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An Open-Label, Single-Arm, Phase 1/2 Study Evaluating the Safety and Efficacy of Ponatinib for the Treatment of Recurrent or Refractory Leukemias or Solid Tumors in Pediatric Participants.

This study has been transitioned to CTIS with ID 2023-509699-41-00 check the CTIS register for the current data. Primary objectives:Phase 1: To determine the MTD and/or RP2D of oral ponatinib administered QD in pediatric participants with selected…

A Multicenter Phase 1/2, Open-Label Study of DCC-3014 to Assess the Safety, Efficacy, Pharmacokinetics, and Pharmacodynamics in Patients with Advanced Tumors and Tenosynovial Giant Cell Tumor

This study has been transitioned to CTIS with ID 2024-514933-39-00 check the CTIS register for the current data. Primary Objectives:• To assess the safety and tolerability of DCC 3014.• To characterize the pharmacokinetic (PK) profile of DCC 3014.•…

Improvement of Outcome in Elderly Patients or Patients not eligible for high-dose chemotherapy with Aggressive Non-Hodgkin Lymphoma in first Relapse or Progression by adding Nivolumab to Gemcitabine, Oxaliplatin plus Rituximab in case of B-cell lymphoma (NIVEAU)

Main objectiveImprovement of 1-yr PFS by nivolumab plus (R)-GemOx followed by nivolumab consolidation instead of (R)-GemOx alone in patients withprogressed or relapsed aggressive NHLs not eligible neither for autologous nor allogeneic stem cell…

A Phase 3 Randomized Study Comparing JNJ-68284528, a Chimeric Antigen Receptor T cell (CAR-T) Therapy Directed Against BCMA, versus Pomalidomide, Bortezomib and Dexamethasone (PVd) or Daratumumab, Pomalidomide and Dexamethasone (DPd) in Subjects with Relapsed and Lenalidomide-Refractory Multiple Myeloma

This study has been transitioned to CTIS with ID 2023-506588-32-00 check the CTIS register for the current data. Primary objective: To compare the efficacy of JNJ-68284528 with standard therapy, either pomalidomide, bortezomib and dexamethasone (PVd…

An Open-Label Roll-Over Study to Evaluate the Long-Term Safety and Efficacy of DCR-PHXC Solution for Injection (subcutaneous use) in Patients with Primary Hyperoxaluria

This study has been transitioned to CTIS with ID 2024-512260-54-00 check the CTIS register for the current data. PrimaryTo evaluate the effect of DCR PHXC on estimated glomerular filtration rate (eGFR) in participants with PH1Secondary:To identify…

Optimizing Access Surgery In Senior hemodialysis patients

To compare surgical strategies for vascular access creation in elderly hemodialysis patients.

A Phase 1b Study of Subcutaneous Daratumumab Regimens in Combination with Bispecific T Cell Redirection Antibodies for the Treatment of Subjects with Multiple Myeloma

This study has been transitioned to CTIS with ID 2023-503468-17-00 check the CTIS register for the current data. Primary- Part 1: To identify recommended Phase 2 doses and schedules (RP2Ds) for each combination.- Part 2: To characterize the safety…

Phase 1/2 Dose Finding, Safety and Efficacy Study of Ibrutinib in Pediatric Subjects with Chronic Graft Versus Host Disease (cGVHD)

This study has been transitioned to CTIS with ID 2023-507330-24-00 check the CTIS register for the current data. Part A - Dose Finding/SafetyPrimary Objective:* To determine the recommended pediatric equivalent dose (RPED; based on pharmacokinetic […

Phase 2 Study of Talimogene Laherparepvec in Combination With Pembrolizumab in Subjects With Unresectable/Metastatic Stage IIIB-IVM1d Melanoma Who Have Progressed on Prior Anti PD-1 Based Therapy

Primary objective:To evaluate the efficacy of talimogene laherparepvec in combination with pembrolizumab as assessed by objective response rate (ORR) in subjects with unresectable/metastatic stage IIIB-IVM1d melanoma who have progressed on prior…

A Pivotal Phase 3 Trial to Evaluate the Safety and Efficacy of Clazakizumab for the Treatment of Chronic Active Antibody-Mediated Rejection in Kidney Transplant Recipients

Primary Objectives 1. To evaluate the efficacy of clazakizumab in preventing all-cause composite allograft loss (including death) due to CABMR.2. To evaluate the efficacy of clazakizumab in slowing/preventing the progressive loss of kidney function…

Clinical Study of Neuspera*s Implantable Sacral Nerve Stimulation (SNS) System in Patients with Symptoms of Urinary Urgency Incontinence (UUI)

Primary Efficacy objective: The purpose of the study is to test the efficacy of the Neuspera Implantable SNS System for treatment of urinary urgency incontinence Primary safety objective: The primary safety objective of the study is to assess the…

Open label, long-term safety, tolerability, and efficacy study of GIVINOSTAT in all DMD patients who have been previously treated in one of the GIVINOSTAT studies.

