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Randomised, Double-blind, Placebo-controlled, Multicentre Phase III Study
of Olaparib Plus Abiraterone Relative to Placebo Plus Abiraterone as First-line Therapy in
Men with Metastatic Castration-resistant Prostate Cancer.

This study has been transitioned to CTIS with ID 2024-511144-86-00 check the CTIS register for the current data. Primary objective: To determine the efficacy of the combination of olaparib and abiraterone vs placebo and abiraterone by assessment of…

A Study Evaluating the Long-term Efficacy and Safety of Ralinepag in Subjects with PAH via an Open-label Extension (ADVANCE Extension)

This study has been transitioned to CTIS with ID 2023-509305-68-00 check the CTIS register for the current data. To evaluate the long-term safety and tolerability of ralinepag (ADP811) in subjects who participated in a preceding Phase 2 or Phase 3…

Intralesional steroid injections to prevent refractory strictures in patients with esophageal atresia - a randomized controlled trial

This study has been transitioned to CTIS with ID 2023-504905-36-00 check the CTIS register for the current data. The primary objective is to find out whether ISI in children with EA can prevent refractory strictures from developing and consequently…

A phase III randomized, open-label, multi-centre, global study of Durvalumab and Bacillus Calmette-Guerin (BCG) administered as combination therapy versus BCG alone in high-risk, BCG-naive non-muscle-invasive bladder cancer patients

This study has been transitioned to CTIS with ID 2023-505341-23-00 check the CTIS register for the current data. To assess the efficacy of durvalumab + BCG (induction and maintenance) combination therapy compared to BCG (induction and maintenance)…

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…

Effectiveness of methylphenidate in children and adults with Smith Magenis syndrome and attention-deficit/hyperactivity disorder: An N-of-1 series

The primary objective is to determine the efficacy of methylphenidate on ADHD symptoms in Smith Magenis syndrome.The secondary objectives include the efficacy of methylphenidate on emotion dysregulation and specific goals that are important to the…

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…

CeRebrUm and CardIac protection with Allopurinol in neonates with critical congenital heart disease requiring cardiac surgery with cardiopulmonary bypass

This study has been transitioned to CTIS with ID 2024-513041-37-00 check the CTIS register for the current data. Primary objective of this study is to significantly reduce relevant (moderate/severe) parenchymatous brain injury on postoperative MRI…

AN OPEN-LABEL, PHASE I STUDY OF NEO-PTC-01 IN PATIENTS WITH ADVANCED OR METASTATIC MELANOMA

This study has been transitioned to CTIS with ID 2023-508524-35-00 check the CTIS register for the current data. The primary objective of this study are 1) to evaluate the safety and determine the highest tolerable dose of NEO-PTC-01 in patients…

Tiratricol treatment of children with Monocarboxylate Transporter 8 deficiency: Triac Trial II

This study has been transitioned to CTIS with ID 2024-516123-13-00 check the CTIS register for the current data. Part I:Primary Objective: Evaluate the effects of tiratricol on neurodevelopment in young MCT8 deficiency patients, as measured by the…

A Phase 1/2, Multicenter, Dose-Escalating Study To Evaluate the Safety,
Pharmacokinetics, Pharmacodynamics, and Efficacy Of Quizartinib
Administered in Combination with Re-Induction Chemotherapy, and as a
Single-Agent Continuation Therapy, in Pediatric Relapsed/Refractory AML
Subjects Aged 1 Month to <18 Years (and Young Adults Aged up to 21 Years)
with FLT3-ITD mutations

This study has been transitioned to CTIS with ID 2023-510009-16-00 check the CTIS register for the current data. Primary Objectives:• Phase 1 Only: To determine the recommended Phase 2 dose(RP2D) of quizartinib, in combination with chemotherapy,…

A Phase 3, Randomized, Study of Neoadjuvant Chemotherapy alone versus Neoadjuvant
Chemotherapy plus Nivolumab or Nivolumab and BMS-986205, Followed by Continued Post-
Surgery Therapy with Nivolumab or Nivolumab and BMS-986205 in Participants with Muscle-
Invasive Bladder Cancer

This study has been transitioned to CTIS with ID 2024-512158-12-00 check the CTIS register for the current data. Primary Objectives: - To compare the pCR rate of neoadjuvant nivolumab/BMS-986205 + GC to neoadjuvant GC alone in all randomized…

A Multicenter, Open label, Phase III Extension Trial to Study the Long-term
Safety and Efficacy in Participants with Advanced Tumors Who Are Currently on Treatment or
in Follow-up in a Pembrolizumab Trial.

This study has been transitioned to CTIS with ID 2022-501254-10-00 check the CTIS register for the current data. The purpose of this trial is to rollover participants who previously enrolled in MSD-sponsored pembrolizumab trials, including those who…

Lutetium-177-PSMA in Oligo-metastatic Hormone Sensitive Prostate Cancer.

This study has been transitioned to CTIS with ID 2023-509881-39-00 check the CTIS register for the current data. The aim of this study is to evaluate the difference in the fraction of patients that have disease progression within 6 months after…

An Open-label, Uncontrolled, Multicenter Phase II Trial of MK-3475
(Pembrolizumab) in Children and Young Adults with Newly Diagnosed Classical Hodgkin
Lymphoma with Inadequate (Slow Early) Response to Frontline Chemotherapy (KEYNOTE
667).

This study has been transitioned to CTIS with ID 2023-504821-38-00 check the CTIS register for the current data. Goal of this study is to determine the optimal balance between maintaining high rates of OS in this group and avoiding the long-term…

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…

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…