51 results
The primary objective of this study is to assess the comparative safety and efficacy ofAztreonam Lysine for Inhalation (AZLI) and Tobramycin Nebuliser Solution (TNS) in adultand pediatric cystic fibrosis (CF) patients aged 6 years or older with…
The purpose of this study is to evaluate whether aztreonam solution for inhalation (AZLI) is safe and effective for the treatment and complete eradication of a lung infection with PA (Pseudomonas aeruginosa) in patients with Cystic Fibrosis (CF) and…
The aim of this study is to investigate what proportion of HBeAg negative, inactive carriers of the hepatitis B virus with low (< 20,000 IU/mL) load will lose HBsAg when treated with nucleot(s)ide analogue/Peg-IFN combination therapy.
The overall aim of this study is to demonstrate increase of tumor-infiltrating CD8+ T cells in non-small cell lung cancer during neo-adjuvant treatment with durvalumab (MEDI4736).
Main objective:Determine the recommended dose of durvalumab in combination withLEN +/- dex in subjects with NDMM.Secondary objectives:- Evaluate the safety and preliminary efficacy of durvalumab incombination with LEN +/- dex in subjects with NDMM-…
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…
Determine the efficacy and safety (using objective response rate) of tremelimumab in patients with advanced solid tumors (UBC, PDAC, TNBC).
To assess the safety and tolerability profile of durvalumab monotherapy, durvalumab + novel oncology therapy, durvalumab + chemotherapy, anddurvalumab + novel oncology therapy + chemotherapy combinations
Primary ObjectiveThe primary objective is to assess safety and tolerability, describe the dose limiting toxicities (DLTs), and determine the maximum tolerated dose (MTD) or the maximum administered dose (MAD; in the absence of exceeding the MTD) for…
To assess the efficacy of Durvalumab monotherapy compared to SoC in terms of OS in patients with PD-L1 high expression (*25%) advanced NSCLC with wild type EGFR and ALK
Primary Objective:Efficacy:· Evaluate the efficacy of subcutaneous (sc) azacitidine in combination with durvalumab as compared with subcutaneous azacitidine alone in the defined study population.Secondary Objectives:Safety:· Assess the safety and…
To assess the safety and biodistribution of 89Zr-MEDI4736 and its uptake in tumor and target irAE tissues.
Primary:• Compare progression-free survival (PFS) as assessed by the Independent Review Committee (IRC) per Response Evaluation Criteriain Solid Tumors (RECIST) Version (v) 1.1 in ociperlimab plus tislelizumab (Arm A) versus Durvalumab (Arm C) among…
Objectives (all are exploratory):• To measure and analyze 89Zr-Df-IAB22M2C uptake cluster of (CD8+ PET signal) at and between baseline and post-treatment in tumor lesions and reference normal tissues, including T-cell rich tissues, using PET imaging…
Primary objective:-To assess the efficacy of durvalumab plus olaparib combination therapy compared with durvalumab monotherapy in terms of PFS (Investigator-assessed)Secondary objectives:- To further assess the efficacy of durvalumab plus olaparib…
The study objectives and endpoints described below will be evaluated for the following treatment regimens:• Arm A: Nivolumab + CCRT followed by nivolumab + ipilimumab maintenance• Arm B: Nivolumab + CCRT followed by nivolumab maintenance• Arm C:…
The objective of this trial is to evaluate progression-free survival in synchronous oligometastatic NSCLC patients treated with induction immunotherapy, chemotherapy and SBRT to all metastases followed by definitive surgery or radiotherapy to the…
Primary Objective:- Number of participants with dose limiting toxicity - Number of participants with treatment-related adverse events - Number of participants with treatment-emergent adverse events- Number of participants with changes in vital signs…
To evaluate PFS in participants treated with cCRT plus M7824 followed by M7824 or cCRT plus placebo followed by 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…