9 results
To demonstrate superiority with regard to overall survival (OS) of avelumab versus docetaxel in subjects with programmed death ligand 1 (PD-L1) positive (+; as determined by a companion diagnostic test under development), non-small cell lung cancer…
Primary Objective* To characterize the pharmacokinetics (PK) of different dosing regimens of avelumab and its relation to target occupancy (TO) in peripheral blood of patients with classical Hodgkin*s Lymphoma (cHL).Secondary Objectives* To evaluate…
Primary Objectives* Phase 1b lead-in: To assess safety and tolerability of a single dose level of avelumab in combination withincreasing dose levels of other immune modulators in combination with a single doselevel of avelumab in patients with…
To determine the most effective drug (iNO or IV sildenafil) for the treatment of PH in newborns with CDH and to reach evidence based dosing of this drug. Subsequently this drug will be added to the international guidelines for the treatment of…
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…
Primary ObjectiveTo demonstrate that avelumab in combination with axitinib is superior to sunitinib monotherapy in prolonging PFS or OS in the first-line treatment of PD-L1 positive patients with aRCC.Secondary Objectives* To demonstrate that…
To demonstrate superiority with regard to Progression Free Survival based on an Independent Review Committeeassessment of avelumab versus platinum-based doublet in NSCLC subjects with PD-L1+
Primary objective:- To assess safety, efficacy, and potentially select the most active treatment regimen among 3 treatment arms to advance to the Phase 3 component of the study.Secondary objectives:- Ph1b: evaluate PK & assess immunogenicity…
To demonstrate the benefit of maintenance treatment with avelumab plus BSC vs. BSC alone in prolonging overall survival (OS) in patients with unresectable locally advanced or metastatic UC whose disease did not progress on or following completion of…