17 results
We aim to establish proof-of-concept for use of pembrolizumab as novel neo-adjuvant therapy in dMMR and POLE-EDM UC. When ICB proves to be feasible as defined in the primary endpoint (see 2.1), we will follow-up with larger studies to determine…
To evaluate the effect of 12 weeks subcutaneous evolocumab (140 mg pre-filled pen every 2 weeks) compared to placebo on post fat load non-HDL-C levels in 30 subjects with FD, in a multicenter, randomized, placebo-controlled, double-blind, crossover…
* Primary Objective: To evaluate the effect of evolocumab on fibrous cap thickness (FCT) in subjects with non ST elevation acute coronary syndrome (NSTE ACS) who are taking maximally tolerated statin therapy.* Secondary Objective(s): To evaluate the…
Patients with hyperlipidemie and an elevated Lp(a) will be asked to partipate in this study. This part potentially increases the risk of cardiovascular diseases. One of the reasons why Lp(a) is expected to increases this risk is that Lp(a)…
To characterize the safety and tolerability of long-term administration of evolocumab in subjects with known coronary artery disease andhypercholesterolemia.
Primary: To evaluate the effect of AMG 145 on the change in burden of coronary atherosclerosis as measured by percent atheroma volume (assessed with intravascular ultrasound, IVUS) in patients with coronary artery disease requiring angiography for a…
Main objective:English To determine the antitumor activity of SAR444245 in combination with other anticancer therapiesSecondary objectives: English - To assess the safety of SAR444245 when combined with other anticancer therapies- To assess other…
Primary:To determine the safety and tolerability and to establish a preliminary recommended Phase 2 dose (RP2D) of MK-5890 when used as monotherapy and in combination with pembrolizumab in the dose escalation and confirmation phase and the dose…
The primary efficacy objective of this trial is to evaluate the anti-tumor activity of pembrolizumab in subjects with any of a *basket* of rare malignancies (biomarker unselected and biomarker selected). ORR will be used as the primary endpoint per…
Primary objective:To demonstrate superiority of three dose levels of oral NNC0385-0434 versus placebo on percent change in LDL-C from baseline to week 12 in patients with established ASCVD or ASCVD risk on maximally tolerated statin dose and other…
The objection of the study is to assess the safety, tolerability, and effect on microvascular obstruction of study drug in subjects undergoing Percutaneous Coronary Intervention.NL specific sub-study:The aim of this substudy is to investigate…
The primary objective of the study is to demonstrate that lenvatinib in combination with everolimus (Arm A) or pembrolizumab (Arm B) is superior compared to sunitinib alone (Arm C) in improving progressionfree survival (PFS) (by independent imaging…
- To evaluate the effect of treatment with evolocumab, compared with placebo, on the risk for coronary heart disease (CHD) death, myocardial infarction (MI), or ischemic stroke, whichever occurs first, in subjects at high cardiovascular risk without…
Primary:• To evaluate the effect of inclisiran treatment on low density lipoprotein cholesterol (LDL-C) levels at Day 210 compared to Day 1 of this extension study. Secondary:• To evaluate the effects of inclisiran on the following: LDL-C levels…
Based on the success of the pilot feasibility study, we propose a follow-up efficacy study to explore neo-adjuvant ICB therapy as potential alternative for SoC adjuvant radio(chemo)therapy in MMRd UC.
To prospectively assess whether post-operative adjuvant therapy with pembrolizumab improves recurrence-free survival (RFS) as compared to placebo in high-risk patients with complete resection of Stage IIIA (> 1 mm metastasis), IIIB and IIIC…
PrimaryTo describe the safety and tolerability of 80 weeks of SC evolocumab when added to standard of care in pediatric subjects 10 to 17 years of age with HeFH or HoFH. Secondary Efficacy* To describe percent change and change from baseline in LDL-…