12 results
Primary Objectives:• To compare progression free survival (PFS) as determined by blinded independent central review (BICR) and overall survival (OS) of nivolumab combined with ipilimumab to pemetrexed plus cisplatin or carboplatin regimen as first…
To evaluate the pharmacodynamic (PD) effects of the study treatments (ACT-541468 50 mg, ethanol at a blood level of 0.6 g/L for 5 h) as co-administration in 4 different combinations (ACT-541468 plus ethanol, ACT-541468 alone, ethanol alone, and…
Primary Objective* To compare the objective response rate and overall survival of BMS-936558 to investigator*s choice in subjects with advanced melanoma.Secondary Objectives* To compare the progression-free survival (PFS) of BMS-936558 to…
Primary Objective: To compare Overall Survival (OS) of subjects with Stage IV/recurrent NSCLC of squamous histology who have been randomized to ipilimumab in addition to paclitaxel and carboplatin versus placebo in addition to paclitaxel and…
The study will look at patients with advanced Non-Small Cell Lung Cancer (NSCLC) whose tumours express a certain type of protein called PD-L1. The research aims to compare a new drug called nivolumab against Investigator's choice of…
The primary objective of the study is to determine the mean prediction error (MPE) and mean absolute prediction error (MAPE) of the area under the plasma concentration-time curve (AUC) of carboplatin after adjusted dosing for high BMI (BMI >…
1. Overall survival (primary efficacy endpoint)2a. Efficacy: progression-free survival (PFS), overall response rate (ORR = CR + PR), and a clincal benefit rate (CBR) will be evaluated as CR + PR + SD for at least 3 months.2b. Safety: adverse events…
Primary Objective: To compare overall survival (OS) of subjects randomized to ipilimumab in addition toplatinum and etoposide (Arm A) to that of subjects randomized to placebo in addition to platinum andetoposide (Arm B) in subjects with newly…
• To evaluate the tolerability and safety of ascending single oral doses of ACT-541468 in healthy male subjects.• To investigate the single oral dose pharmacokinetic (PK) and PD of ACT-541468 in healthy male subjects.• To investigate dose…
RO5479599 is an experimental drug under investigation by F. Hoffmann-La Roche for the treatment of solid tumors with a HER3 over-expressed, in this study focused on patients with advanced / metastatic non-small cell lung cancer (NSCLC) of squamous…
The main purpose of this research study is to find out if treatment of late relapse with liposomal doxorubicin (Caelyx) combined with carboplatin will control the tumor growth at least as well as standard treatment of paclitaxel and carboplatin.…
Primary objective- To evaluate the effects of ACT-541468 on objective simulated driving performance, i.e., the standard deviation of the lateral position (SDLP), after single- and multiple dose administrations (i.e., on Day 1 and Day 4) in the…