cohorts. One cohort will consist of previously untreated patients or treated patients without prior exposure to any BRAF and MEK inhibitor therapy. The second cohort will consist of patients who have progressed on BRAF and MEK inhibitor therapy. A minimum of 10 patients in each cohort must have newly obtained tumour sample at baseline. Accrual may be restricted to achieve this. Treatment of patients in both phases will continue until disease progression, unacceptable toxicity, or any other discontinuation criterion is met.

Recruiting Hospitals Read MoreRead more

Austin Health
Heidelberg
Ms Samantha Chakar
samantha.chakar@austin.org.au
03 9496 3088

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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