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Adjuvant immunotherapy with anti-PD-1 monoclonal antibody Pembrolizumab (MK-3475) versus placebo after complete resection of high-risk Stage III melanoma: A randomized, double-blind Phase 3 trial of the EORTC Melanoma Group.

This study has been transitioned to CTIS with ID 2023-509136-25-00 check the CTIS register for the current data. To prospectively assess whether post-operative adjuvant therapy with pembrolizumab improves recurrence-free survival (RFS) as compared…

A multicenter, randomized, double-blind, parallel group, placebo-controlled study to evaluate the efficacy and safety of iptacopan (LNP023) in complement 3 glomerulopathy

This study has been transitioned to CTIS with ID 2023-509331-83-00 check the CTIS register for the current data. Primary objective adults:To demonstrate the superiority of iptacopan (200 mg b.i.d.) compared to placebo in reducing proteinuria at 6…

A Phase 3 Randomized Study Comparing Bortezomib, Lenalidomide and Dexamethasone (VRd) followed by Ciltacabtagene Autoleucel, a Chimeric Antigen Receptor T cell (CAR-T) Therapy Directed Against BCMA versus Bortezomib, Lenalidomide, and Dexamethasone (VRd) followed by Lenalidomide and Dexamethasone (Rd) Therapy in Participants with Newly Diagnosed Multiple Myeloma for Whom Hematopoietic Stem Cell Transplant is Not Planned as Initial Therapy

This study has been transitioned to CTIS with ID 2023-505850-16-00 check the CTIS register for the current data. To compare the efficacy of VRd followed by cilta-cel therapy versus VRd followed by Rd therapy in terms of progression free survival (…

A Phase I/II, Single-Arm, Open-label Study to Evaluate the Pharmacokinetics, Safety/Tolerability and Efficacy of the Selumetinib Granule Formulation in Children Aged >= 1 to < 7 Years with Neurofibromatosis Type 1 (NF1) Related Symptomatic, Inoperable Plexiform Neurofibromas (PN) (SPRINKLE)

Primary objectives:- To determine the PK of selumetinib after administration of the selumetinib granule formulation. - To assess the safety and tolerability of the selumetinib granule formulation.

Sarcomas and DDR-Inhibition; a neoadjuvant phase I combined modality study - SADDRIN-1

This study has been transitioned to CTIS with ID 2024-514907-32-00 check the CTIS register for the current data. To assess the safety and tolerability profile, in the pre- and perioperative period (up to 30 days post-surgery), of combined modality…

Post-COVID Complaints in children Study (POCOS)

We aim to describe the clinical characteristics and immune response in children seeking care for post-COVID complaints. Moreover, in a subset of children we evaluate the effect of the reinfection on clinical and inflammatory outcomes in children…

A Phase 1b/2, Open-Label Study Evaluating the Safety and Efficacy of KRT-232 in Patients with p53 Wild-Type (p53WT)M erkel Cell Carcinoma (MCC) Who Have Failed Anti-PD-1 or Anti-PD-L1 Immunotherapy, or in Combination with Avelumab in MCC Patients Who Are Anti-PD-1 or Anti-PD-L1 Treatment Naïve

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…

Low dose cisplatin weekly versus high dose cisplatin every three weeks in primary chemoradiation in sarcopenic head and neck cancer patients.

This study has been transitioned to CTIS with ID 2024-514919-10-00 check the CTIS register for the current data. To investigate if the use of weekly low dose cisplatin increases compliance to the planned chemotherapy scheme in LA-HNSCC patients with…

PeRcutaneous cOronary intervention before Transcatheter Aortic Valve Implantation trial

Aim of the proposed project will be to evaluate in a large and prospectiverandomized way the safety and cost-effectiveness of performing TAVI without full revascularization of major coronary arteries before the valve replacement.

Telemonitoring for Asthma and COPD through voice analysis; the TACTICAS study

The goal of the TACTICAS study is to evaluate if acoustic speech characteristics in patients with asthma or COPD correlate with daily dyspnoea symptoms.

