30 results
Primary ObjectiveThe primary objective of this study is to evaluate the initial efficacy, safety, and tolerability of guselkumab in adult participants with moderate to severe hidradenitis suppurativa (HS).Secondary ObjectivesThe secondary objectives…
Primary objective: To investigate changes in inflammatory pathways induced by IL-23p19 blockade with guselkumab, in HS lesional skin at week 16 compared to baseline (t=0).Secondary objectives:- To determine the efficacy of 4 doses of guselkumab of…
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:• 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…
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…
Feasibility
To demonstrate that treatment with avelumab in combination with standard of care (SOC) CRT is superior to SOC CRT alone in prolonging progression-free survival (PFS) in front-line patients with high-risk (as defined in Inclusion Criterion 2),…
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…
Primary Objective* To demonstrate that avelumab given alone or in combination with Pegylatedliposomal doxorubicin (PLD) is superior to PLD alone in prolonging Overall Survival(OS) in patients with platinum -resistant/platinum-refractory ovarian…
Primary ObjectiveTo evaluate the preliminary safety and tolerability and the preliminary efficacy of cobimetinib administered as single agent (Arm A), cobimetinib + venetoclax (Arm B), and cobimetinib + venetoclax + atezolizumab (Arm C)Secondary…
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…
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…
Safety (Primary) ObjectiveThe primary objective for this study is as follows:- To evaluate the safety and tolerability of cobimetinib in children and young adults, including estimation of the maximum-tolerated dose (MTD) or the maximum administered…
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…
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 evaluate the efficacy, including clinical remission and endoscopic response, of guselkumab SC inductionSecondary objectives:- To evaluate the efficacy of guselkumab SC across a range of outcome measures- To evaluate the safety…
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 investigate efficacy of neoadjuvant axitinib and avelumab in patients with localized renal cell carcinoma with moderate to high risk of recurrence .
Induction Study 1 (Phase 2b Induction Dose-ranging Study)ObjectivesPrimary ObjectivesThe primary objectives of this study are, in participants with moderately to severely active UC:* To evaluate the efficacy of guselkumab as induction therapy.* To…