An open label, multi-center roll-over study to assess long-term safety in patients who are ongoing or have completed a prior global Novartis or GSK sponsored Tafinlar (dabrafenib) and/or Mekinist (trametinib) study and are judged by the investigator to benefit from continued treatment

The purpose of this roll-over study is to better characterize long-term safety
in patients who are receiving treatment with dabrafenib and/or trametinib in a
Novartis-sponsored Global Drug Development (GDD), Global Medical Affairs (GMA)
or a former GSK-sponsored study that has reached its study objectives, and are
unable to access dabrafenib and/or trametinib outside of a clinical trial.
Subjects must be benefiting from treatment on the parent study as judged by the
Investigator.

This study has been transitioned to CTIS with ID 2023-509318-13-00 check the CTIS register for the current data.

This is an open-label, multi-center, roll-over study designed to provide
continued access to subjects who have previously participated in a dabrafenib
and/or trametinib parent study and who have fulfilled the requirements for the
primary objective, and who in the opinion of the Investigator, would benefit
from continued treatment. At the completion of their parent study, subjects may
be eligible to continue into the roll-over study in order to receive treatment
for as long as they continue to demonstrate benefit, or until one of the
discontinuation criteria is met.

Subjects will be enrolled from parent studies for the treatment of BRAF V600
mutation positive tumors which may include, but are not limited to,
unresectable or metastatic melanoma, NSCLC, ATC, biliary tract cancer,
gastrointestinal stromal tumors, high-grade glioma, low-grade
glioma,non-seminomatous/non-germinomatous germ cell tumors, adenocarcinoma of
small intestine, colorectal cancer, hairy cell leukemia, and multiple myeloma.
Subjects in this study may receive one of the following treatments received in
the parent study which are:
* Subjects who received monotherapy of either of dabrafenib or trametinib solid
dose forms
* Subjects who received combination of dabrafenib and trametinib solid dose
forms
There will be no screening period for this study. Once eligible subjects
provide consent, they can start treatment with study drug as soon as they enter
the study. All subjects must report to the study site for their first visit and
commence study participation. Subject should return to the study center for
resupply of study medication, clinical and safety assessment every 12 weeks
(+/- 2 week). The subject may return to the study site at any given time for
routine clinical assessments and local standard of care, however data from
these visits, outside from what is specified in this protocol will not be
captured in the eCRF. At every quarterly visit, the Investigator is required to
confirm that the subject continues to have favorable clinical benefit and may
continue receiving study treatment. All adverse events and serious adverse
events will be collected continuously throughout the study. Subjects will
continue to be treated until one of the discontinuation criteria is met. A
subject will reach the end of study when dabrafenib and/or trametinib is
permanently discontinued and the end of treatment visit has been performed. All
subjects will be followed up for safety for 30 days after the last dose of
study or until SAE is resolved as required, whichever is later. The study
duration will be assessed 10 years after the first subject*s first visit in
this clinical study, or will remain open until treatment becomes commercially
available and reimbursed, or another access program becomes available,
whichever comes first.

Treatment with dabrafenib and trametinib.

Side effects of treatment
Hospital visits: every 12 weeks until progression.
Prenancytest (if relevant) every month at home (urine test).
Prenancytest (if relevant) baseline and end of treatment visit (in clinic,
blood).