19 results
The primary objective of this study is to evaluate the efficacy (clinical and MRI) of switching tonatalizumab compared to receiving interferon β1-a or glatiramer acetate.
EFFICACY OBJECTIVESWithin each cohort, the study has the following co-primary efficacy objectives:· Assessing early efficacy during the Maintenance Treatment Phase based on a 20%reduction in tumour size after 2 months of treatment· Evaluating PFSThe…
Improvement in OS is generally accepted as the best measure of clinical benefit forpatients with advanced/unresectable or metastatic NSCLC. The assumption thattreatment with MPDL3280A will prolong OS compared with treatment with docetaxel isbased on…
Our main objective is to prove that extending dose intervals guided by serum concentrations of natalizumab, will not result in radiological or clinical disease activity.
The main objective of the study is to investigate whether the strong clinical effects of natalizumab in RRMS can be explained by enhanced functional adaptation mechanisms of the brain and whether enhanced functional reorganisation is sustained over…
Part 1:The primary objective of the study is to investigate whether treatment with natalizumab slows the accumulation of disability not related to relapses in subjects with SPMS. The secondary objectives of this study are to determine in this study…
The objective of the present study is to assess the effect of HTL0009936 on cognitive performance in elderly subjects with below average cognitive function. The oral pharmacokinetics of HTL0009936 shows a significant degree of variability between…
Natalizumab (Tysabri®) for the treatment of anti-Hu associated paraneoplastic neurological syndromes
The primary objective of the study is the functional improvement with one point or more on the modified Rankin scale after the 12th week of natalizumab (compared to baseline).
AssessinG Efficacy of carboplatin and ATezOlizumab in metastatic Lobular breast cancer: GELATO-trial
To assess the efficacy of atezolizumab in combination with carboplatin in metastatic ILC
Primary objective: To evaluate the efficacy of MPDL3280A in patients with locally advanced or metastatic solid tumor whom, in the opinion of the investigator, based on available clinical data, may benefit from treatment with anti PD-L1 immunotherapy…
To determine a safe dose combination of carboplatin-cyclophosphamide combined with atezolizumab fixed dose in advanced breast cancer and gynaecologic cancer (ovarian, cervical and endometrial cancer).
Primary Objective:- To provide continued access to atezolizumab based therapy and/or comparator agent(s) for eligible patients still on study treatment at the time of the parent study closure.Secondary Objectives:- Safety Objective: To evaluate the…
*- To explore efficacy of neoadjuvant atezolizumab and bevacizumab following radiotherapy in low- to intermediate-risk rectal cancer• To evaluate safety/tolerability and pre-operative treatment-related complications with atezolizumab and bevacizumab…
Primary Objective: Our objective is to validate the safety, measured by radiological disease activity, of personalized extended interval dosing of natalizumab to >=6 weeks (with an aim natalizumab trough concentration of 5 µg/ml) in a large…
Primary Efficacy ObjectiveThe primary efficacy objective of the study is as follows:• To evaluate the efficacy of 16 cycles of atezolizumab treatment compared with best supportive care as measured by disease-free survival (DFS) as assessed by the…
The sponsor is developing a compound (PB006) similar to Tysabri® (natalizumab, hereafter referred to as Tysabri). As part of medical-scientific studies to confirm the similarity of the two compounds, the Sponsor wants to compare PB006 with EU-…
The co-primary objectives of this study are: * To evaluate the efficacy of as measured by investigator-assessed PFS according to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1). * To evaluate the efficacy of atezolizumab as…
Primary objective: To explore the safety and feasibility of neoadjuvant capecitabine, oxaliplatin, docetaxel, and atezolizumab in GE-junction and gastric adenocarcinoma Secondary objectives: • To assess pathological tumor regression and rates of…
Primary objectives: The first primary objective is to study the expression of PD-L1 in normal tissue and lymphoma lesions before CAR T-cell therapy in LBCL patients by 89Zr-atezolizumab PET/CT imaging and to correlate the pretreatment 89Zr-…