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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 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…

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, Randomized, Open-Label, Multi-Center, Global Study to Determine the Efficacy and Safety of Durvalumab in Combination with Gemcitabine+Cisplatin for Neoadjuvant Treatment Followed by Durvalumab Alone for Adjuvant Treatment in Patients with Muscle-Invasive Bladder Cancer

This study has been transitioned to CTIS with ID 2023-510015-19-00 check the CTIS register for the current data. The treatment options currently available for MIBC- patients remain limited, current standard therapy is likely to result in modest…

A Phase 3, Open -label, Randomized Study to Compare the Efficacy and Safety of Luspatercept (ACE-536) versus Epoetin alfa for the Treatment of Anemia due to IPSS-R Very Low, Low or Intermediate Risk Myelodysplastic Syndromes (MDS) in ESA Naïve Subjects who require Red Blood Cell Transfusions.

This study has been transitioned to CTIS with ID 2022-501485-22-00 check the CTIS register for the current data. Primary objective:• To evaluate the efficacy of luspatercept on RBC transfusion independence (RBC-TI for 12 weeks [84 days] with an…

SUSTRENIM - GIMEMA CML1415 / HOVON 142 CML

This study has been transitioned to CTIS with ID 2023-510434-83-00 check the CTIS register for the current data. The study will investigate in newly diagnosed CP-CML patients the efficacy of NIL frontline therapy vs IM followed by switch to NIL in…

Tisagenlecleucel versus standard of care in adult patients with relapsed or refractory aggressive B-cell non-Hodgkin lymphoma: A randomized, open label, phase III trial

This study has been transitioned to CTIS with ID 2023-508343-48-00 check the CTIS register for the current data. To compare tisagenlecleucel treatment strategy to SOC treatment strategy with respect to delaying the composite event of disease…

A Randomized, Open-label, Phase 3 study of the Combination of Ibrutinib plus Venetoclax versus Chlorambucil plus Obinutuzumab for the First-line Treatment of Subjects with Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL)

This study has been transitioned to CTIS with ID 2023-503469-49-00 check the CTIS register for the current data. Primary ObjectiveThe primary objective of the study is to assess progression-free survival (PFS) from treatment with ibrutinib plus…

A phase 3, multicenter, open-label, randomized, study of gilteritinib versus midostaurin in combination with induction and consolidation therapy followed by one-year maintenance in patients with newly diagnosed Acute Myeloid Leukemia (AML) or Myelodysplastic syndromes with excess blasts-2 (MDS-EB2) with FLT3 mutations eligible for intensive chemotherapy

This study has been transitioned to CTIS with ID 2022-502478-18-00 check the CTIS register for the current data. To compare OS between gilteritinib and midostaurin in combination with induction therapy and consolidation therapy followed by one-year…

The ENDURRANCE-1 Study. ;Exploring durable remission with rituximab in ANCA associated vasculitis

This study has been transitioned to CTIS with ID 2023-507868-39-00 check the CTIS register for the current data. In this randomized study the primary objective is to demonstrate a clinical significant reduction of RTX retreatments in AAV patients…

A phase II trial of tisagenlecleucel in first-line high-risk (HR) pediatric and young adult patients with B-cell acute lymphoblastic leukemia (B-ALL) who are minimal residual disease (MRD) positive at the end of consolidation (EOC) therapy (CCTL019G2201J)

This study has been transitioned to CTIS with ID 2023-508081-15-00 check the CTIS register for the current data. Primary: - To evaluate the efficacy of tisagenlecleucel therapy as measured by the overall survival (OS)- To evaluate the efficacy of…

A Stratification trial to determine key immunological factors predicting Tofacitinib efficacy in Psoriatic Arthritis (PsA). TOFA-PREDICT

This study has been transitioned to CTIS with ID 2024-510903-12-00 check the CTIS register for the current data. Primary objective:Identify pre-treatment profiles with integrated clinical, transcriptomic, metabolomic, proteomic, flow cytometric, and…

A Phase 3, Randomized, Comparator-controlled Clinical Trial to Study the Efficacy and Safety of Pembrolizumab (MK-3475) in Combination with Bacillus Calmette-Guerin (BCG) in Participants with High-risk Non-muscle Invasive Bladder Cancer (HR NMIBC) that is Persistent or Recurrent Following BCG Induction (KEYNOTE-676)

This study has been transitioned to CTIS with ID 2022-501817-29-00 check the CTIS register for the current data. Cohort ATo compare the CRR for the combination of pembrolizumab + BCG versus BCG alone in participants with CIS.Cohort B- To compare the…

Combination of targeted therapy (encorafenib and binimetinib) followed by combination of immunotherapy (ipilimumab and nivolumab) vs immediate combination of immunotherapy in patients with unresectable or metastatic melanoma with BRAF V600 mutation : an EORTC randomized phase II study (EBIN)

This study has been transitioned to CTIS with ID 2023-505376-30-00 check the CTIS register for the current data. The primary objective is to prospectively assess whether a sequential approach with an induction period of 12 weeks with encorafenib +…