20 results
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.…
The primary objective of the present study is to study influence of different types of electrical stimulation on functional hand opening. The secondary objective of the study is to gain more insight in muscle activation patterns and kinematics…
Primary objective: to investigate whether HPA-axis responses during the ACTH (Synacthen) stimulation are differentially influenced by distinct hormonal contraceptives, as compared to responses measured during the natural menstrual cycle (luteal…
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 investigate if determining dry-weight with the assistance of bioelectrical impedance analysis compared to the current practice will result in a better blood pressure control.
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…
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…
Determine the efficacy and safety (using objective response rate) of tremelimumab in patients with advanced solid tumors (UBC, PDAC, TNBC).
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/…
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 the efficacy of MEDI4736 + tremelimumab combination therapy versus SoC in terms of OS in patients with UC.
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
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…
(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 +…
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
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…
Primary Objective - To assess the safety of CIT-induction with Tremelimumab and Durvalumab, and CRT/R in stage III NSCLCSecondary objectives - To assess the efficacy of CIT-induction with Tremelimumab and Durvalumab , and CRT /R by establishing…
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…