19 results
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 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 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…
The primary objective of this study is to assess the pharmacokinetics (PK), pharmacodynamics (PD), safety, andefficacy of ALXN1210 in pediatric patients with paroxysmal nocturnal hemoglobinuria (PNH).
The objective is to study the feasibility of different PET tracers to detect vulnerable plaques in patients with a recent acute coronary syndrome and co-localize these inflammatory lesions with anatomical plaque features obtained with CT based…
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…
PrimaryTo assess the efficacy of ravulizumab in the treatment of participants with TMASecondaryTo characterize TMA responseTo assess impact on hemoglobin levels To evaluate change in kidney function To assess duration of Complete TMA Response and…
The aim of this study is to determine whether LNP023 is effective and safe for the treatment of PNH. LNP023 is compared to the Standard of Care (SOC) anti-C5 antibody treatment. The primary objectives are to:• Demonstrate superiority of LNP023…
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).
Part 1 - To determine the efficacy of oral BCX9930 monotherapy administered for 24 weeks, compared to continued complement component 5 (C5) inhibitor therapy, in subjects with paroxysmal nocturnal hemoglobinuria (PNH) with an inadequate response to…
To assess the efficacy of ravulizumab versus placebo in the treatment of adult and adolescent participants with HSCT-TMA.
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…
To evaluate the efficacy of ravulizumab compared with placebo to reduceproteinuria in adult participants with LN or IgAN.
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…
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)
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…
Main objective:To assess the efficacy of ravulizumab compared with placebo in the treatment of gMG based on the improvement in the Myasthenia Gravis-Activities of Daily Living (MG-ADL) profile.Secondary objectives:• To assess the efficacy of…
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 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…