23 results
Page 18 of the protocol (v1.0, 4-Nov-2013):The primary objectives of this study are:- To evaluate the efficacy of ciprofloxacin DPI administered BID intermittently for 28 days on study treatment / 28 days off study treatment or 14 days on study…
To determine the efficacy and safety of MEDI4736 evaluated as a single agent or in combination with tremelimumab in patients with metastatic pancreatic ductal adenocarcinoma (PDAC) whose disease has progressed on 5-FU-containing or gemcitabine-…
1) To determine clinical safety and tolerability of local i.d. administration of a single dose of tremelimumab in clinical stage II melanoma patients scheduled to undergo a SLN procedure. 2) To ascertain the immunological effects of local i.d.…
Primary ObjectiveThe primary objective is to assess safety and tolerability, describe the dose limiting toxicities (DLTs), and determine the maximum tolerated dose (MTD) or the maximum administered dose (MAD; in the absence of exceeding the MTD) for…
To assess the efficacy of MEDI4736 + tremelimumab combination therapy compared to SoC in terms of PFS and OS in patients with PD-L1- positieve (equal or greater than 25%) NSCLC.To assess the efficacy of MEDI4736 therapy compared to SoC in terms of…
This study is a Phase III, randomised, open label, multi-centre study assessing the efficacy and safety of MEDI4736 versus Standard of Care in NSCLC patients with PD-L1-positive tumours and the combination of MEDI4736 plus tremelimumab (MEDI4736+…
To assess safety and tolerability of the combination of SBRT and combined CTLA-4/PD-L1 inhibition. In addition immune modulatory effect of the combination of an ablative dose of radiotherapy to the primary tumor and response to durvalumab/…
The main objective of this study is to assess whether in-hospital administration of empagliflozin results in improvement in HF-related outcomes in patients hospitalised for acute heart failure (de novo or decompensated chronic HF) and after initial…
To examine the effects of mono- and combination therapy with linagliptin and empagliflozine on renal hemodynamics
To investigate the potential of preoperative initiation (7 days) and perioperative continuation (until day 2 after surgery) of empagliflozin 10 mg daily to reduce the acute kidney injury marker neutrophil gelatinase-associated lipocalin (NGAL) on…
To assess the efficacy of durvalumab +tremelimumab + EP treatment compared with EP in terms of OS and the efficacy of durvalumab + EP treatment compared with EP in terms of OS
To assess the efficacy of MEDI4736 + tremelimumab combination therapy versus SoC in terms of OS in patients with UC.
OBJECTIVESPrimary Objectives:To assess the safety and tolerability, describe the dose-limiting toxicities (DLTs), and determine the maximum tolerated dose (MTD) or the highest protocol-defined dose (in the absence of exceeding the MTD) for the…
Main protocol:To assess the incidence, severity, nature, seriousness, intervention/treatment, outcome, and causality, including immune-relatedness, of adverse events of special interest (AESIs) in patients who are treated with durvalumab and…
Determine the efficacy and safety (using objective response rate) of tremelimumab in patients with advanced solid tumors (UBC, PDAC, TNBC).
The main objective of this study is to assess the efficacy of tepotinib combined with osimertinib inparticipants with advanced or metastatic EGFRm+ NSCLC and MET amplification, determined centrally by FISH.The secondary objectives are the following:…
Primary objectives:- To assess the efficacy of durvalumab monotherapy compared to placebo in terms of PFS- To assess the efficacy of durvalumab monotherapy compared to placebo in terms of OS
(1) Main objective:Safety Run-In (SRI):To assess the safety and tolerability of durvalumab + tremelimumab + EV in participants with MIBC who are ineligible for cisplatin or who refuse cisplatinMain Study: To compare the efficacy of durvalumab +…
PART 1Cohort A (METex14 skipping alterations):• To assess the efficacy of tepotinib in subjects with locally advanced or metast. (NSCLC), harboring the METex14 skipping alterations or MET amplif., as per objective response acc. to RECIST v.1.1,…
The standard first-line therapy for mUC patients is platinum-based chemotherapy, most commonly cisplatin. For patients that progress during or after platinum-based chemotherapy, anti-PD(L)1 therapy can be used, showing durable responses in a subset…