Evaluation of Photosensitivity in Dabrafenib or Vemurafenib Treated Metastatic Melanoma Patients - a Phase IIa/IIb Study
Status:
Terminated
Trial end date:
2017-12-01
Target enrollment:
Participant gender:
Summary
The BRAF inhibitors dabrafenib and vemurafenib belong both two a new class of potent
anti-cancer drugs and are highly efficacious in tumors harboring the BRAF V600E mutation.
Both drugs seem to be equally efficacious; however, their toxicity profile seems to differ.
Serious phototoxicity has been observed in ~ 30% of patients treated with vemurafenib and in
~2 percent of patients treated with dabrafenib. These phototoxic reactions have developed in
spite of informing the patients of this possible adverse event and instructing them to
protect themselves. Manifestation of phototoxic reactions depends on the patient's habits of
exposure and their efforts to protect themselves. The true frequency of photosensitivity can
only be established by systematic photo-testing. In dermatology, standard test procedures
with different UV-wavelengths and dosages have been established and the primary goal of this
study will be to clarify the true rate of photosensitivity by these two BRAF-inhibitors.
Furthermore, systematic experience will be collected how to best protect patients from
phototoxic events. Dabrafenib and Vemurafenib are commercially available and considered
standard of care for BRAF mutant metastatic melanoma in Germany. As the number of patients
will not allow any conclusion with regard to efficacy or safety of vemurafenib, patients
randomized to vemurafenib in part 2 will only remain on study until completion of
phototesting.