Title of the study:
"A Multicenter, Randomised, Double-Blind Phase 3 Study of HBI-8000 Combined with Nivolumab versus Placebo with Nivolumab in Patients with Unresectable or Metastatic Melanoma Not Previously Treated with PD-1 or PD-L1 Inhibitors"
"Multicentre, randomised, double-blind, phase 3 study comparing HBI-8000 in combination with nivolumab versus placebo in combination with nivolumab in patients with unresectable or metastatic malignant melanoma not previously treated with PD-1 or PD-L1 inhibitors"
Indication:
Locally advanced, unresectable or metastasised malignant melanoma
Status of the study:
Recruitment closed
Phase of the study:
Phase III
Sponsor of the study:
HUYA Bioscience International
Study director at Ulm University Hospital:
Mrs PD Dr med. Anca Sindrilaru
Deputy:
Dr D Crisan
Dermatology study physicians:
Clemens Bechter, Alexandra Maselbas
Title of the study:
A randomised, open-label, phase III study of the fixed-dose combination of subcutaneous nivolumab + relatlimab versus the fixed-dose combination of intravenous nivolumab + relatlimab in participants with previously untreated metastatic or unresectable melanoma.
Indication:
malignant melanoma,untreated, metastasised or unresectable
Status of the study:
Recruitment closed
Phase of the study:
Phase 3
Sponsor of the study:
Bristol-Myers Squibb Company (BMS)
Study director at Ulm University Hospital:
PD Dr med. Anca Sindrilaru
Deputy:
Dr med Diana Crisan
Dermatology study physicians:
Clemens Bechter, Alexandra Maselbas
Title of the study:
"Encorafenib plus binimetinib in patients with locally advanced, unresectable or metastatic BRAFV600-mutated melanoma: a multi-centric, multi-national, prospective, longitudinal, non-interventional study in Germany and Austria - BERINGMELANOMA"
"Encorafenib Plus Binimetinib in patients with locally advanced, unresectable or metastatic BRAFV600-mutated melanoma: a multi-centric, multi-national, prospective, longitudinal, non-interventional study in Germany, Austria and Switzerland"
Indication:
Locally advanced, unresectable or metastasised BRAFV600-mutated malignant melanoma
Status of the study:
Recruitment open
Phase of the study:
Phase IV
Sponsor of the study:
Pierre Fabre Pharma
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 national, prospective, non-interventional study (NIS) of nivolumab (BMS-936558) monotherapy or in combination with ipilimumab in patients with advanced (unresectable or metastatic) melanoma (study number: CA 209654)
Indication:
Advanced stage III (inoperable) or stage IV melanoma of the skin, uvea or mucous membrane
Status of the study:
Recruitment closed
Phase of the study:
Phase IV
Sponsor of the study:
Bristol-Myers Squibb (BMS)
Study director at Ulm University Hospital:
Prof. M. Huber (until 30.9.2018) PD Dr A. Sindrilaru (from 1.10.2018)
Dermatology study physicians:
Dr D. Crisan,
Title of the study:
Multicentre, randomised, double-blind, placebo-controlled, phase III trial comparing the combination of PDR001, dabrafenib and trametinib versus placebo, dabrafenib and trametinib in previously untreated patients with unresectable or metastatic BRAF V600-mutated melanoma (EudraCT No. 2016-002794-35)
Indication:
Metastasised BRAFV600 wild-type melanoma, not systemically pretreated, treated stable brain metastases permitted
Status of the study:
Closed
Phase of the study:
Phase III
Sponsor of the study:
F. Hoffman-La Roche Ltd.
Study director at Ulm University Hospital:
PD Dr A. Sindrilaru
Dermatology study physicians:
Dr D. Crisan,
Title of the study:
Multicentre, randomised, double-blind, placebo-controlled, phase III trial comparing the combination of PDR001, dabrafenib and trametinib versus placebo, dabrafenib and trametinib in previously untreated patients with unresectable or metastatic BRAF V600-mutated melanoma (EudraCT No. 2016-002794-35)
Indication:
Advanced melanoma stage III (inoperable) or stage IV of the skin with BRAF V600 mutation, not systemically pretreated, treated stable brain metastases permitted
Status of the study:
Closed
Phase of the study:
Phase III
Sponsor of the study:
Novartis
Study director at Ulm University Hospital:
Prof. M. Huber (until 30.9.2018) PD Dr A. Sindrilaru (from 1.10.2018)
Dermatology study physicians:
Dr D. Crisan,
Title of the study:
A non-interventional study to investigate the efficacy, safety and benefit of cobimetinib and vemurafenib in patients with and without brain metastases with BRAFV600 mutated melanoma under real-life conditions
Indication:
Non-resectable or metastatic malignant melanoma stage III/IV according to AJCC with BRAFV600 mutation (patients treated with the vemurafenib/cobimetinib combination according to the information for healthcare professionals)
Status of the study:
Closed
Phase of the study:
Phase IV
Sponsor of the study:
