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…
A new formulation of DuoTrav® eye drops, called DuoTrav APS, in which, the preservative (BAC) has been replaced by a new preservative called POLYQUAD has been developed. POLYQUAD is expected to be better tolerated in the eye, especially for the…
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 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…
This study has been transitioned to CTIS with ID 2023-507342-84-00 check the CTIS register for the current data. (1) Main objective:Safety Run-In (SRI):To assess the safety and tolerability of durvalumab + tremelimumab + EV in participants with MIBC…
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…