8 results
To characterize safety, tolerability, pharmacodynamic effects, and pharmacokinetics of the oral sGC stimulator BAY 1021189 in addition to standard therapy for heart failure with reduced EF (HFrEF) over 12 weeks in patients with worsening chronic…
The effect of correction of metabolic acidosis in chronic kidney disease on intrarenal RAS activity.
Primary Objective: - To study if sodiumbicarbonate therapy in patients with metabolic acidosis due to chronic kidney disease diminishes intrarenal RAS activity (without affecting the systemic RAS).Secondary Objective(s): - To study if…
Primary:- To evaluate the antitumor activity of the combination of encorafenib, binimetinib and cetuximab by assessing the confirmed overall response rate (cORR) by local radiologist/investigator assessment in adult subjects with previously…
Primary ObjectiveSafety Lead-in* Evaluate the safety of a high-dose regimen of encorafenib + binimetinib combination therapy in patients with BRAFV600-mutant melanoma who have asymptomatic brain metastasisPhase 2If the high-dose regimen is…
Sub-study APhase 1b:To assess the DLT rate and estimate the MTD of sasanlimab in combination with encorafenib and binimetinib to determine the RP2D for the combination. Phase 2:To assess the durable ORR of sasanlimab in combination with encorafenib…
To characterize the safety and tolerability.1. To describe the available RFS data by treatment arm.2. To describe the available DMFS data by treatment arm.3. To describe-reported health-related quality of life (HRQoL) bytreatment arm.
Encorafenib/binimetinb combination therapy can possibly reduce tumor size and thus making surgical treatment less comprehensive. In addition, the treatment can potentially improve recurrence-free survival, overall survival, and distant metastases-…
- To monitor the safety and tolerability of binimetinib- To monitor the safety and tolerability of encorafenib