13 results
The objectives of this study are to demonstrate that Nepafenac Ophthalmic Suspension, 0.3% is not inferior to Nepafenac Ophthalmic Suspension, 0.1% (NEVANAC®); Nepafenac Ophthalmic Suspension, 0.3% is superior to Nepafenac 0.3% Vehicle and NEVANAC…
To evaluate safety and the effect of isolated limb perfusion together with nivolumab as a way to increase efficacy and give further insights in early immunological mechanisms. In the first phase Ib part, 20 patients will be enrolled and followed for…
Primary Objectives - To compare Overall Survival (OS) and Progression free survival (PFS) of nivolumab monotherapy to ipilimumab monotherapy and that of nivolumab combined with ipilimumab to ipilimumab monotherapy in subjects with previously…
Primary ObjectivePart A: To compare disease-free survival (DFS) per Blinded Independent Central Review (BICR) of nivolumab combined with ipilimumab versus placebo infusions in participants with localized RCC, with a predominantly clear cell…
We hypothesise that treatment with nivolumab will extend disease-free survival, compared with placebo, as adjuvant therapy in all randomized patients and in patients with PD-L1 expressing tumours (membranous staining in > 1%) who are at high…
The aim of the study is to compare overall survival (OS) and Blinded Independent Central Review (BICR)-assessed progression free survival (PFS), of nivolumab, and nivolumab in combination with ipilimumab, versus placebo in subjects with ED-SCLC…
Primary objectives: This study has co-primary objectives:• To compare OS of nivolumab versus placebo in subjects with resected EC or GEJ cancer. • To compare DFS of nivolumab versus placebo in subjects with resected EC or GEJ cancer. Secondary…
The aim of the study is to compare the Overall Response Rate (ORR) and assess Duration of Response (DoR) of the treatment of nivolumab in combination with ipilumumab vs. nivolumab in combination with ipilimumab placebo, as determined by a blinded…
Primary Objective:To measure the efficacy provided by nivolumab therapy on its own compared to placebo in participants who have had their stage IIB/C cancer completely removed, and have no evidence of disease, but are at high risk of recurrence.…
Primary Objective:To evaluate the safety and tolerability of FL-101 as monotherapy and in combination with nivolumabTimepoint of evaluation of primary objective: From first dose to 3 months after surgerySecondary Efficacy Objectives1. Cohort 1: To…
The objective of this study is to evaluate the efficacy and safety of cabozantinib in combination with nivolumab and ipilimumab versus nivolumab and ipilimumab in previously untreated subjects with intermediate- and poor-risk advanced or metastatic…
Primary Objectives:* To determine the efficacy of daily oral DP13 treatment (all dose arms combined) to decrease the plasma aldosterone-to-renin ratio (ARR) from baseline in patients with primary aldosteronism (PA)* To determine the efficacy of…
Objectives of the studyPrimary ObjectiveTo compare recurrence-free survival (RFS)(based on BICR assessment) of nivolumab versus placebo in all randomized participants.Secondary Objectives• To compare overall survival (OS) of nivolumab versus placebo…