7 results
OBJECTIVESPrimary Objectives:To assess the safety and tolerability, describe the dose-limiting toxicities (DLTs), and determine the maximum tolerated dose (MTD) or the highest protocol-defined dose (in the absence of exceeding the MTD) for the…
The objective of the RADIANCE-HTN study is to demonstrate the efficacy and verify the safety of the Paradise System in two distinct populations of hypertensive subjects. Prior to randomization, subjects will be hypertensive in the absence of…
Primary Objective - To assess the safety of CIT-induction with Tremelimumab and Durvalumab, and CRT/R in stage III NSCLCSecondary objectives - To assess the efficacy of CIT-induction with Tremelimumab and Durvalumab , and CRT /R by establishing…
The objective of the RADIANCE II Pivotal study is to demonstrate the effectiveness and safety of the Paradise System in subjects with Stage 2 hypertension on 0-2 medications at the time of consent. Prior to randomization, subjects will be…
(1) Main objective:Safety Run-In (SRI):To assess the safety and tolerability of durvalumab + tremelimumab + EV in participants with MIBC who are ineligible for cisplatin or who refuse cisplatinMain Study: To compare the efficacy of durvalumab +…
The standard first-line therapy for mUC patients is platinum-based chemotherapy, most commonly cisplatin. For patients that progress during or after platinum-based chemotherapy, anti-PD(L)1 therapy can be used, showing durable responses in a subset…
Primary objectives:- To assess the efficacy of durvalumab monotherapy compared to placebo in terms of PFS- To assess the efficacy of durvalumab monotherapy compared to placebo in terms of OS