NCT/UCC Clinical Trial Center

The Clinical Trial Center (CTC) is the central platform for the coordination and management of investigator initiated trials (IIT) at the National Center for Tumor Diseases Dresden of the University Cancer Center (NCT/UCC). The CTC provides assistance from the early planning phase to the actual conduct of clinical trials, from phase 1 to 3 in the field of hematology and oncology.

In order to assure adherence to the high standards according to GCP regulations for clinical trials (under European and German law) and successful completion of trial projects, the CTC collaborates with the following organisations:

• University Hospital Carl Gustav Carus Dresden
• Dresden University of Technology
• BioBank Dresden (BBD)
• German Cancer Research Center (dkfz)
• Helmholtz Center Dresden Rossendorf (hzdr)
• Clinical trial center of the NCT Heidelberg

Provided services for Investigator Initiated Trials

• Planning, implementation and archiving, feasibility in advance
• Coordination of submissions to and communication with regulatory authorities and institutional review boards
• Contract management
• Coordination and implementation of sponsor oversight, monitoring, database setup and management
• GCP-compliant treatment of patients and data-acquisition

Methods used (excerpt)

• Consulting by experienced senior investigators
• Study Coordination performed by experienced project managers and study coordinators
• Patient treatment by specifically trained study nurses
• Documentation by experienced data managers and state of the art electronic data systems
• Implementation of specified data bank management tools for clinical trials

Examples of clinical trials we currently support

• ALPINE - A Phase II, single-arm trial of Atezolizumab/Platinum/Etoposide for the treatment of advanced large-cell neuroendocrine cancer of the lung
• CARLOTTA01 - A Phase I trial to establish the safety and maximum tolerated dose of high-affinity autologous BCMA-targeting CAR-T cells in patients with relapsed and refractory B-cell malignancies
• ImmunoSABR - Phase II study examining the activity of L19-IL2 immunotherapy and stereotactic ablative radiotherapy in metastatic non-small cell lung cancer
• PMO-1604 - Afatinib in Advanced NRG1-Rearranged Malignancies: the NCT/DKTK PMO-1604 Phase-II Trial
• SORATRAM - Cross-institutional, prospective, open label, single group basket study of combined CRAF and MEK inhibition in advanced-stage malignancies harboring BRAF mutations with impaired kinase activity

Platform Directors

Prof. Dr. med. Martin Wermke
Trial Site Management at CTC
Senior physician, Director of Early Clinical Trial Unit
Medizinische Klinik und Poliklinik I
Universitätsklinikum TU Dresden

Prof. Dr. med. Christoph Röllig, MSc
Trial Conduct and Sponsor Affairs at CTC
Senior physician, Division Manager Clinical Trials
Medizinische Klinik und Poliklinik I
Universitätsklinikum TU Dresden