20 results
Primary objectives:* Progression-free survival (PFS) defined as either of the following occurrences, whichever comes first:o PSA progression o Progressive disease according to RECIST when measurable diseaseSecondary objectives:* Toxicity profile.*…
The primary objective is to evaluate progression free survival (PFS) of ofatumumab maintenance treatment versus no further treatment after remission induction in subjects with relapsed CLL.Secondary objectives are to evaluate clinical benefit,…
To determine the efficacy of two dose regimens of HuMax-CD20 in patients with Follicular Lymphoma who are refractory to rituximab in combination with chemotherapy or to rituximab given as maintenance treatment.
Primary: To evaluate the efficacy and safety of HuMax-CD20 in patients with B-cell Chronic Lymphocytic Leukemia (B-CLL) who have failed fludarabine and alemtuzumabSecondary: To determine the host immune response to HuMax-CD20To determine the…
To demonstrate that ofatumumab is superior to teriflunomide in reducing the frequency of confirmed relapses as evaluated by the annualized relapse rate (ARR) in patients with relapsing MS
Primary: To determine whether ofatumumab 3, 30 or 60 milligrams (mg) given subcutaneously (SQ), reduces the cumulative number of new T1 GdE brain lesions over a period of 12 weeks, as compared with placebo.Secondary: Cumulative number of new T1 GdE…
The aim of this study is to evaluate the efficacy of a personalized drug profiling method using short-term cultures of malignant cells derived from the patient*s pleural fluid.
Parts A and B:To evaluate the efficacy of efgartigimod PH20 SC on achieving sustained remission in the treatment of participants with bullous pemphigoid (BP)
Primary: to characterize the safety and tolerability of GSK3052230 in combination with chemotherapy regimens, to determine the MTD and to assess overall response rate in patients with stage IV or recurrent squamous NSCLC with FGFR1 gene…
Primary:To determine the safety and tolerability and to establish a preliminary recommended Phase 2 dose (RP2D) of MK-5890 when used as monotherapy and in combination with pembrolizumab in the dose escalation and confirmation phase and the dose…
Primary Objective:- Efficacy of ARGX-113 as assessed by the percentage of "Myasthenia Gravis Activities of Daily Living (MG-ADL) responders" in the acetylcholine receptor (AChR)- antibody (Ab) seropositive population.Secondary Objectives:1…
The aim of this trial is to investigate the long-term safety, tolerability, and immunogenicity of efgartigimod administered intravenously (IV) in pediatric participants rolling over from the ARGX-113-2006 trial and to ensure access to the drug…
Primary objectivesTo compare overall survival for MK-7684A in combination with the background therapy of etoposide/platinum followed by MK-7684A to atezolizumab in combination with the background therapy of etoposide/platinum followed by…
Primary objective:- To assess the clinical efficacy of efgartigimod IV 10mg/kg administered in a q2w continuous regimen compared to that administered in a cyclic regimen.Secondary objectives:- To evaluate the safety and tolerability of both…
To evaluate efficacy of image-guided de-escalating chemotherapy in the presence of dual HER2-blockade with Herceptin® and pertuzumab in HER2-positive breast cancer, as measured by three-year event-free survival.Secondary objectives• To evaluate 3-…
Primary objectives (Dose-escalation Phase):• To evaluate the safety and tolerability, describe the dose-limiting toxicities (DLTs), to determine the maximum tolerated dose (MTD), optimal biological dose (OBD), or highest protocol-defined dose (HPDD…
To confirm an age-adjusted optimum dose of efgartigimod IV and provide (model-predicted) evidence for a treatment response.
This study is designed to collect long-term safety, tolerability, effectiveness and health outcomes data in RMS patients.COVID-19 substudy:The purpose of this COVID-19 research sub-study is to determine the effects of the study treatment (ofatumumab…
Main objective:- To evaluate the long-term safety and tolerability of ARGX-113 in acetylcholine receptor antibody (AChR-Ab) seropositive patients.Secondary objective:- To evaluate the long-term safety and tolerability of ARGX-113 in the overall…
To assess the long-term safety and tolerability of treatment with efgartigimod PH20 SC in participants with BP