Improvement of glenoid component positioning using patient specific instrumentation in reverse shoulder arthroplasty

The primary objective is to compare the accuracy of the five-dimensional (5D) calibrator device for glenoid positioning with the accuracy of the conventional (freehand) method.

An open label, multicenter roll-over extension program (REP) to characterize the long-term safety and tolerability of iptacopan (LNP023) in patients with Paroxysmal Nocturnal Hemoglobinuria (PNH) who have completed PNH Phase II and Phase III studies with iptacopan

This study has been transitioned to CTIS with ID 2023-509843-28-00 check the CTIS register for the current data. The purpose of this study is to evaluate the long-term safety, tolerability and efficacy of iptacopan in patients with PNH and to…

A Phase 3 Randomized, Double-Blind, Placebo-Controlled Study of Adeno-Associated Virus Serotype 8-Mediated Gene Transfer of Glucose-6-Phosphatase in Patients with Glycogen Storage Disease Type Ia

This study has been transitioned to CTIS with ID 2023-508750-25-00 check the CTIS register for the current data. Primary: To evaluate the efficacy of DTX401 to reduce or eliminate dependence on exogenous glucose replacement therapy needed to…

A Phase 1 and 2a open-label trial to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, immunogenicity, and antitumor activity of LAVA-1207, a PSMA-targeting bispecific &gamma;&delta;-T cell engager, alone or with low dose interleukin-2 or Pembrolizumab, in patients with therapy refractory metastatic castration resistant prostate cancer

This study has been transitioned to CTIS with ID 2024-515821-27-00 check the CTIS register for the current data. Primary objectivesPart 1 Dose Escalation for LAVA-1207 alone, LAVA-1207 plus LDSC IL-2, and LAVA-1207 plus pembrolizumab• To investigate…

The effect of walking with and without music on executive functions and gait in children aged 8 to16 years old and adults over 40 years old with mild cerebral palsy

The main objective of this study is to investigate the acute beneficial effect of moderate inten-sive exercise (defined as walking) on neurocognitive functioning in healthy children and adults with mild CP, GMFCS I and II and if this effect is…

A Phase 1/2, Open-label, Dose-Escalation and Dose-Expansion Cohort Study of SNDX-5613 in Patients with Relapsed/Refractory Leukemias, Including Those Harboring an MLL/KMT2A Gene Rearrangement or Nucleophosmin 1 (NPM1) Mutation

This study has been transitioned to CTIS with ID 2024-513759-34-00 check the CTIS register for the current data. Primary ObjectivesPhase 2The primary objectives of Phase 2 are:• To evaluate short- and long-term safety and tolerability of SNDX 5613…

Dolphin CONTINUE: A nutritional intervention aimed at improving neurodevelopmental outcome in infants at risk for or with early life brain injury

The main objective is to study the effect of the nutritional intervention versus the control product on white matter development (as assessed using tract based spatial statistics of fractional anisotropy) using a DTI scan at the corrected age of…

A prospective randomized study to compare neurocognitive outcome after Stereotactic Radiosurgery or Whole Brain Radiation Therapy for the treatment of multiple brain metastases

Primary Objective Our primary aim is to compare cognitive decline at 3 months, defined as a significant decline (5 point decrease from baseline based on the reliable change index with correction for practice effects) in HVLT-R Total Recall score (…

Safe and easy application of BioComp implants for episthetic reconstruction of craniofacial defects - A pilot study

In this study we want to investigate the efficacy and safety of an implant system with a surface coating (Biocomp) for episthetic reconstruction after ablative surgery in the nasal, orbital and auricular region

N15DOP: Phase I and pharmacological study of weekly ModraDoc006/r in combination with high-dose intensity-modulated radiation therapy in patients with high-risk early stage prostate cancer

To determine the maximum tolerated dose (MTD) of ModraDoc006/r (as ModraDoc006 10 mg tablets in combination with one tablet of 100 mg ritonavir) that can safely be administered in a bi-daily weekly schedule in combination with high-dose intensity…