Clinical studies in neuro-oncological diseases
The Department of Neurology and Polyclinic, in cooperation with the Department of Neurosurgery, the Departments of Neuroradiology, Neuropathology and Radiotherapy and the National Centre for Tumour Diseases, offers participation in multicentre, national and international therapy studies for a range of brain tumours. These therapy studies aim to improve brain tumour therapy and are coordinated by our department, the German Cancer Society's neuro-oncological working group (NOA), the European Organisation for Research and Treatment of Cancer (EORTC), pharmaceutical companies and/or other national study centres. You are welcome to contact us for details of the respective therapy studies.
The following clinical trials are currently available:
| Focus on | Neurooncology |
| Indication | Tumours with BRAF alterations |
| Short title | F8394-201 |
| Study title | Evaluation of the efficacy and safety of FORE8394, a BRAF inhibitor |
| Short description | The aim of this study is to evaluate the efficacy, safety, pharmacokinetics and pharmacodynamics of FORE8394 in defined subgroups of participants with tumours with BRAF alterations. |
| Phase | PHASE II |
| EudraCT-Number | 2022-000627-20 |
| Study status | Study in recruitment |
| Contact: Antje Wick | Antje Wick Antje.Wick@med.uni-heidelberg.de |
| Focus on | Neurooncology |
| Indication | Newly diagnosed glioblastomas |
| Short title | GBM AGILE |
| Study title | Global Adaptive Trial Master Protocol for the evaluation of multiple therapies in newly diagnosed and recurrent GBM |
| Short description | GBM AGILE is an international phase II/III trial with adaptive randomisation platform to evaluate multiple therapies in newly diagnosed and recurrent glioblastoma with the aim of identifying effective therapies. |
| Phase | II/III |
| EudraCT-Number | 2020-002250-24 |
| Study status | Study in recruitment |
| Contact: Antje Wick | Antje Wick Antje.Wick@med.uni-heidelberg.de |
| Focus on | Neurooncology |
| Indication | Newly diagnosed H3 diffuse gliomas with K27M mutation |
| Short title | ONC201-108-ACTION |
| Study title | ONC201 for the treatment of newly diagnosed H3 K27M-mutated diffuse gliomas after completion of radiotherapy. |
| Brief description | Randomised, double-blind, placebo-controlled, international phase 3 study in patients with newly diagnosed diffuse glioma with H3 K27M mutation to test whether treatment with ONC201 radiotherapy prolongs overall survival. |
| Phase | III |
| EudraCT-Number | 2022-502051-56-00 |
| Status | Study in recruitment |
| Contact: Antje Wick | Antje Wick Antje.Wick@med.uni-heidelberg.de |
| Focus on | Neurooncology |
| Indication | Newly diagnosed "MGMT-unmethylated" glioblastomas |
| Short title | CV-GBLM-001 |
| Study title | Dose-finding study to evaluate the safety and tolerability of CVGBM in patients with surgically resected glioblastoma, or astrocytoma with a molecular signature of an unmethylated glioblastoma. |
| Brief description | This study is an open-label, first-in-human, dose-escalation study of the CV09050101 mRNA vaccine (CVGBM) in patients with newly diagnosed "MGMT-unmethylated" glioblastoma. |
| Phase | I |
| EudraCT-Number | EudeaCT 2022-501423-25-00 |
| Study status | Study in recruitment |
| Contact: Antje Wick | Antje Wick Antje.Wick@med.uni-heidelberg.de |
| Focus on | Neurooncology |
| Indication | Primary CNS lymphoma |
| Short title | NOA-13 |
| Study title | Prospective observational study on chemotherapy in non-specifically pre-treated patients with primary CNS lymphoma (PZNSL). |
| Brief description | The NOA-13 study is a prospective registry to record the current treatment practice in the first-line therapy of patients with primary CNS lymphoma. All patients with non-specifically pre-treated primary CNS lymphoma for whom guideline-compliant, i.e. methotrexate-based high-dose chemotherapy without whole-brain radiotherapy is planned are included. |
