58 results
The primary objective of this study is to assess whether *omics technologies are sensitive and specific enough to be used as a chemical risk assessment tool for humans. More specifically the study will demonstrate if there are different and / or…
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 compare the analgesic efficacy of intravenous versus rectal paracetamol as assessed by VAS scores, PCA morphine consumption.2)To assess the pharmacokinetic profile of intravenous and rectal paracetamol by intravenous plasma paracetamol and…
Primary objective: to study the pharmacokinetics and pharmacodynamics of paracetamol intravenously in preterm infants with a gestational age of less than 32 weeks:Secondary objective(s): to study the safety and dose-effect relationship of…
Objective: To investigate whether acetaminophen is effective in treating self-reported sleep problems.
Primary objective: - To study the pharmacokinetics of acetaminophen and metabolites in morbidly obese patients and compare with normal weight patients. Secondary objectives: - To compare the pharmacokinetics of acetaminophen and metabolites in…
Primary objective: To assess the effect of early treatment with paracetamol in a daily dose of 6 g for three consecutive days in patients with acute stroke and a body temperature of 36.5°C or above on the occurrence of a favorable functional outcome…
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…
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 safety and biodistribution of 89Zr-MEDI4736 and its uptake in tumor and target irAE tissues.
To assess the efficacy of durvalumab + BCG (induction and maintenance) combination therapy compared to BCG (induction and maintenance) alone in high-risk non-muscle-invasive bladder cancer patients.
Primary study aim:To determine the efficacy, in terms of the meadian progression-free survival, in patients with recurrent or metastatic endometrial cancer (including carcinosarcoma of the endometrium) receiving treatment with durvalumab and…
The treatment options currently available for MIBC- patients remain limited, current standard therapy is likely to result in modest improvements in long-term survival, and additional and alternative therapies are required for patients with MIBC.…
Primary objective:-To assess the efficacy of durvalumab plus olaparib combination therapy compared with durvalumab monotherapy in terms of PFS (Investigator-assessed)Secondary objectives:- To further assess the efficacy of durvalumab plus olaparib…
To evaluate PFS in participants treated with cCRT plus M7824 followed by M7824 or cCRT plus placebo followed by Durvalumab
The study objectives and endpoints described below will be evaluated for the following treatment regimens:• Arm A: Nivolumab + CCRT followed by nivolumab + ipilimumab maintenance• Arm B: Nivolumab + CCRT followed by nivolumab maintenance• Arm C:…
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…
The objective of this trial is to evaluate progression-free survival in synchronous oligometastatic NSCLC patients treated with induction immunotherapy, chemotherapy and SBRT to all metastases followed by definitive surgery or radiotherapy to the…
To determine the real-world pharmacokinetics of ICIs.
This Phase III study, the administration of durvalumab + chemotherapy prior to surgery, followed by administration of durvalumab after surgery, will be investigated in patients with resectable Stages II and III NSCLC. The efficacy of durvalumab will…