19 results
Primary Objective: To compare overall survival (OS) of subjects randomized to ipilimumab in addition toplatinum and etoposide (Arm A) to that of subjects randomized to placebo in addition to platinum andetoposide (Arm B) in subjects with newly…
To evaluate the safety and efficacy in terms of progression-free survival (PFS) and overall survival (OS) of nintedanib + pemetrexed / cisplatin followed by nintedanib versus placebo + pemetrexed / cisplatin followed by placebo as first line…
Primary Objective:The objective of this study is to determine the efficacy of bIAP as a prophylactic agent against inflammation-mediated complications from more invasive cardiac surgery, aortic valve surgery and CABG with cardiopulmonary-bypass time…
The objective of this phase III study is to compare the efficacy of sorafenib in combination with gemcitabine and cisplatin versus placebo with gemcitabine and cisplatin for first-line treatment of patients with stage IIIB (with effusion) or Stage…
To establish the safety and and tolerability and early efficacy of Alkaline phosphatase in the treatment of sepsis patients with renal failure.
The research hypothesis for this study is that concurrent durvalumab plus SoC chemotherapy will be more effective than placebo plus SoC chemotherapy for the treatment of MRD+ patients who have undergone complete resection of stage II-III NSCLC when…
Pertuzumab is the investigational agent being studied for the treatment of HER2-positive gastric cancer. This study is to compare the overall survival (OS) in patients treated with pertuzumab in addition to trastuzumab (Herceptin®) plus cisplatin…
Run-in phase I: To confirm the safety and tolerability of BIBF 1120 up to a dose level of 200 mg b.i.d added to a standard dose of cisplatin/gemcitabine in first line NSCLC patients with squamous cell histology. Pharmacokinetics of BIBF 1120 and…
There are two primary objectives in this study: The first of them is to evaluate in a blinded randomized trial, whether the hypoxic cell radiosensitizer nimorazole can improve the effect of primary curative accelerated fractionated concomitant chemo…
The primary objectives of the study are as follows:• To investigate the effect of recAP on renal function and related clinical parameters in patients with SA-AKI.• To determine the therapeutic dose(s) of recAP to support the pivotal Phase 3 program.…
The primary efficacy objective for this study is to evaluate the efficacy of atezolizumab plus gemcitabine/carboplatin or cisplatin compared with placebo plus gemcitabine/carboplatin or cisplatin on the basis of the following endpoints:- Co-primary…
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…
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…
Primary Objectives:- To assess the efficacy of durvalumab + dCRT compared with placebo + dCRT in all randomized patients based on PFS (per RECIST 1.1 as assessed by BICR)- To assess the efficacy of durvalumab + dCRT compared with placebo + dCRT in…
To assess the (long-term) efficacy of clemastine fumarate in improving dysconjugacy of eye movements in patients with internuclear ophthalmoparesis and multiple sclerosis. Secondly, to assess whether a response to a single dose of fampridine can…
The purpose of this study (APPIRED III) is to investigate the efficacy of administered prophylactically RESCAP with regard to the prevention of (severe) renal failure, or renal dysfunction, reducing morbidity and mortality. It also looks at systemic…
Primary: To compare Event-free survival (EFS) per RECIST in subjects treated with pembrolizumab in combination with CRT and subjects treated with placebo in combination with CRT.Secondary:(1) To compare Overall Survival (OS) in subjects treated with…
Primary Objective1. To evaluate the antitumor activity of pembrolizumab in combination with chemotherapy compared with saline placebo in combination with chemotherapy using PFS per RECIST 1.1 as assessed by BICR of imaging.2. To evaluate the…
Primary objectives:(1) Evaluate Progression Free Survival (PFS) per RECIST 1.1 as assessed by blinded central radiologists' review in subjects with PD-L1 Combined Positive Score (CPS) *1. (2) Evaluate overall survival (OS).Secondary Objectives(…