142 results
To assess the number of patients in remission, 12 months after dose adjustment of IFX from 5mg/kg to 3 mg/kg. Secondary objectives include: number of relapses, defined by increase of fecal calprotectin and/or CRP and clinical activity, subsequently…
Currently, there is no guideline for the treatment of perianal Crohn's fistulas. the aim of this study, in which surgical strategies (seton drainage and surgical closure with advancement plasty/LIFT) will be compared to medical treatment. We…
Patients with ALS are routinely prescribed riluzole, the only registered drug for the treatment of ALS. This study will evaluate the concentration-effect relationship of riluzole (100 mg) and retigabine (300 mg) on axonal excitability measures. In…
The objective of this study is to compare the efficacy of Infliximab-biosimilar to Infliximab-innovator and to demonstrate its noninferiority up to 30 weeks, in patients with ulcerative colitis or Crohn*s disease in remission under treatment with…
Primary Objectives(1) To evaluate the overall survival (OS) of subjects with metastatic or locally advanced/unresectable urothelial cancer that has recurred or progressed following platinum-based chemotherapy (recurrent/progressive metastatic…
Primary objectives:(1) To determine the safety and tolerability of pembrolizumab. (2) To evaluate the Overall Response Rate (ORR) of pembrolizumab by independent central review according to the International Working Group (IWG) response criteria (…
The objective of this study is to test the safety, tolerability and anti-tumor activity of the combination of the investigational products epacadostat and pembrolizumab, compared to pembrolizumab as mono therapy, in patients with cisplatin-…
The objective of this study is to test the safety, tolerability and anti-tumor activity of the combination of the investigational products epacadostat and pembrolizumab, compared to pembrolizumab as mono therapy, in patients with advanced/…
The primary study objective of our study is to assess the efficacy of an IFX intensified induction scheme vs. a standard dosing schedule in improving drug exposure (=therapeutic trough levels) without treatment escalation in pediatric CD patients.
To identify potential biomarkers for early identification of clinical benefit during pembrolizumab treatment in patients with advanced urothelial cancer. To identify potential mechanisms of primary and acquired resistance to pembrolizumab.To assess…
Primary/dualco-primary. To prospectively investigate whether adjuvant treatment with pembrolizumab after completion of radical surgery (lobectomy/pneumonectomy) with or without standard adjuvant chemotherapy for stage IB (T >= 4 cm) -II-IIIA…
The primary objective of our study is to determine the efficacy and safety of top-down IFX treatment in moderate-to-severe pediatric CD. Secondary objectives are determination of the pharmacokinetic/-dynamic profile of IFX and finding predictors of…
Goal of this study is to determine the optimal balance between maintaining high rates of OS in this group and avoiding the long-term toxicity associated with therapy intensificiation. The addition of pembrolizumab to standard care is expected to…
The primary objective is to investigate the efficacy of IO102-IO103 in combination with pembrolizumab (compared with pembrolizumab alone) in terms of progression-free survival (PFS). The secondary objectives are to further explore the efficacy of…
Primary:To determine the safety, tolerability, MTD (maximum tolerated dose) or the MAD (maximum administered dose) of GSK3359609 in combination with pembrolizumab or chemotherapy with(out) pembrolizumab. Secondary:To determine the recommended dose…
1) To compare disease-free survival (DFS) as assessed by investigator for participants treated with belzutifan plus pembrolizumab versus those receiving placebo plus pembrolizumab
The aim of this study is to investigate the efficacy of subcutaneous IFX in the treatment of moderate to severe Crohn*s disease with and without concomitant immunosuppression, as measured by the proportion of patients in corticosteroid-free clinical…
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…
Primary objective:• Evaluate the anti-tumor activity of GEN1046 as monotherapy and in combination with pembrolizumab in subjects with relapsed/refractory metastatic NSCLCSecondary objectives:• Evaluate time to onset and durability of the anti tumor…
Phase I Dose Escalation1.To determine the RP2D in terms of safety and tolerability for:•IV admin of HB-201 in patients with HPV 16+ confirmed HNSCC•IT admin of HB-201 in patients with HPV 16+ confirmed cancers•IV admin of HB-202 in patients with HPV…