16 results
To evaluate the outcome of FISH testing with a set of biomarkers with regard to the prognostic value and the diagnostic accuracy for both sporadic cholangiocarcinoma and PSC related cholangiocarcinoma. Subsequently we want to develop a valid…
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.…
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 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…
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…
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).
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-…
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 objectives of this study are to determine the accuracy of the device (1) to determine functional oxygen saturation (SpO2) compared to a reference device, and (2) to determine respiratory rate compared to visual observations. As a secondary…
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.
The main objective of this study is to validate the accuracy of the device to monitor the physical activity of a subject by comparing the measured values to the golden standard (video recording).
Dose-finding:-To determine the adult equivalent exposure/MTD/recommended Phase II pediatric dose of durvalumab monotherapy and durvalumab in combination with tremelimumab-To determine the safety profile of durvalumab monotherapy, or durvalumab in…
The primary objective of this proof of concept study will be to investigate whether the combined use of local tumor ablation/radiation plus immunomodulating drugs may induce a significant immune response in patient with incurable liver metastases…
To assess the concurrent validity of the FastFocus* Vital Sign Monitoring System classification algorithm that discriminates between lying, sitting/standing, and walking activities, and detects number of walking steps in hospitalised patients under…