32 results
Primary objectives:- To determine the maximum tolerated dose (MTD) of sunitinib when administered once a week or once every two weeks.- To assess the safety and tolerability of sunitinib in a once weekly or once every two weeks dose schedule- To…
The main objective of this pilot study is to determine PKI concentration in tumor tissue after approximately two weeks of treatment.
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 primary objective is to determine the effect of high-dose sunitinib versus standard treatment with lomustine on six-month progression-free survival (PFS6) in patients with recurrent GBM, using the RANO criteria. Secondary objectives are:1. To…
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…
The purpose of this study is to assess whether a new combination treatment (Savolitinib and Durvalumab) is better than standard treatment sunitinib in MET-driven PRCC. The study will also assess the contribution of one part of the combination (…
(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 primary objective is progression-free survival (PFS); defined as the time from randomization to the date of the first documented tumor progression; determined using Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria or death due…
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 co-primary endpoints of this study are PFS in intermediate and poor-risk subjects, as assessed by an Independent Radiology Review Committee (IRRC) and OS in intermediate and poor-risk subjects. The final analysis of PFS will occur after 583…
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…