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A Phase III, Open-Label, Randomized Study to Evaluate the Efficacy and Safety of Single Agent Belantamab Mafodotin Compared to Pomalidomide plus Low-dose Dexamethasone (pom/dex) in Participants with Relapsed/Refractory Multiple Myeloma (RRMM) (DREAMM 3)

This study has been transitioned to CTIS with ID 2023-508962-14-00 check the CTIS register for the current data. Primary objective:To compare the efficacy with belantamab mafodotin vs pomalidomide plus low dose dexamethasone (pom/dex) in…

DREAMM 7: A Multicenter, Open-Label, Randomized Phase III Study to Evaluate the Efficacy and Safety of the Combination of Belantamab Mafodotin, Bortezomib, and Dexamethasone (B-Vd) Compared with the Combination of Daratumumab, Bortezomib and Dexamethasone (D-Vd) in Participants with Relapsed/Refractory Multiple Myeloma (study 207503, DREAMM 7)

This study has been transitioned to CTIS with ID 2023-510537-28-00 check the CTIS register for the current data. Primary:To compare the efficacy of BM in combination with BOR/DEX with that of daratumumab in combination with BOR/DEX in participants…

A Phase 3, Randomized, Parallel-Group, Multicenter, Open-Label Pharmacokinetic, Noninferiority Study of Ravulizumab Administered Subcutaneously Versus Intravenously in Adult Patients With Paroxysmal Nocturnal Hemoglobinuria Currently Treated With Eculizumab

Primary:• To evaluate PK noninferiority of ravulizumab SC versus ravulizumab IV in adult patients with PNH Secondary• To characterize PK of ravulizumab SC• To characterize PD of ravulizumab SC• To characterize immunogenicity of ravulizumab SC• To…

PSMA-PET guided hypofractionated salvage prostate bed radiotherapy of biochemical failure after radical prostatectomy for prostate cancer

The main goal of this project is to investigate whether the oncologic outcome in patients with post-prostatectomy recurrent PCa can be improved, by increasing the biological effective radiation dose using a hypofractionated schedule of 20 x 3 = 60…

A randomized phase III study of neoadjuvant chemotherapy followed by surgery versus surgery alone for patients with High Risk RetroPeritoneal Sarcoma

This study has been transitioned to CTIS with ID 2023-505261-84-00 check the CTIS register for the current data. The primary objective of this study is to assess whether preoperative chemotherapy, as an adjunct to curative-intent surgery, improves…

A Phase 2/3, Randomized, Double-blind, Placebo- and Active-controlled, Parallel-group, Multicenter Protocol to Evaluate the Efficacy and Safety of Guselkumab in Participants with Moderately to Severely Active Crohn's Disease

This study has been transitioned to CTIS with ID 2023-504736-18-00 check the CTIS register for the current data. Primary Objectives (Phase 2 and Phase 3):- To evaluate the clinical efficacy of guselkumab in participants with Crohn*s disease- To…

The Effect of Tirzepatide versus Dulaglutide on Major Adverse Cardiovascular Events in Patients with Type 2 Diabetes (SURPASS-CVOT)

This study has been transitioned to CTIS with ID 2023-507846-96-00 check the CTIS register for the current data. The main reason for conducting this study is to help in answering the following research question:• How tirzepatide compares to…

Randomized, Embedded, Multifactorial, Adaptive Platform trial for Community-Acquired Pneumonia (REMAP-CAP)

This study has been transitioned to CTIS with ID 2023-507889-89-00 check the CTIS register for the current data. REMAP-CAP: The goal of the study is to investigate the best treatment regime for pneumonia patients. For non-pandemic pneumonia (…

A Phase 3 Study Comparing Daratumumab, VELCADE (bortezomib), Lenalidomide, and Dexamethasone (D-VRd) with VELCADE, Lenalidomide, and Dexamethasone (VRd) in Subjects with Untreated Multiple Myeloma and for Whom Hematopoietic Stem Cell Transplant is Not Planned as Initial Therapy

This study has been transitioned to CTIS with ID 2023-507312-13-00 check the CTIS register for the current data. Primary ObjectiveThe primary objective is to determine if the addition of daratumumab to VELCADE (bortezomib),Revlimid (lenalidomide),…

A Phase III, multicenter, randomized, double-blind study to assess efficacy and safety of two doses of crizanlizumab versus placebo, with or without hydroxyureal/hydroxycarbamide therapy, in adolescent and adult sickle cell disease patients with vaso-occlusive crises (STAND)

