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
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
BGB324+dabrafenib and trametinib,
dabrafenib and trametinib
If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.
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