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Phase II study of oral metformin for intravesical treatment of non-muscle-invasive bladder cancer

The primary objective is to determine the complete response rate to administration of oral metformin Secondary objectives are: to determine the partial response rate, the overall safety of metformin, the quality of life during metformin treatment…

A Phase 1/2, First-in-Human, Open-Label, Dose Escalation Study of Talquetamab, a Humanized GPRC5D x CD3 Bispecific Antibody, in Subjects with Relapsed or Refractory Multiple Myeloma

This study has been transitioned to CTIS with ID 2023-504581-29-00 check the CTIS register for the current data. Primary* Part 1 (Dose Escalation): To characterize the safety of JNJ-64407564 and recommend thePhase 2 dose(s) and schedule* Part 2 (…

LONG-TERM FOLLOW-UP PROTOCOL FOR SUBJECTS TREATED WITH GENE-MODIFIED T CELLS

This study has been transitioned to CTIS with ID 2023-504201-36-00 check the CTIS register for the current data. Per Health Authority guidelines for gene therapy medicinal products that utilize integrating vectors (eg, lentiviral vectors), long-term…

A Phase 1/2 Study of the Oral TRK Inhibitor larotrectinib in Pediatric patients with Advanced Solid or Primary Central Nervous System Tumors

This study has been transitioned to CTIS with ID 2022-502668-20-00 check the CTIS register for the current data. PHASE 1 OBJECTIVES:Primary:To determine the safety of oral larotrectinib , including dose-limiting toxicity (DLT), in pediatric patients…

A Phase 1/2, Open-Label, Dose-Escalation Trial of GEN3013 in Patients
with Relapsed, Progressive or Refractory B-Cell Lymphoma

This study has been transitioned to CTIS with ID 2023-504802-12-00 check the CTIS register for the current data. Dose Escalation Objectives:Primary:* Determine maximum tolerated dose (MTD) and RP2DSecondary:* Establish tolerability of epcoritamab*…

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.

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)

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…

The effect of FP-025, a MMP-12 inhibitor, on allergen induced airway responses, airway inflammation and aspects of airway remodeling in subjects with mild eosinophilic House Dust Mite (HDM)-allergic asthma

To determine the effect of FP-025 vs placebo on the allergen (HDM)-induced late asthmatic response expressed as FEV1 AUC3-8h in subjects with clinically stable, mild allergic asthma and blood eosinophilia.

Study A: A placebo-controlled crossover study to assess safety of intranasal administration of palivizumab
Study B: Effect of intranasal administration of palivizumab on respiratory syncytial virus-associated infection - a double-blind randomized controlled trial

Study A: Safety of intranasal administration of palivizumab in healthy adultsStudy B: Effect of local administration of palivizumab on prevention of RSV infection

Early high-dose vitamin C in post-cardiac arrest syndrome.

Objectives:- To determine whether an early high dose i.v. vitamin C can improve organ function, especially neurological outcome, in patients after cardiac arrest- To explore the optimal dosing regimen for high dose i.v. vitamin C- To investigate in…

A randomized, double-blind, double-dummy, active-controlled, multicenter, 2-part Phase II study on replacement of steroids by IFX-1 in active granulomatosis with polyangiitis (GPA) and microscopic polyangiitis (MPA)

The primary objective is to evaluate the efficacy of IFX-1 treatment as a replacement for glucocorticoids [GC] therapy in subjects with GPA and MPA.Secondary objectives:*To assess safety and tolerability of IFX-1*To compare GC-induced toxicity of…

Individualized dosing of fludarabine during innate allo SCT: A randomized phase II study (TARGET Study)

To address whether the individualized fludarabine conditioning reduces the incidence of severe viral infections at day 100 within the context of an αβTCR / CD19 depleted transplantation regimen.

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…

A Phase 1b-2 study of Mitomycin-C / Capecitabine chemoradiotherapy combined with Ipilumimab and Nivolumab or Nivolumab monotherapy as bladder sparing curative treatment for muscle Invasive bladder Cancer: the CRIMI study.

This study has been transitioned to CTIS with ID 2023-509460-19-00 check the CTIS register for the current data. *In the phase Ib study: to assess the feasibility and safety of the addition of nivolumab and/or ipilimumab to MMC/capecitabine…

A phase 2, multicenter, randomized, double-blind, placebo controlled, dose-finding study to evaluate the efficacy and safety of IMU 838 for induction and maintenance therapy in moderate-to-severe ulcerative colitis; CALDOSE-1

To determine the optimal dose of IMU-838 to induce symptomatic remission and endoscopic healing in patients with moderate-to-severe ulcerative colitis (UC)

A Phase II, single arm, multicenter open label trial to determine the efficacy and safety of tisagenlecleucel (CTL019) in adult patients with refractory or relapsed follicular lymphoma

This study has been transitioned to CTIS with ID 2023-508127-13-00 check the CTIS register for the current data. This single arm, multi-center, phase II study will determine the efficacy and safety of tisagenlecleucel in adult patients with FL who…

An Open-label, Single Arm, Phase 2 Study to Evaluate Efficacy and Safety of Avapritinib (BLU-285), A Selective KIT Mutation-targeted Tyrosine Kinase Inhibitor, in Patients with Advanced Systemic Mastocytosis

Primary: • The primary objective is to determine adjudicated ORR (CR/CR with partial recovery of peripheral blood counts [CRh] + PR + CI) based on modified IWG-MRT-ECNM consensus response criteria in patients with AdvSM treated with avapritinib and…

The Safety and Efficacy of Psilocybin in Participants with Treatment Resistant Depression (P-TRD)

The primary objective of this study is to evaluate the efficacy of psilocybin (25 mg or 10 mg) compared to 1 mg, administered under supportive conditions to adult participants with TRD, in improving depressive symptoms, as assessed by the change in…

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…