This study has been transitioned to CTIS with ID 2023-508689-14-00 check the CTIS register for the current data. To compare the efficacy of 7.5 mg/kg of crizanlizumab versus placebo on the annualized rate of VOC leading to healthcare visit, in…

A PHASE III, RANDOMIZED, OPEN-LABEL, ACTIVE-CONTROLLED, MULTICENTER STUDY EVALUATING EFFICACY AND SAFETY OF CROVALIMAB VERSUS ECULIZUMAB IN PATIENTS WITH PAROXYSMAL NOCTURNAL HEMOGLOBINURIA (PNH) NOT PREVIOUSLY TREATED WITH COMPLEMENT INHIBITORS

This study has been transitioned to CTIS with ID 2023-506498-36-00 check the CTIS register for the current data. To evaluate the efficacy of crovalimab compared to eculizumab

Adjuvant encorafenib & binimetinib vs. placebo in fully resected stage IIB/C BRAF V600E/K mutated melanoma: a randomized triple-blind phase III study in collaboration with the EORTC Melanoma Group

To characterize the safety and tolerability.1. To describe the available RFS data by treatment arm.2. To describe the available DMFS data by treatment arm.3. To describe-reported health-related quality of life (HRQoL) bytreatment arm.

A phase 3 multicentre, randomized, prospective, open-label trial of Ibrutinib monotherapy versus fixed-duration Venetoclax plus Obinutuzumab versus fixed-duration Venetoclax plus Ibrutinib in patients
with previously untreated chronic lymphocytic leukaemia (CLL).

This study has been transitioned to CTIS with ID 2022-500439-35-00 check the CTIS register for the current data. The primary objective of the study is to compare the efficacy of continuous ibrutinib monotherapy with fixed-duration venetoclax plus…

In Balans: the (cost-)effectiveness of the In Balans fall prevention training on falls and fall injuries in community-dwelling older adults with an increased risk of falls

The aim of this study is to investigate the (cost-)effectiveness of the 'In Balans' fall prevention program. We will research the effect of 'In Balans' on the number of falls, fall injuries, physical performance (including…

Upfront autologous hematopoietic stem cell transplantation versus immunosuppressive medication in early diffuse cutaneous systemic sclerosis: an international multicentre, open-label, randomized controlled trial

This study has been transitioned to CTIS with ID 2023-505877-34-00 check the CTIS register for the current data. To determine the optimal treatment strategy in early dcSSc: the effect of HSCT as upfront therapy compared with that of…

A Randomized Controlled Trial of AttraX® Putty vs. conventional open-wedge osteotomy without gap filler in open-wedge osteotomy

The main aim of this study is to determine whether early postoperative pain is decreased when the osteotomy gap is filled with AttraX® Putty, compared to conventional open wedge osteotomy without filling the gap. The secondary aims are faster…

A phase Ib/II randomized double-blind placebo controlled trial evaluating the effect of Nivolumab for patients with in-transit melanoma metastases treated with isolated limb perfusion (NivoILP trial)

This study has been transitioned to CTIS with ID 2023-509265-21-00 check the CTIS register for the current data. To evaluate safety and the effect of isolated limb perfusion together with nivolumab as a way to increase efficacy and give further…

Phase 3 Randomized, Controlled Study of Blinatumomab Alternating With Low-intensity Chemotherapy Versus Standard of Care for Older Adults With Newly Diagnosed Philadelphia-negative B-cell Precursor Acute Lymphoblastic Leukemia With Safety Run-in (Golden Gate Study)

This study has been transitioned to CTIS with ID 2023-503640-14-00 check the CTIS register for the current data. Primary:• To compare event-free survival (EFS) of subjects receiving blinatumomab alternating with low-intensity chemotherapy to EFS of…

Phase III study comparing R-CODOX-M/R-IVAC versus dose-adjusted EPOCH-R (DA-EPOCH-R) for patients with newly diagnosed high risk Burkitt lymphoma

Primary objective:- To confirm in a multicenter setting an improvement in EFS to 95% at 2 years of DA-EPOCH-R in patients with newly diagnosed high risk Burkitt lymphoma as compared to an expected EFS of 72% at 2 years for the control arm R-CODOX-M/…

A Phase 3, Randomized, Double-Blind Study of Adjuvant Immunotherapy with Nivolumab versus Placebo after Complete Resection of Stage IIB/C Melanoma (CA209-76K)

This study has been transitioned to CTIS with ID 2022-502354-14-00 check the CTIS register for the current data. Primary Objective:To measure the efficacy provided by nivolumab therapy on its own compared to placebo in participants who have had…