| Phase | Prospective observational study |
| Status | Study in recruitment |
| Contact: Antje Wick | Antje Wick Antje.Wick@med.uni-heidelberg.de |
| Focus on | Neurooncology |
| Indication | NTRK fusion-positive advanced or metastatic solid tumours |
| Short title | PBI-200-101 |
| Study title | PBI-200 in patients with NTRK fusion-positive advanced or metastatic solid tumours |
| Short description | The aim of this study is to evaluate the efficacy, safety, pharmacokinesThis is the first open-label, multicentre study of PBI-200 in patients with NTRK fusion-positive advanced or metastatic solid tumours. Phase 1 will also be conducted in patients with NTRK-amplified advanced or metastatic solid tumours, or refractory EWSR1-WT1-positive desmoplastic round cell tumours (DSRCTs). |
| Phase | I/II |
| EudraCT-Number | 2021-001029-32 |
| Status | Study in recruitment |
| Contact: Antje Wick | Antje Wick Antje.Wick@med.uni-heidelberg.de |
| Focus on | Neurooncology |
| Indication | Molecularly favourable diffuse brain tumours (WHO grade II and III gliomas with 1p and 19q codeletion) |
| Short title | IMPROVE CO-DEL |
| Study title | Improving functional outcome for patients with newly diagnosed grade II or III glioma with co-deletion of 1p/19q (IMPROVE CO-DEL): a NOA study. |
| Brief description | The study project plans to treat patients with molecularly favourable diffuse brain tumours (WHO grade II and III gliomas with 1p and 19q codeletion). The standard therapy for these patients has recently been combined radio-chemotherapy. This radio-chemotherapy includes partial brain irradiation and drug treatment with procarbazine, lomustine and vincristine. |
| Phase | III |
| EudraCT-Number | 2018-005027-16 |
| Status | Study in recruitment |
| contact | Wolfgang Wick Wolfgang.Wick@med.uni-heidelberg.de |
| Focus on | Neurooncology |
| Indication | Glioblastoma EORTC 2227 |
| Short title | Legato |
| Study title | Lomustine with or without reirradiation for first progression of glioblastoma: a randomised phase III trial (LEGATO) |
| Brief description | The primary objective of this phase III trial is to show that overall survival (OS) is superior with lomustine plus radiotherapy compared to lomustine monotherapy in first progression of glioblastoma. |
| Phase | III |
| EudraCT-Number | 2023-505267-36-00 |
| Status | Study in recruitment as of June 2024 |
| Contact: Antje Wick | Antje Wick Antje.Wick@med.uni-heidelberg.de |
| Focus on | Neurooncology |
| Indication | Progressive MGMT-methylated glioblastomas |
| Short title | MecMeth |
| Study title | Meclofenamate in progressive MGMT-methylated glioblastoma under second-line temozolomide therapy |
| Short description | The primary objective of Phase I is to determine the toxicity of meclofenamate sodium therapy in addition to standard temozolomide and to determine the recommended daily dose of meclofenamate sodium on this basis. In Phase II, the primary objective is to achieve the efficacy of meclofenamate sodium therapy in addition to standard therapy. |
| Phase | I/II |
| EudraCT-Number | 2021-000708-39 |
| Study status | Study in recruitment |
| contact | Frank Winkler Frank.Winkler@med.uni-heidelberg.de |
| Focus on | Neurooncology |
| Indication | Progressive glioblastomas |
| Short title | PerSurge / NOA-30 |
| Study title | Clinical and translational controlled study on perioperative perampanel treatment of patients with progressive glioblastoma |
| Brief description | The PerSurge study is a multicentre study investigating the effects of perampanel treatment on tumour growth and tumour cell characteristics before and after planned surgery for regrowing glioblastoma. Perampanel can inhibit the malignant synapses with nerve cells that contribute to the growth and resistance of glioblastoma. |
| Phase | PHASE II |
| status | Study in recruitment |
| Contact | Frank Winkler Frank.Winkler@med.uni-heidelberg.de |