Last updated on March 2018

BGB324 in Combination With Pembrolizumab or Dabrafenib/Trametinib in Metastatic Melanoma

Brief description of study

The purpose of the study is to assess the safety and efficacy of BGB324 given together with standard treatment, pembrolizumab or dabrafenib and trametinib, compared to standard treatment alone,

Detailed Study Description

This is an investigator initiated randomized randomized clinical phase 1b/2 clinical trial comparing safety and efficacy of the Axl inhibitor BGB324 in combination with pembrolizumab or dabrafenib+trametinib with that of pembrolizumab or dabrafenib+trametinib alone. Patients with non-resectable stage III or stage IV melanoma will be stratified based on BRAF mutation and tumor load to start dabrafenib+trametinib (BRAF mutation and high tumor load) or pembrolizumab (BRAF wild type or BRAF mutation and low tumor load) in first line. The patients will be randomized 2:1 to receive BGB324 in combination with pembrolizumab or dabrafenib+trametinib or to receive pembrolizumab or dabrafenib+trametinib alone. A 3+3 dose escalation will be performed for the combination of BGB324 and dabrafenib+trametinib. There is a major focus on predictive markers of treatment response evaluated in blood samples and biopsies.

Clinical Study Identifier: NCT02872259

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Oddbjørn Straume, MD, PhD

Haukeland University Hospital
Bergen, Norway
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Marta Nyakas, MD, PhD

Oslo University Hospital, Radiumhospitalet
Oslo, Norway
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Jarle Karlsen, MD

St. Olavs Hospital
Trondheim, Norway
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Jürgen Geisler, MD, PhD

Akershus Univerisity Hospital
Lørenskog, Norway
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Anita Amundsen, MD

University Hospital of North Norway
Tromsø, Norway
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