8 results
The aim of the study is twofold. The first is the impact of the investigational drugs and the registered product on safety, tolerability and the release of vessels studied and compared. The second is the speed with which the investigational drugs…
Primary: To evaluate the long-term safety and tolerability of BIIB017 in subjects originally treated in Study 105MS301 who continue BIIB017 treatment.Secondary: To describe long-term MS outcomes in subjects originally treated in Study 105MS301 who…
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…
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…
(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…
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…
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…