14 results
Primary objective *To evaluate the efficacy of 2 dose combinations of solifenacin and mirabegron compared to solifenacin and mirabegron monotherapySecondary objectives*To evaluate the efficacy of 2 dose combinations of solifenacin and mirabegron…
Primary Objective is to evaluate the efficacy of solifenacin 5mg in combination with mirabegron 50mg (referred to as combination therapy from here on) versus solifenacin 5mg monotherapy.Secondary Objectives are:- To evaluate the safety and…
The aim of the proposed study is to investigate the effect of a *3-receptor agonist on BAT activity (MRI analysis) and energy expenditure (indirect calorimetry), in South Asian as compared to white Caucasian individuals.
Primary objective:* To evaluate the safety and tolerability of long-term combination treatment with solifenacin (5 mg)with mirabegron (50 mg) compared to solifenacin and mirabegron monotherapySecondary objectives:* To evaluate efficacy of long-term…
To demonstrate the additive IOP lowering effect of SIMBRINZA (dosed BID) when added to DUOTRAV solution in subjects with open-angle glaucoma or ocular hypertension.
Primary Objective:* To evaluate ORR of avelumab in combination with talazoparib, in patients with locally advanced or metastatic solid tumors harboring BRCA1, BRCA2 or ATM defect.Secondary Objective:* To assess the overall safety and tolerability of…
Primary Objective:• Safety and tolerability of VXM01 in combination with avelumabSecondary Objectives:• Efficacy of VXM01 in combination with avelumab by assessment of tumor objective response rate (ORR) per Immunotherapy Response Assessment in…
The purpose of this study is to evaluate the safety and preliminary efficacy of avelumab in combination with M9241in subjects with metastatic or locally advanced unresectable solid tumors. This dose escalation study will establish a safe dose of…
Primary:To assess the effect of bilateral treatment with AAV5-hRKp.RPGR on functional vision as measured by vision-guided mobility assessment.Secondary:To assess changes after treatment administration in retinal function, functional vision, visual…
Main objective:To assess the long-term safety and tolerability of AAV5-hRKp.RPGR in individuals with RPGR-XLRPTo assess the long-term efficacy of treatment with AAV5-hRKp.RPGR in individuals with RPGR-XLRP based on assessments of functional vision…
To demonstrate benefit of maintenance treatment with avelumab for a maximum of six months avelumab in increasing overall survival (OS) at 18 months in the whole study population of patients with unresectable locally advanced or metastatic UC who…
To demonstrate the benefit of sequential chemo-immunotherapy in increasing the proportion of patients reaching a pathological complete response (pCR) at radical surgery in patients with locally advanced irresectable, stage cT4bNxM0, or clinically…
The evaluation of R-IrAE's after ICI therapy, specifically incidence, treament of R-IrAE's, response to said treatment, baseline and follow-up serology (general and symptom specific) to be combined with quality of life assessment and…
Primary Objectives- Cohort 1 Part 1: To determine the KRT-232 recommended phase 2 dose (RP2D)- Cohort 1 Part 2: To determine the objective response rate (ORR) in subjects with p53WT MCC who have failed anti-PD-1 or anti-PD-L1 immunotherapy- Cohort 2…