29 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…
1. Primary objective: to investigate changes in BMD of the lumbar spine (LS) one year after treatment discontinuation in denosumab-treated women and in denosumab-treated women who received a single infusion of zoledronic acid after treatment…
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…
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…
Objective: To test feasibility and safety of alpha beta T-/CD19 B-cell depleted allo-SCT in high risk or relapsed acute leukaemia / MDS followed by an innate donor lymphocyte infusion (iDLI)
In this study we want to investigate whether the submission of zoledronic acid to neoadjuvant chemotherapy benefits the pathological complete response, and thus favors a better clinical outcome in patients with large ressectable or locally advanced…
Although these products have been used extensively in patients, the effect of these medications on experimental pain sensation has never been investigated. There is little knowledge about any direct effect of these medications on pain perception. In…
To determine if denosumab is non-inferior to zoledronic acid (Zometa) with respect to the first on-study occurrence of a skeletal-related event (SRE) in men with hormone-refractory prostate cancer and bone metastases.
To determine if denosumab is non-inferior to zoledronic acid (Zometa) with respect to the first on-study occurrence of a skeletal-related event (SRE) in subjects with advanced breast cancer and bone metastases.
To determine if denosumab is non-inferior to zoledronic acid with respect to the first on-study occurrence of a skeletal related event (SRE) in subjects with advanced cancers and bone metastases (or lytic bone lesions from multiple myeloma).SRE is…
The main goal of this study is to evaluate the effectiveness of the NESS L300 on walking skills, as compared to a conventional ankle-foot orthosis, in stroke patients with a drop foot.
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 investigate efficacy of neoadjuvant axitinib and avelumab in patients with localized renal cell carcinoma with moderate to high risk of recurrence .
Primary Objective:• Safety and tolerability of VXM01 in combination with avelumabSecondary Objectives:• Efficacy of VXM01 in combination with avelumab by assessment of tumor objective response rate (ORR) per Immunotherapy Response Assessment in…
The purpose of this study is to evaluate the safety and preliminary efficacy of avelumab in combination with M9241in subjects with metastatic or locally advanced unresectable solid tumors. This dose escalation study will establish a safe dose of…
The aim of the study is to develop PD-L1 PET/CT imaging in patients with NSCLC to noninvasively image PD-L1 expression in tumors and to determine the correlation with response to avelumab. For this purpose, two studies will be carried out to1:…
Primary Objective:* To evaluate ORR of avelumab in combination with talazoparib, in patients with locally advanced or metastatic solid tumors harboring BRCA1, BRCA2 or ATM defect.Secondary Objective:* To assess the overall safety and tolerability of…
The objective of this study is to demonstrate that use of the Sentinel® Cerebral Protection System significantly reduces the risk of periproceduralstroke (*72 hours) after transcatheter aortic valve replacement (TAVR).
Feasibility
Co Primary Objectives:1. To demonstrate that avelumab in combination with platinum based chemotherapy followed by avelumab maintenance (Arm C) is superior to platinum based chemotherapy alone followed by observation (Arm A) in prolonging progression…