22 results
Primary Objectives:* To compare overall survival (OS) of patients who receive NKTR-102given once every 21 days (q21d) to patients who receive Treatment ofPhysician*s Choice (TPC) selected from the following list of seven singleagentintravenous…
Primary: efficacy of belimumab for the treatment of IMN.Secondary: safety and tolerability, PK, PD, quality of life, benefit of earlier treatment initiation.
The primary aim of the study is to investigate whether it is possible to select patients by PET in a good prognosis group (i.e. low SUV) who will not benefit from adjuvant chemotherapy.
To investigate the efficacy and safety of BIBW 2992 in combination with vinorelbine iv chemotherapy as treatment in patients with HER2-overexpressing, metastatic breastcancer, who failed one prior trastuzumab treatment.
The objective of the study (phase 2) is to evaluate the effectiveness of AMG 102 in combination with Mitoxantrone and Prednisone in previously treated subjects with castrate resistant prostate cancer.
The main purpose of this study is to assess whether the study drug anetumab ravtansine is more effective than treatment with vinorelbine in patients with stage IV, mesothelin overexpressing malignant pleural mesothelioma. Efficacy will be measured…
Primary: safety and tolerability of belimumab in a pediatric population (5-17 y) with SLE.Secondary: PK, efficacy, quality of life.
Primary objective: To compare progression-free survival (PFS) as assessed by blinded, central review between patients randomized to niraparib versus physician*s choice. Key secondary objective: To compare overall survival between patients randomized…
The purpose of this study is to test the safety, tolerability and anti-tumor activity of the research study drug, Pembrolizumab (MK-3475) compared to other chemotherapy drugs of physician*s choice (which includes Capecitabine, Eribulin, Gemcitabine…
This study is a Phase III, randomised, open label, multi-centre study assessing the efficacy and safety of MEDI4736 versus Standard of Care in NSCLC patients with PD-L1-positive tumours and the combination of MEDI4736 plus tremelimumab (MEDI4736+…
Quizartinib selectively inhibits survival pathways that block apoptosis by inhibiting FLT3. Quizartinib inhibits proliferation of FLT3-dependent cell lines, and is effective in human leukemia tumor xenograft models of AML. Data from the Phase 1 and…
Primary objectivesThe primary objective of this trial is to evaluate the efficacy in terms of overall survival (OS) at 24 months of a chemotherapy-free dual HER2-inbibition with trastuzumab and pertuzumab (first-line) followed by T-DM1 (second-line…
* To evaluate the efficacy of belimumab in combination with standard of care in adult subjects with lupus nephritis Class III, IV, or V using the 2003 ISN/RPS criteria. * To assess the safety and tolerability of belimumab plus standard of care…
The primary objective is to assess whether combination treatment BLM+RTX will lead to reduced treatment failure and the improvement of pivotal, SLE-specific autoimmune phenomena compared SLE patients treated with standard of care.
Primary Objective: Phase I dose escalationThe main objective of the phase I part is to determine safety and the recommended phase II dose (RP2D) of the triple combination.Phase IIThe main objective of the phase II part is to determine efficacy of…
Primary objective:To evaluate the anti-leukemic activity of isatuximab in combination with standard chemotherapies in pediatric participants of ages 28 days to less than 18 years with Relapsed/Refractory Acute Lymphoblastic Leukemia (ALL) or Acute…
The primary objective of the study is to evaluate the progression free survival of patients when these are treated with ramucirumab and cyclophosphamide and vinorelbine, in comparison to treatment without ramucirumab.The secondary objectives of the…
The primary objective is to characterize the PK profile of belimumab 200 mg SC in pediatric SLE participants.The secondary objectives are to evaluate the safety and tolerability of belimumab 200 mg SC in pediatric SLE participants and to…
The primary goal of this study is to investigate the effects of belimumab on the composition of lymph nodes and the inflamed synovial tissue as well as (subsets of) immune cells in the peripheral blood. In addition, we will identify immunological…
Primary:To evaluate the efficacy of belimumab and a single cycle of rituximab administered in a combination regimen to adult participants with SLE. Secondary:Other aspects of efficacy. Safety and tolerability. Questionnaires.