17 results
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…
The objectives of this open-label extension safety monitoring (OLE-SM) study are as follows:Part 1 (Open-Label Extension; OLE)• To assess the long-term safety and efficacy of etrolizumab in patients eligible for Part 1 (OLE)Part 2 (Safety Monitoring…
The primary objectives for Part 1:-To determine the recommended Phase II dose of RO5424802 to be used in Part 2 of the study-To evaluate the safety and tolerability of 600mg and 900mg doses of RO5424802 administered twice daily to subjects with…
The primary objective of this study is to demonstrate efficacy of BIIB059compared with placebo in participants with active systemic lupuserythematosus (SLE), who are receiving background lupus standard ofcare (SOC) therapy in reducing disease…
Primary objective1. To evaluate efficacy of ILT-101 for the preservation of residual pancreatic β cells function2. To select the optimal regimen of administration of ILT-101.Secondary objectivesTo assess:1. Tregs expansion after an induction period…
The primary objective of this proof-of-concept study is to evaluate feasibility of 68Ga-tilmanocept PET/CT for SLN mapping in patients with stage I-II high/high-intermediate risk endometrial cancer. Secondary objectives are: - To investigate the…
The primary objectives of the study are- To evaluate the long-term safety and tolerability of evinacumab 15 mg/kg intravenous (IV) administered every 4 weeks (Q4W) in patients with homozygous familial hypercholesterolemia (HoFH).- To evaluate the…
The primary objective of this study is to assess the efficacy of a single intratympanic injection of AC102 compared to oral steroids in patients with moderately-severe to profound ISSNHL. After treatment of patients, the efficacy will be evaluated…
The purpose of this study is to demonstrate improvement in Disease-Free Survival (DFS) with xevinapant compared to placebo when added to RT irrespective of subsequent anticancer therapy.
OBJECTIVES - Phase 2 (not to be conducted in NL):Phase 2 Primary Objective:- Identify a setrusumab dosing strategy in subjects with OI Phase 2 Secondary Objectives:- Evaluate the PK of setrusumab doses in subjects with OI- Determine the PD effects…
Compare the clinical efficacy of Epcoritamab to SOC (R-GemOx or BR)
The purpose of this study is to assess whether a new combination treatment (Savolitinib and Durvalumab) is better than standard treatment sunitinib in MET-driven PRCC. The study will also assess the contribution of one part of the combination (…
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:• To evaluate the safety of ORGN001 (formerly ALXN1101) over the first 6 months of treatmentSecondary:• To characterize the pharmacokinetics (PK) of increasing doses of ORGN001 (formerly ALXN1101) • To evaluate the effect of ORGN001 (…
Primary:To determine the efficacy (as defined by progression-free survival [PFS]) of nirogacestat in adult participants with progressing DT/AF.Secondary:To evaluate the safety and tolerability of nirogacestat in adult participants with progressing…
Objective Endpoint• To assess the clinical safety and tolerability of leniolisib in pediatric patients (aged 4 to 11 years) with APDS• Incidence of treatment-emergent AEs (TEAEs), SAEs, and AEs leading to discontinuation of study drug• Change from…
-To assess the safety and tolerability of CLDN6 CAR-T +/- CLDN6 RNALPX and to assess the comparability of CLDN6 CAR-T from the manualand automated processes-To identify the maximum tolerated dose (MTD)/RP2D for each IMP (i.e. CLDN6 CAR-T +/- CLDN6…