10 results
Objectives:Primary Objectives:1. To evaluate the efficacy of BAN2401 compared to placebo by establishing the ED90 (as defined in theprotocol) for BAN2401 on the derived Composite Clinical Score at 12 months of treatment in subjects withEarly…
Primary:* To determine the efficacy profile of PA101 delivered via a high efficiency nebulizer (eFlow®,PARI) in comparison with placebo following 6 weeks of treatment in patients with indolentsystemic mastocytosis (ISM) who are symptomatic despite…
Primary objectives: Dose-expansion:To evaluate the antitumor activity of MEDI0680 in combination with durvalumab versus nivolumab monotherapy in immunotherapy-naïve subjects with advanced or metastatic ccRCC as based on investigator assessed…
The objectives of the study are as follows:Primary:• Part 1: To assess the pharmacokinetics and relative bioavailability of three different formulations of PA101 (4% cromolyn sodium with and without mannitol, and 6% cromolyn sodium without mannitol…
In the proposed project, we will conduct a clinical phase I trial with cervical cancer patients, scheduled to undergo radical hysterectomy and pelvic lymphadenectomy, to assess the safety and toxicity as primary endpoints and, as an explorative…
The aim of the study is to develop PD-L1 PET/CT imaging in patients with advanced HNSCC to non-invasively image PD-L1 expression in tumours and to determine the correlation with response to durvalumab. The studie will be divided into 2 parts:1:…
The primary objective of this study is to assess the efficacy of MEDI4736 treatment compared with placebo in terms of overall survival (OS) and progression free survival (PFS; (per RECIST 1.1 as assessed by the investigator).
Primary Objective: To monitor long-term safety of durvalumab (allcohorts)Secondary Objectives: To assess the efficacy of durvalumab in terms of ORR and DOR in patients who undergoretreatment with durvalumab (Cohort 2 only)Secondary ObjectivesTo…
To assess the effect of MEDI4736 in combination with olaparib±bevacizumab in patients with selected advanced solid tumors.To assess the safety and tolerability of MEDI4736 in combination with olaparib (±bevacizumab) in patients with selected…
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…