14 results
Primary aim: Stepwise feasibility study to investigate whether intravenously administered macrophage tracers [11C]DPA-713, [18F]DPA-714 and/or [18F]PEG-folate accumulate in inflamed joints of rheumatoid arthritis patients using PET(-CT).Secondary…
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 objective of this study is to determine how well two different doses of ipilimumab work in patients with prostate cancer who are no longer responding to hormone therapy (castration resistant), and whom have the best radiographic progression-…
The purpose of this study is to determine the safety and efficacy of post-surgery treatment with the monoclonal antibody ipilimumab, to see whether treatment improves recurrence-free survival (RFS), overall survival and distant metastases-free…
Primary: superiority of dabrafenib and trametinib combination therapy over vemurafenib monotherapy with respect to overall survival for subjects with advanced/metastatic BRAF V600E/K mutation-positive cutaneous melanoma.Secondary: progression free…
The primary objective is to determine the safety, tolerability, dose-limiting toxicities (DLTs), and maximum tolerated dose (MTD)/recommended Phase 2 dose (RP2D) of BMS-986178 administered alone or in combination with nivolumab and/or ipilimumab in…
Primary objectives: To explore the safety, feasibility, and the immune-activating capacity of different schemes of continuous/intermittent dabrafenib+trametinib during treatment with pembrolizumab as compared to pembrolizumab monotherapySecondary…
Primary objectives Phase I: To determine the recommended phase 2 dose (RP2D) of the lapatinib-trametinib combination in patients with KRASm NSCLC Phase II: To determine the progression free survival of the lapatinib-trametinib combination compared…
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-…
This drug-drug interaction (DDI) study is being conducted to determine if there is a pharmacokinetic (PK) interaction between trametinib and the components of combination oral contraceptives (OCs), norethindrone (NE) and ethinyl estradiol (EE).…
PRIMARY- Phase Ib: To define the maximum tolerated dose (MTD) and/or the recommended Phase 2 regimen (RP2R) of ribociclib and trametinib in patients with solid tumors- Phase II: To assess overall response rate (ORR) with the combination of…
Primary objective:• To assess the safety and feasibility of adding ipilimumab-nivolumab to a CRT induction protocol• To assess the efficacy of adding ipilimumab-nivolumab to CRT on the likelihood of a pCR and MPRSecondary objectives: • Local and…
Primary: overall response rate.Secondary: progression free survival, duration of response, overall survival, safety, tolerability, pharmacokinetics (PK).
Primary objective: Response to trametinib treatment defined as a tumor volume decreases from baseline of >=20%, monitored by using volumetric MRI analysis. Secondary objectives are: patient reported outcomes of pain and disability and quality…