7 results
Primary: overall response rate.Secondary: progression free survival, duration of response, overall survival, safety, tolerability, pharmacokinetics (PK).
Primary: superiority of dabrafenib and trametinib combination therapy over dabrafenib and trametinib-placebo (dabrafenib monotherapy) with respect to progression-free survival (PFS) for subjects with advanced/metastatic BRAF V600E/K mutation-…
Primary objectives: To assess the ability of dabrafenib + trametinib treatment to downsize melanoma tumor masses to enable R0-resection. Secondary objectives: Recurrence free survival; time-to-next treatment, overall survival.
The main objective of this study is to determine whether tumor concentrations of kinase inhibitors at pharmacological active doses can be predicted from PET studies using tracer amounts (microdosing) of corresponding radiolabeled kinase inhibitors.…
Primary objectives:1) To evaluate the safety of four different CHMI-trans protocols in healthy malaria-naïve volunteers challenged with Plasmodium falciparum by sporozoite challenge. 2) To determine the best CHMI-trans protocol for induction of…
To demonstrate that a dose reduction of 20-33% of CYP3A4 metabolized tyrosine kinase inhibitors in patients expressing the CYP3A4*22 gene (rs35599367 C>T in intron 6) does not result in a lower exposure (Ctrough) than the wildtype group with…
* Safety Run inTo determine the recommended regimen of PDR001 in combination with dabrafenib and trametinib for the randomized part (part 3)* Biomarker cohortTo evaluate changes in the immune microenvironment and biomarker modulations upon treatment…