19 results
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…
Primary objective:To determine whether there is a difference in overall survival (OS) between lurbinectedin (PM01183)/doxorubicin (DOX) and a control armconsisting of best Investigator's choice between cyclophosphamide (CTX), doxorubicin (DOX)…
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 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:…
Main objective:The main objective is to evaluate the efficacy of two intensified consolidation strategies in very-high risk neuroblastoma (VHR-NBL) patients in terms of event-free survival from randomisation date. Thisevaluation will follow a…
Primary:- To test whether bevacizumab added to a backbone chemotherapy regimen (temozolomide or irinotecan-temozolomide or topotecan-temozolomide) demonstrates activity in children with relapsed or refractory neuroblastoma- To test whether the…
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: · To determine the efficacy of DARA plus durvalumab (DURVA) in subjects with RRMM who have progressed on DARA while on a DARA-containing regimen as the most recent MM treatment.Secondary:· Determine the safety of DARA plus DURVA in subjects…
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).
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…
Evaluate the antitumor activity of nemvaleukin alfa (*nemvaleukin*, ALKS 4230) in combination with pembrolizumab as compared with chemotherapy in patients with platinum-resistant ovarian cancerSecondary Objectives:Evaluate the antitumor activity of…
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…
Primary Objective:• To compare the progression-free survival (PFS) of patients randomized to mirvetuximab soravtansine (MIRV) vs. Investigator*s choice of chemotherapy (IC Chemo) Key Secondary Objectives:• To compare the objective response rate (ORR…
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…
This study will evaluate the safety, tolerability, and pharmacokinetics of idasanutlin as a single agent and the safety, tolerability, pharmacokinetics, and preliminary efficacy of idasanutlin in combination with either chemotherapy or venetoclax in…
The treatment options currently available for MIBC- patients remain limited, current standard therapy is likely to result in modest improvements in long-term survival, and additional and alternative therapies are required for patients with MIBC.…
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…
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…