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Clinical Trials/EUCTR2015-002615-15-NO
EUCTR2015-002615-15-NO
Active, not recruiting
Phase 1

A Phase Ib/II randomised open label study of BGB324 in combination with pembrolizumab or dabrafenib/trametinib compared to pembrolizumab or dabrafenib/trametinib alone, in patients with advanced non-resectable (Stage IIIc) or metastatic (Stage IV) melanoma - Combination study of BGB324 in melanoma

Helse Bergen HF, Haukeland universitetssjukehus0 sites92 target enrollmentStarted: June 20, 2016Last updated:
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ConditionsAdvanced non-resectable (Stage IIIc) or metastatic (Stage IV) melanomaMedDRA version: 21.1Level: LLTClassification code 10053571Term: MelanomaSystem Organ Class: 100000004864Therapeutic area: Diseases [C] - Cancer [C04]
DrugsKeytrudaTafinlarMekinist

Overview

Phase
Phase 1
Status
Active, not recruiting
Enrollment
92
OverviewEligibility CriteriaInvestigatorsRecords & IdentifiersSimilar Trials

Overview

Brief Summary

No summary available.

Study Design

Study Type
Interventional clinical trial of medicinal product

Eligibility Criteria

Sex
All

Inclusion Criteria

  • •Inclusion Criteria
  • •1\.Patients able to understand and willing to sign a written protocol specific informed consent and older than 18 years at the time of consent.
  • •2\.Histologically confirmed advanced cutaneous melanoma that is either non\-resectable (Stage IIIc) or metastatic (Stage IV) with:
  • •a.At least one measurable lesion as defined by RECIST 1\.1 on CT or MRI scan and
  • •b.Documented progression of \=1 measurable lesion
  • •3\.ECOG performance status 0 to 2 at screening
  • •4\.Availability of fresh or archival tumour tissue sample suitable for evaluation of predictive biomarkers of response
  • •5\.Male patients with female partners of childbearing potential and female patients of childbearing potential willing to practice highly effective birth control while onfrom screening, throughout the study and for at least 3 months following the last dose of study treatment (and if female of childbearing potential, has a negative serum pregnancy test in the 7 days before the first dose of BGB324study treatment)
  • •Are the trial subjects under 18? no
  • •Number of subjects for this age range:

Exclusion Criteria

  • •1\.Prior first line systemic treatment for the treatment of Stage IIIb or Stage IIIc melanoma, including BRAF or MEK inhibitor
  • •2\.Symptomatic central nervous system metastatic lesions as determined by Investigator
  • •3\.History of malignancy other than melanoma within the last 2 years (basal or squamous cell carcinoma of the skin or carcinoma in situ of the cervix; isolated elevation in prostate specific antigen in the absence of histological or radiographic evidence of prostate cancer is allowed)
  • •4\.History of or current active autoimmune diseases. Patients with vitiligo, or other non\-serious autoimmune diseases based on the Investigator’s assessment, are NOT excluded
  • •5\.FOR BRAF pos PATS: History of retinal vein occlusion (RVO) or ongoing retinal pigment epithelial detachment (RPED)
  • •6\.History of the following cardiac conditions:
  • •a.Congestive cardiac failure of \>Grade 2 severity according to the New York Heart Association (defined as symptomatic at less than ordinary levels of activity)
  • •b.Ischemic cardiac event including myocardial infarction within 3 months prior to first dose of study treatment
  • •c.Uncontrolled cardiac disease, including unstable angina, uncontrolled hypertension or need to change medication within 6 weeks of provision of consent due to lack of disease control
  • •d.History or presence of sustained bradycardia (\=55 bpm), left bundle branch block, cardiac pacemaker or ventricular arrhythmia. Note: Patients with a supraventricular arrhythmia requiring medical treatment, but with a normal ventricular rate are eligible

Investigators

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