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A phase II study of Vorinostat in patients with Polycythaemia Vera and Essential Thrombocythaemia

1. To evaluate efficacy of vorinostat in the treatment of patients with polycythaemia vera (PV) and essential thrombocythaemia (ET) 2. To evaluate if vorinostat as monotherapy of patients with PV and ET is followed by a decline in clonal…

A phase II study of sorafenib and metformin in patients with locally advanced and/or metastatic non-smal cell lung cancer (NSCLC) with a K-Ras mutation

To assess the efficacy of combined treatment with sorafenib and metformin.

Sentinel lymph node identification in colon and rectal cancer using a radioactive and fluorescent tracer

Aim of the present study is to investigate if a combination of a radioactive and fluorescent tracer can increase the sensitivity and specificity of the SLNM technique in colon and rectal cancer by utilizing the radioactive component for preoperative…

Long term, multicenter, single-arm, open-label extension study of the MERIT-1 study, to assess the safety, tolerability and efficacy of macitentan in subjects with inoperable chronic thromboembolic pulmonary hypertension (CTEPH)

Safety objective:• To evaluate the long-term safety and tolerability of macitentan 10 mg in subjects withinoperable CTEPH.Efficacy objectives:• To evaluate the long term effects of macitentan 10 mg on exercise capacity andfunctional class (FC).

Phase 1b/2 Study Combining Hepatic Percutaneous Perfusion with Ipilimumab plus Nivolumab in advanced Uveal Melanoma

This study has been transitioned to CTIS with ID 2024-516125-31-02 check the CTIS register for the current data. Primary objective is to determine safety and tolerability, dose limiting toxicities (DLTs), maximum tolerated dose (MTD) and recommended…

Phase 2 INSPIRE trial: Ipilimumab with Nivolumab in molecular-Selected patients with castration-resistant PRostate cancer

This study has been transitioned to CTIS with ID 2024-513186-39-00 check the CTIS register for the current data. Primary objective:To evaluate the efficacy of nivolumab in combination with ipilimumab in molecular pre-selected patients with…

[18F]PEG-Folate PET-CT imaging for monitoring of therapy response in Rheumatoid Arthritis patients

This study has been transitioned to CTIS with ID 2024-513537-21-00 check the CTIS register for the current data. To investigate the association between quantitative changes in whole body F-18-PEG Folate PET/CT (Folate PET) after 4 weeks and clinical…

An Open- Label, Phase 2, Multicenter Feasibility Study if Manualized MDMA-Assisted Psychotherapy with an fMRI sub-study Assessing Changes in Brain Activity in Subjects with Post-Traumatic Stress Disorder

The overall objective of this study is to use standard clinical measures to explore the safety and effects of open-label manualized MDMA-assisted psychotherapy with a flexible dose of MDMA in participants with severe PTSD, and to serve as an…

COntinue the SaMe systemic therapy after local ablative therapy for Oligo progression in metastatic breast cancer - the COSMO study

The aim of this study is to find out how long the disease remains stable if we treat the 1-2 growing metastasis(s) locally by removing or irradiating/heating them, while continuing the treatment with your current drugs (anti-hormonal therapy,…

Safety and feasibility of CT-guided percutaneous radionuclide therapy with the OncoSil* device in patients with non-progressive locally advanced pancreatic cancer (PANCOSIL): an open-label, single-arm phase 1-2 feasibility study

To assess the safety and feasibility of percutaneous CT-or ultrasound-guided RNT using the Oncosil* device in patients with non-progressive LAPC after induction chemotherapy treatment.

Primary percutaneous placement of metal stents for palliative biliary drainage in patients with a primary malignant perihilar stricture

To proof feasibility and safety of direct SEMS placement for palliative treatment of perihilar cholangiocarcinoma.

A phase 2, single arm, European multi-center trial evaluating the efficacy of afatinib as first-line or later-line treatment in advanced chordoma.

Primary objectives- To evaluate the treatment efficacy by progression free survival (PFS) according to RECIST 1.1. - Quality of life assessmentSecondary objectives- To evaluate the treatment efficacy by growth modulation index- To evaluate the…

CHIP-AML22/Quizartinib: A phase II, single arm, open label, study on the safety, efficacy, pharmacokinetics and pharmacodynamics of quizartinib in combination with chemotherapy and as single-agent after high dose therapy in newly diagnosed pediatric FLT3-ITD positive and NPM1 wild type AML patients.
(A linked-trial of the CHIP-AML22/Master protocol by the NOPHO-DB-SHIP consortium)

This study has been transitioned to CTIS with ID 2023-505000-27-01 check the CTIS register for the current data. To investigate the safety and efficacy of quizartinib in children and adolescents with newly diagnosed FLT3-ITD positive AML with normal…

A Phase 2, Open-Label, Single-Arm, Multicenter Study to Evaluate the Efficacy and Safety of Pemigatinib in Participants With Previously Treated Glioblastoma or Other Primary Central Nervous System Tumors Harboring Activating FGFR1-3 Alterations (FIGHT-209)

Main objective: To determine the efficacy of pemigatinib in participants with recurrent GBM with an activating FGFR1-3 mutation or fusion/rearrangement. Secondary objectives: 1. To determine the efficacy of pemigatinib in participants with recurrent…

A Phase 2, Multicenter Study to Evaluate the Efficacy and Safety Using Autologous Tumor Infiltrating Lymphocytes (LN-145) in Patients with Recurrent, Metastatic, or Persistent Cervical Carcinoma

This study has been transitioned to CTIS with ID 2024-510634-41-00 check the CTIS register for the current data. Cohort 1 - LN-145 monotherapy in patients who have progressed during or following systemic therapy for recurrent, metastatic, or…

SGM-101 tumor-targeted fluorescence endoscopy to enable discrimination of malignant from benign tissue in rectal polyps with suspected T1 adenocarcinoma or high grade dysplasia: a feasibility study

This study has been transitioned to CTIS with ID 2024-510769-41-00 check the CTIS register for the current data. The main objective is to investigate the feasibility of a tumour-targeted fluorescent tracer SGM-101, combined with the use of the CE-…

Phase 2 study of daratumumab monotherapy in previously untreated patients with stage 3B light chain (AL) amyloidosis

The primary hypothesis of this study is that the 6-month OS rate of patients with newly diagnosed stage 3B AL amyloidosis will exceed 50% after primary therapy with daratumumab

A phase II open-label study with the anti-PD-L1 Atezolizumab monoclonal antibody in combination with Bevacizumab in patients with advanced chemotherapy resistant colorectal cancer and MSI-like molecular signature

The primary objective of this study is to determine the anti-tumor activity, as measured by overall response rate (ORR) of atezolizumab in combination with bevacizumab in patients with chemotherapy resistant CRC and positivity for MSI-like molecular…

Pilot study of FAPI PET/CT for locoregional (re)staging of lymph nodes in colorectal carcinoma

To describe the accuracy of FAPI PET/CT in the detection of regional lymph node metastases in patients with colorectal cancer in comparison with standard diagnostic imaging and (in operated patients) histopathology, aiming to provide early evidence…

A phase II trial in patients with myelofibrosis (primary, post-ET or post PV-MF) treated with the selective JAK2 inhibitor Pacritinib before reduced-intensity conditioning allogeneic stem cell transplantation

Improve allo-SCT transplant outcome using a uniform conditioning regimen and pacritinib pretreatment by means of the proportion of patients with a failure within 6 months post-transplant. Events that are considered a failure are: primary graft…