21 results
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 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).
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).
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:…
1. To assess safety of different doses of a single iv injection of SGM-1012. To assess the performance of SGM-101 in the intraoperative detection of colorectal or pancreas cancer by:a. Tumor-to-background ratio (TBR);b. Concordance between…
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…
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: · 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 main objective is to investigate the feasibility of a tumour-targeted fluorescent tracer SGM-101, combined with the use of the CE-marked fluorescence-laparoscope of Quest Medical Imaging, to discriminate between normal, LGD and malignant tissue…
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…
We hypothesize that the timing of treatment in IA, also known as chronotherapy, matters and that the efficacy of tofacitinib XR depends on it.Therefore, the aims of this randomized controlled trial are: 1. To compare the clinical effectiveness of…
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.…
1. To determine the feasibility of SGM-101 for intraoperative imaging of colorectal lung metastases - Concordance between fluorescent signal and tumor status of resected tissue2. To define the optimal dose of SGM-101 for intraoperative imaging of…
The primary objective of this clinical trial is to assess the performance of SGM-101 in theintraoperative detection of resection margins and metastases in patients undergoing curativesurgery for colorectal cancer. SGM-101 will be administered as a…
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…
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…
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…
This study evaluates the yield of NIR-Fluorescence imaging as additional surgical-tool for visualization and assessment of local extent and resectability status of neoadjuvant treated localized pancreatic tumors, local lymph node-involvement as well…
1. To determine the feasibility of SGM-101 for intraoperative imaging of colorectal brain metastases - Concordance between fluorescent signal and tumor status of resected tissue- Concordance between the fluorescent signal and the resection margin…