19 results
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.
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 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…
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.
The main objectives for this study are: - To assess the safety and tolerability of the combination of pembrolizumab and lenvatinib and belzutifan.- To evaluate the confirmed objective response rate (ORR) per RECIST 1.1 as assessed by blinded…
To compare pembrolizumab plus lenvatinib in combination with TACE versus placebo plus TACE with regard to progression-free survival (PFS) per RECIST 1.1 assessed by blinded, independent central review (BICR)
PEMbrolizumab Plus Lenvatinib In Second Line And Third Line Malignant Pleural MEsotheLiomA Patients.
Primary: 1. To determine the objective response rate (ORR), defined by Modified (i)RECIST criteria for pleural mesothelioma, of the combination of pembrolizumab - lenvatinib in pre-treated patients with MPM. Secondary:1. To describe the safety of…
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).
1. Primary Objectives• To evaluate the safety and tolerability of VX 440 monotherapy and VX 440 in dual and triple combination with VX-661 and IVA• To evaluate the efficacy of VX 440 monotherapy and VX 440 in dual and triple combination with VX 661…
The purpose of this study is to investigate the safety and tolerability of the new compound PB006 (natalizumab) when it is administered to healthy volunteers. PB006 has not been administered to humans before. It has been previously tested in the…
The primary objective is to assess long-term safety of study drug(s) in subjects who are enrolled in Eisai-sponsored lenvatinib studies.
Primary ObjectiveTo evaluate whether lenvatinib in combination with ifosfamide and etoposide (Arm A) is superior to ifosfamide and etoposide (Arm B) in improving progression-free survival (PFS) by independent imaging review [IIR] using Response…
1) Objective: To evaluate the safety and tolerability of the pembrolizumab combination therapy.2) Objective: To estimate PSA response rate of the pembrolizumab combination therapy. PSA response is defined as a reduction in the PSA level of 50% or…
Objective 1: To compare MK-7684A to pembrolizumab alone with respect to ORR in participants with cervical cancer whose tumors express PD-L1 (CPS >=1)Objective 2: To compare MK-7684A to pembrolizumab alone with respect to PFS in participants…
Primary ObjectiveTo assess whether a starting dose of lenvatinib 14 mg in combination with everolimus 5 mg once daily (QD) will provide comparable efficacy (based on objective response rate [ORR] at 24 weeks [ORR24W]) with an improved safety profile…
Primary objectives:# Safety Lead-in Phase: To assess the safety and tolerability, and to establish an RP2D if applicable, of treatment combinations that have not been evaluated in a separate study.# Efficacy Phase: To assess the safety and…
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…
To compare belzutifan+lenvatinib to cabozantinib with respect to PFS per Response Criteria in Solid Tumors (RECIST) 1.1 as assessedby blinded independent central review (BICR).
Primary objectives:# Safety Lead-in Phase: To assess the safety and tolerability, and to establish an RP2D if applicable, of treatment combinations that have not been evaluated in a separate study.# Efficacy Phase: To assess the safety and…