8 results
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…
Main protocol:To assess the incidence, severity, nature, seriousness, intervention/treatment, outcome, and causality, including immune-relatedness, of adverse events of special interest (AESIs) in patients who are treated with durvalumab and…
The primary objective for this study is as follows:* To evaluate clinical benefit in terms of PFS, as assessed by an IRF, for GA101 when used incombination with bendamustine compared with bendamustine alone in patients with indolentNHL refractory to…
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…
This Phase 2b/3 double-blind, placebo-controlled study will evaluate the safety, tolerability, and effects of livoletide on food-related behaviors in patients with Prader-Willi Syndrome (PWS).
(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 +…
Dose-finding:-To determine the adult equivalent exposure/MTD/recommended Phase II pediatric dose of durvalumab monotherapy and durvalumab in combination with tremelimumab-To determine the safety profile of durvalumab monotherapy, or durvalumab in…
The primary objective of this proof of concept study will be to investigate whether the combined use of local tumor ablation/radiation plus immunomodulating drugs may induce a significant immune response in patient with incurable liver metastases…