5 results
EFFICACY OBJECTIVESWithin each cohort, the study has the following co-primary efficacy objectives:· Assessing early efficacy during the Maintenance Treatment Phase based on a 20%reduction in tumour size after 2 months of treatment· Evaluating PFSThe…
Primary Objective:*Evaluate the safety and tolerability of AMG 596 administered by continuous intravenous (cIV) infusion in monotherapy (Arm 1) and in combination with AMG 404 (anti-programmed cell death-1 (PD-1) antibody( Arm 2) in subjects with…
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…
To evaluate the efficacy of cobimetinib plus atezolizumab compared with pembrolizumab, as measured by the primary endpoint of progression-free survival (PFS) by independent review
Primary objective:- To compare efficacy of induction vemurafenib + cobimetinib followed by ipilimumab + nivolumab (Arm A) versus upfront ipilimumab + nivolumab treatment (Arm B).Secondary Objectives- To describe duration of response and overall…