34 results
Aim of the study is to investigate what the influence is of insomnia on driving performance and to what extent this influence is attenuated by the use of hypnotics. Therefore, over-the-road driving performance of treated and untreated patients…
This study will evaluate the long-term safety and efficacy of atezolizumab in patients with locally advanced or metastatic NSCLC who have progressed following standard systemic chemotherapy (including if given in combination with anti-PD-1 therapy…
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…
The primary and secondary efficacy objectives analysis will be performed in patients who are PD-L1 positive (defined as IHC 2 and IHC 3 on the basis of tumor PD-L1 expression) and when appropriate may be performed in different patient subpopulations…
Primary objective:• To evaluate the 2-year disease free survival (DFS)Secondary objectives:• To evaluate toxicity and asses the relation of adverse events in time to recovery of the T-cell repertoire• To evaluate the 2-year overall survival (OS)• To…
The primary objective is efficacy of atezolizumab in advanced penile cancer patients measured by progression-free survival.
This study will evaluate the efficacy and safety of tiragolumab plus atezolizumab compared with placebo plus atezolizumab in patients with previously untreated locally advanced, unresectable or metastatic PD-L1 selected NSCLC, with no EGFR mutation…
To determine the real-world pharmacokinetics of ICIs.
The main objective of the trial is to determine the pathological response rate in cohort 1 and the radiological response rates in cohort 2, 3 and 4. The secondary objectives of the trial are the safety of atezolizumab and tiragolumab, the response…
Modified objectives after implementation of protocol amendment February 2017: Primary: 1. Validate the BRCA-like test* in predicting differential PFS with first line alkylating and platinum agents when compared to paclitaxel in TNBC Secondary: 1.…
The purpose of the study is to investigate how quickly and to what extent MYL-1401H is absorbed and eliminated from the body (this is called pharmacokinetics) as compared to Neulasta® EU and US. It will also be investigated what the effect is of MYL…
The primary objectives of this study are:* To describe the safety and tolerability of cergutuzumab amunaleukin in combination with atezolizumab* To determine the MTD, if achieved, of cergutuzumab amunaleukin in combination with atezolizumab* To…
Phase1: To characterize the safety and tolerability of isatuximab in combination with atezolizumab in participants with unresectable hepatocellular carcinoma (HCC), platinum-refractory recurrent/metastatic squamous cell carcinoma of the head and…
Unless otherwise specified, efficacy objectives will be analyzed for the following two treatment comparisons:• Atezolizumab + carboplatin + nab-paclitaxel (Arm B) versus carboplatin + nab- paclitaxel (Arm C)• Atezolizumab + carboplatin + paclitaxel…
This study will evaluate the efficacy, safety, and pharmacokinetics of atezo + cobi + vem compared with placebo plus cobimetinib plus vemurafenib (placebo+ cobi + vem) in patients with previously untreated, BRAFV600 mutation*positive, metastatic or…
To evaluate the efficacy of cobimetinib plus atezolizumab compared with pembrolizumab, as measured by the primary endpoint of progression-free survival (PFS) by independent review
Primary Efficacy ObjectivesUnless otherwise specified, efficacy objectives will be analyzed for the following two treatment comparisons:• Atezolizumab + carboplatin + paclitaxel + bevacizumab (Arm B) versus carboplatin + paclitaxel + bevacizumab (…
This study is being conducted to evaluate the safety of atezolizumab as second-line treatment for locally advanced or metastatic urothelial or non-urothelial carcinoma of the urinary tract. The study includes evaluation of the efficacy of…
The primary objective of the study is to assess the efficacy and safety of 3 different treatment arms (bevacizumab alone, atezolizumab-bevacizumab combination with acetylsalicylic acid and atezolizumab-bevacizumab combination with placebo) in…
This study will evaluate the efficacy and safety of multiple therapies that are selected using somatic alterations and potential predictive biomarkers identified via NGS assays in patients with solid tumors.