This phase 2 trial aims to test the safety and effectiveness of the combined treatment with pembrolizumab (Keytruda), trametinib (Mekinist) and dabrafenib (Tafinlar) for advanced melanoma. The main outcomes of this trial include overall survival (time from treatment until death from any cause), side effects and response rate to the treatment.
The details
Trametinib and dabrafenib block tumor growth by inhibiting enzymes necessary for cell growth. Pembrolizumab stimulates the immune system to kill cancer cells. A combination of these two treatments for advanced melanoma treatment could significantly benefit the patient. However, it is not clear whether they are safe and effective when used in combination.
The current trial will examine the effectiveness and side effects with this combined treatment. The main outcome to be measured will be the overall survival, the response to the treatment and to measure safety by the frequency of side negative effects.
Who are they looking for?
This trial will recruit 50 participants with metastatic (spread to other parts of the body) and or inoperable melanoma. Patients must be 18 years old or older and must have life expectancy greater than 3 months. Patients must have normal blood levels and must know their BRAF mutation status.
Participants must not have been treated previously with these drugs or received chemotherapy within 2 weeks of the start of this study. Patients must not have brain metastasis or any immune system disease. Patients must not be pregnant, have HIV, hepatitis B or C or any other cancers.
How will it work
BRAF-mutated patients will receive pembrolizumab by injection every 2 weeks, dabrafenib orally every 12 hours and trametinib orally every 12 hours. Non-mutated melanoma patients will only receive pembrolizumab and trametinib.
Response rate, overall survival and side effects will be assessed for the duration of the study, and for up to 2 years following.