This study has been transitioned to CTIS with ID 2023-504520-26-00 check the CTIS register for the current data. Primary objective:To assess the long term safety and tolerability of GIVINOSTAT in patients with DMD following core protocols program…

The effectiveness of adapted schema therapy for cluster C personality disorders in older adults - integrating positive schemas.

Primary ObjectiveThe aim of this study is to investigate the effectiveness of adapted ST for individuals as a treatment for cluster C PDs in older adults (aged 60 and older). More specifically, we will examine whether older patients with cluster C…

A Phase 3, Randomized, Double-blind Study to Compare the Efficacy and Safety of Pembrolizumab (MK-3475) in Combination with Lenvatinib (E7080/MK-7902) Versus Pembrolizumab and Placebo as First Line Treatment for Locally Advanced or Metastatic Urothelial Carcinoma in Cisplatin-ineligible Participants Whose Tumors Express PD-L1, and in Participants Ineligible for Any Platinum-containing Chemotherapy Regardless of PD-L1 Expression (LEAP-011)

The current study is designed to evaluate the safety and efficacy of combination therapy with pembrolizumab + lenvatinib versus pembrolizumab + placebo in cisplatin-ineligible participants whose tumors express PD-L1 (CPS >=10) and…

Efficacy and Safety of M281 in Adults with Warm Autoimmune Hemolytic Anemia: A Multicenter, Randomized, Double blind, Placebo controlled Study with a Long-term Open-label Extension

This study has been transitioned to CTIS with ID 2023-505321-14-00 check the CTIS register for the current data. Primary Objective:Efficacy of nipocalimab in participants with warm autoimmune hemolytic anemia (wAIHA)The key secondary objectives of…

A Phase I/II, Randomized, Open-label Platform Study Utilizing a Master Protocol to Study Belantamab Mafodotin (GSK2857916) as monotherapy and in Combination with Anti-Cancer Treatments in Participants with Relapsed/Refractory Multiple Myeloma (RRMM) (study 208887 DREAMM 5)

DOSE EXPLORATION:Primary:To determine the safety and tolerability of GSK2857916 in combination with other anti-cancer treatments (in each sub-study), and to establish the recommended Phase 2 dose for each sub-study combination treatment.Secondary:…

Supplemental oxygen strategies in children with bronchopulmonary dysplasia (BPD) after the neonatal intensive care unit: the SOS BPD study.

The objective of this study is to determine the optimal lower oxygen saturation target in children with moderate-severe BPD, i.e. children who are oxygen-dependent at 36 weeks PMA.

Single use vs reusable catheters in intermittent CatheterizatiOn for treatment of urinary retention: a Multicenter, Prospective, RandomizEd controlled, non-inferiority trial (COMPaRE)

The main objective of this trial is to determine whether reusable catheters are not less efficient as single use catheters, measured by symptomatic UTIs. Secondary objectives are adverse events like hospital admissions due to UTIs, urethral damage/…

Effects of closed-loop automatic control of inspiratory fraction of oxygen (FiO2-C) on outcome of extremely preterm infants-a randomized controlled parallel group multicenter trial for safety and efficacy.

To compare the effect of FiO2-C in addition to manual adjustments, in comparison with manual adjustments of FiO2 only, on death and severe complications of prematurity thought to be related to hypoxia/hyperoxia and neurodevelopmental impairment in…

A Multicenter, Randomized, Sham-controlled Study to Evaluate Safety and Efficacy After Treatment with the Nuvaira* Lung Denervation System in Subjects with Chronic Obstructive Pulmonary Disease (COPD)

Primary objective: To evaluate the efficacy of targeted lung denervation (TLD) in addition to optimal medical care to reduce moderate or severe exacerbations and related hospitalizations, compared with optimal medical care alone, in subjects with…