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A Phase 3 Study Comparing Daratumumab, VELCADE (bortezomib), Lenalidomide, and Dexamethasone (D-VRd) vs VELCADE, Lenalidomide, and Dexamethasone (VRd) in Subjects with Previously Untreated Multiple Myeloma who are Eligible for High-dose Therapy

This study has been transitioned to CTIS with ID 2023-506125-10-00 check the CTIS register for the current data. The primary objective is to determine if the addition of daratumumab to VRd will prolong PFS defined as the time from the date of…

A Phase 1, Open-Label, Multicenter Study to Assess the Safety, Tolerability, Pharmacokinetics, and Preliminary Antitumor Activity of Ascending Doses of G1T48 Alone and in Combination with Palbociclib in Women with Estrogen Receptor Positive, HER2-Negative Advanced Breast Cancer

The primary objective of the study are to: 1) Determine the safety and tolerability of G1T48 alone (Parts 1 and 2) or in combination with palbociclib (Part 3), 2) Determine the MTD and RP2D of G1T48 alone (Parts 1 and 2) or in combination with…

Neoadjuvant treatment in rectal cancer with radiotherapy followed by atezolizumab and bevacizumab (TARZAN-trial)

This study has been transitioned to CTIS with ID 2024-517119-59-00 check the CTIS register for the current data. *- To explore efficacy of neoadjuvant atezolizumab and bevacizumab following radiotherapy in low- to intermediate-risk rectal cancer• To…

Tau PET imaging in cognitively normal elderly subjects: A twin approach

This study has been transitioned to CTIS with ID 2024-517634-17-01 check the CTIS register for the current data. The main objectives are to 1) investigate the relation between (longitudinal) tau and amyloid accumulation in cognitively normal…

A prospective, observational, multi-centre study investigating alterations of gut microbiome with its subsequent interaction on the brain-immune-intestine axis in patients with active relapsing remitting Multiple Sclerosis who start with oral treatment.

Primary Objective: To determine if the (change in) gut and oral microbiome at baseline or in the first 3 months after start of Cladribine is a predictor for treatment response in subjects with active relapsing remitting MS.The secondary objectives…

Basket of Baskets: A Modular, Open-label, Phase II, Multicentre Study To Evaluate Targeted Agents in Molecularly Selected Populations With Advanced Solid Tumours

This study has been transitioned to CTIS with ID 2024-514238-19-00 check the CTIS register for the current data. The general purpose of the study is to find personalized cancer treatment based on genetic analysis of tumors.

Glucocorticoid Receptor Antagonism in the Treatment of Cushing Syndrome (GRACE): A Phase 3, Double-Blind, Placebo-Controlled, Randomized-Withdrawal Study of the Efficacy and Safety of Relacorilant

Primary • To assess the efficacy of relacorilant for the treatment of endogenous Cushing syndrome based on BP control at Week 12 of the Randomized- Withdrawal (RW) phase compared with placebo• To assess the safety of relacorilant for the treatment…

A randomized, open-label, phase II open platform study evaluating the efficacy and safety of novel spartalizumab (PDR001) combinations in previously treated unresectable or metastatic melanoma

To evaluate the efficacy of each combination arm, as measured by confirmed objective response rate (ORR)

Risk, predictors, impact and outcome of anticoagulation-associated abnormal menstrual bleeding in female patients with VTE * the TEAM-VTE study

The primary objective of the TEAM-VTE study is to assess and specify the rate of new-onset abnormal menstrual bleeding in female in their fertile age, anticoagulated for an incident case of venous thromboembolism (VTE).The secondary objectives of…

A Randomized, Phase 3 Study of Eryaspase in Combination with Chemotherapy versus Chemotherapy Alone as Second-Line Treatment in Patients with Pancreatic Adenocarcinoma

Primary Objective:To determine whether the addition of eryaspase to chemotherapy improves overall survival (OS) in second-line treatment of pancreatic adenocarcinoma compared to chemotherapy alone.Secondary Objectives:• To compare progression-free…

Beyond addiction: a randomized controlled trial on the effectiveness of group schema therapy in patients with dual diagnosis

The aim of this study is to compare the effectiveness of Group Schema Therapy (G-ST) and Group Cognitive Behavioral Therapy (G-CBT+MI) on symptoms, emotion regulation and addiction in DD outpatients. Moreover the effect of the severity of childhood…

A Phase 2, Randomized, Open-Label Study of Nivolumab or Nivolumab/BMS-986205, Alone or Combined with Intravesical BCG in Participants with BCG-Unresponsive, High-Risk, Non-Muscle Invasive Bladder Cancer

Primary Objectives:- To estimate complete response rate, per pathology review committee (PRC), and its duration in CIS participantsSecondary Objectives:- To evaluate progression free survival, per pathologie review committee (PRC), for all…

Randomized controlled trial on clinical outcomes and safety of Instant MSC Product accompanying Autologous Chondron Transplantation (IMPACT) for focal articular cartilage lesions of the knee

This study has been transitioned to CTIS with ID 2024-514612-27-01 check the CTIS register for the current data. The primary objective is to measure the level of clinical improvement and quality of life at 3, 6 and 9 months compared to…

Efficacy and Safety of human apotransferrin in patients with β-thalassemia intermedia

To study the effect of apotransferrin administration in patients with β thalassemia intermedia on erythropoiesis as reflected by hemoglobin level or transfusion dependency. Secondary objectives are the effect of apotransferrin on the…

Implementation of pharmacokinetic-guided dosing of prophylaxis in hemophilia patients.

To investigate the reliability and feasibility of PK-guided prophylactic dosing of factor concentrates in hemophilia A and B patients (predictive performance).

Single-arm, multicenter, phase II study of immunotherapy in patients with type B3 thymoma and thymic carcinoma previously treated with chemotherapy - (Nivothym)

This study has been transitioned to CTIS with ID 2023-508658-24-00 check the CTIS register for the current data. Main objective: To assess PFS rate at 6 months in patients treated with nivolumab or the combination of nivolumab and ipilimumab, with…

Pharmacokinetics of cytostatic agents and tyrosine kinase inhibitors in pediatric oncology

To assess the pharmacokinetics of various cytotoxic agents (carboplatin, cisplatin, cytarabine, dactinomycin, daunorubicin, doxorubicin, etoposide, methotrexate and vincristine) and tyrosine kinase inhibitors (ALK inhibitors, MEK inhibitors, BCR-ABL…

Safe Stop Trial: observational study of the STOP & GO strategy of PD-1 blockade in advanced melanoma patients upon achieving a complete or partial response

This study has been transitioned to CTIS with ID 2024-516937-10-01 check the CTIS register for the current data. The primary objective of this study is to evaluate ongoing responses in patients with advanced and metastatic melanoma who discontinue…

Non-Alcoholic Fatty Liver Disease in children: determining the prevalence of liver fibrosis using FibroScan®

1) determine the percentage of children with probable significant fibrosis (F>=2) using FibroScan®, when screening children based on the NASPGHAN 2017 guideline.2) determine the cost-effectiveness of screening for NAFLD when following the…

Induction Study #2 - A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of Oral Ozanimod as Induction Therapy for Moderately to Severely Active Crohn's Disease

Primary objective:- Demonstrate the efficacy of ozanimod compared to placebo on the induction of clinical remissionSecondary objectives:- Demonstrate the efficacy of ozanimod compared to placebo on induction of clinical response, clinical remission…