Title of the study:
"A non-interventional, multi-national, multi-center post-authorization safety study (PASS) to assess the long-term safety and tolerability of Odomzo® (sonidegib) administered in patients with locally advanced basal cell carcinoma (laBCC)"
"A non-interventional, multinational, multi-centre post-authorization safety study (PASS) to assess the long-term safety and tolerability of Odomzo® (sonidegib) administered in patients with locally advanced basal cell carcinoma (laBCC)."
Indication:
locally advanced basal cell carcinoma
Status of the study:
Recruitment closed
Phase of the study:
Phase IV
Sponsor of the study:
Sun Pharmaceutical
Study director at Ulm University Hospital:
Mrs OÄ PD Dr med. Anca Sindrilaru
Deputy:
Dr D Crisan
Dermatology study physicians:
Dr C Bechter
Title of the study:
"A Phase 1 Trial to Investigate the Safety, Pharmacokinetic Profiles and the Efficacy of Tinostamustine, a First-in-Class Alkylating Histone Deacetylase Inhibition (HDACi) Fusion Molecule, in Relapsed/Refractory Hematologic Malignancies"
"Phase I study to investigate the safety, pharmacokinetic profiles and efficacy of Tinostamustine, a first-in-class alkylating HDACi fusion molecule, in relapsed/refractory haematological malignancies."
Indication:
Recurrent/refractory cutaneous T-cell lymphoma (CTCL), subtypes mycosis fungoides (MF) and Sézary syndrome (SS)
Status of the study:
Recruitment open
Phase of the study:
Phase I study as part of the Early Clinical Trial Unit (ECTU)
Sponsor of the study:
Mundipharma
Study director at Ulm University Hospital (ECTU):
Prof Dr A. Viardot (Internal Medicine III)
Study director at the Skin Tumour Centre:
OÄ PD Dr med. Anca Sindrilaru
Title of the study:
"A Phase I/Ib, open-label, multi-centre dose-escalation and dose-expansion study of the safety and tolerability of intratumorally administered LHC165 single agent and in combination with PDR001 in patients with advanced malignancies"
"A phase I/Ib, open-label, multi-centre dose-escalation and dose-expansion study of the safety and tolerability of intratumorally administered LHC165 single agent and in combination with PDR001 in patients with advanced malignancies"
Indication:
Non-resectable / metastasised malignant melanoma with accessible macrometastases after at least one prior therapy
Status of the study:
Recruitment interrupted prematurely
Phase of the study:
Phase I study as part of the Early Clinical Trial Unit (ECTU)
Sponsor of the study:
Novartis Pharmaceuticals
Study director at Ulm University Hospital (ECTU):
Prof Dr G Schuler (ENT Clinic)
Study director at the Skin Tumour Centre:
OÄ PD Dr med. Anca Sindrilaru
Title of the study:
"A national, multicentre, open-label, non-interventional Post-Authorisation Safety Study (PASS) to assess the characteristics and management of patients with Merkel cell carcinoma in Germany
Indication:
Merkel cell carcinoma all stages
Status of the study:
Closed
Phase of the study:
Phase IV
Sponsor of the study:
Merck
Study director at Ulm University Hospital:
PD Dr A. Sindrilaru
Deputy:
Dr D Crisan
Dermatology study physicians:
Dr C Bechter
Title of the study:
"A Phase 1b/2, Open-Label Study Evaluating the Safety and Efficacy of KRT-232 in Patients with p53 Wild-Type (p53WT) Merkel Cell Carcinoma (MCC) Who Have Failed Anti-PD-1 or Anti-PD-L1 Immunotherapy, or in Combination with Avelumab in MCC Patients who are Anti-PD-1 or Anti-PD-L1 Treatment Naïve"
Indication:
Non-resectable or metastasised Merkel cell carcinoma
Status of the study:
Closed
Phase of the study:
Phase 1b/2
Sponsor of the study:
Kartos Therapeutics
Study director at Ulm University Hospital:
PD Dr A. Sindrilaru
Deputy:
Dr D Crisan
Dermatology study physicians:
Dr C Bechter
Title of the study:
Resminostat versus placebo as maintenance therapy for cutaneous T-cell lymphoma
Indication:
Patients with advanced mycosis fungoides (grade IIB-IVB) or Sezary syndrome who could be stabilised with systemic therapy
Status of the study:
Closed
Phase of the study:
Phase II
Sponsor of the study:
4SC AG
Study director at Ulm University Hospital:
PD Dr C. Pfeiffer
Dermatology study physicians:
PD Dr A. Sindrilaru
Title of the study:
ADO-CTCL-3 (TARADO): Multicentre therapy protocol for bexarotene (targretin) monotherapy in previously treated CTCL stage ≥ lb with clear assignment to an EORTC diagnosis
Indication:
Cutaneous T-cell lymphoma stage ≥ lb
Status of the study:
Recruitment closed
Phase of the study:
Phase IV
Sponsor of the study:
ADO
Study director at Ulm University Hospital:
Prof Dr K. Scharffetter-Kochanek
Deputy:
Dr K. Elsharkawi World
Dermatology study physicians:
PD Dr T. Peters
Title of the study:
A Phase 2/3, adaptive, randomized, open-label, clinical study to evaluate neoadjuvant and adjuvant V940 (mRNA-4157) in combination with pembrolizumab (MK-3475) versus standard of care and pembrolizumab monotherapy in participants with resectable locally advanced cutaneous squamous cell carcinoma (LA cSCC)
Indication:
Squamous cell carcinoma of the skin, resectable, locally advanced, stage II-IV (M0)
Status of the study:
Ongoing contract negotiations
Phase of the study:
Phase 2 / 3
Sponsor of the study:
Merck Sharp & Dohme LCC
Study director at Ulm University Hospital:
PD Dr med. Anca Sindrilaru
Deputy:
Dr med Diana Crisan
Dermatology study physicians:
Clemens Bechter, Alexandra Maselbas