33 results
The objective of the study is to assess the efficacy and safety of Alirocumab in patients with heterozygote familial hypercholesterolemia whose LDL-C level is higher than or equal to 160 mg/dL (4.14 mmol/L) on maximally tolerated statin therapy with…
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…
In the present study, we set out to evaluate arterial wall inflammation in patients at increased CV-risk with statin-associated muscle symptoms (SAMS), precluding effective statin therapy. Following twelve weeks of treatment with PCSK9-Ab, the…
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
To assess arterial wall inflammation, measured with 18F-FDG PET/CT scan, in patients with intermediate and severe FH phenotype, as well as the change in arterial wall inflammation following PCSK9 inhibition.
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…
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…
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…
Primary objective* To assess the long-term safety of alirocumab when added to currently available lipid-modifying drug therapy in patients with heterozygous familial hypercholesterolemia (heFH) who have completed one of the following studies:…
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…
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…
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 (…
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…
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 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…
To determine the efficacy of subcutaneous administration of brodalumab compared with placebo in treating adolescents with moderate-to-severe plaque psoriasis.
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.
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.…
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…