F. Hoffmann-La Roche Ltd.
Study director at Ulm University Hospital:
Prof. M. Huber (until 30.9.2018) PD Dr A. Sindrilaru (from 1.10.2018)
Dermatology study physicians:
Dr D. Crisan,
Title of the study:
Clinical characteristics of the first IMLYGICTM patients with advanced melanoma treated in clinical practice in selected European countries (study protocol number: 20140413)
Indication:
Non-resectable melanoma stage IIIB, IIIC or IVM1a before the first dose of IMLYGICTM
Status of the study:
Closed
Phase of the study:
Phase IV
Sponsor of the study:
Amgen
Study director at Ulm University Hospital:
Prof. M. Huber (until 30.9.2018) PD Dr A. Sindrilaru (from 1.10.2018)
Dermatology study physicians:
Dr N. Treiber, PD Dr A. Sindrilaru
Title of the study:
COMBI-r - a non-interventional, multicentre, prospective study in patients with advanced melanoma to evaluate combination therapy with dabrafenib and trametinib in routine clinical practice
Indication:
Non-resectable or metastatic malignant melanoma stage III/IV according to AJCC with BRAFV600 mutation (patients treated with the dabrafenib + trametinib combination according to the prescribing information)
Status of the study:
Closed
Phase of the study:
Phase IV
Sponsor of the study:
Novartis
Study director at Ulm University Hospital:
Prof. M. Huber (until 30.9.2018) PD Dr A. Sindrilaru (from 1.10.2018)
Dermatology study physicians:
Dr N. Treiber, PD Dr A. Sindrilaru
Title of the study:
ADOreg case registry study (PemNOW) with PD-1 antibody pembrolizumab monotherapy in adult patients with advanced melanoma (unresectable or metastatic)
Indication:
Non-resectable or metastatic malignant melanoma stage III/IV according to AJCC (patients treated with the PD-1 antibody pembrolizumab)
Status of the study:
Recruitment closed
Phase of the study:
Phase IV
Sponsor of the study:
ADO/MSD
Study director at Ulm University Hospital:
Prof Dr M. Huber
Dermatology study physicians:
Dr N. Treiber, PD Dr A. Sindrilaru
Title of the study:
Open-label, multicentre, two-arm, randomised phase III study comparing the efficacy of MEK162 versus dacarbazine in patients with previously untreated advanced unresectable or metastatic NRAS mutation-positive melanoma
Indication:
Non-resectable or metastasised malignant melanoma stage III/IV according to AJCC with NRASQ61 mutation
Status of the study:
Closed
Phase of the study:
Phase III
Sponsor of the study:
Array
Study director at Ulm University Hospital:
Prof. M. Huber (until 30.9.2018) PD Dr A. Sindrilaru (from 1.10.2018)
Deputy:
Dr K. Elsharkawi World
Dermatology study physicians:
Dr N. Treiber
Title of the study:
Randomised, 3-arm, open-label, multicentre phase III study of LGX818 plus MEK162 or LGX818 monotherapy versus vemurafenib in patients with non-resectable or metastatic BRAFV600 mutant melanoma
Indication:
Non-resectable or metastasised malignant melanoma stage III/IV according to AJCC with BRAFV600E/K mutation
Status of the study:
Closed
Phase of the study:
Phase III
Sponsor of the study:
Array
Study director at Ulm University Hospital:
Prof. M. Huber (until 30.9.2018) PD Dr A. Sindrilaru (from 1.10.2018)
Deputy:
Dr K. Elsharkawi World
Dermatology study physicians:
Dr N. Treiber
Title of the study:
Randomised, double-blind phase III study comparing the combination of the BRAF inhibitor dabrafenib and the MEK inhibitor trametinib with dabrafenib and placebo as first-line therapy in patients with unresectable (stage IIIC) or metastatic (stage IV) cutaneous melanoma with BRAFV600E/K mutation
Indication:
Non-resectable or metastasised malignant melanoma stage IIIC/IV according to AJCC BRAFV600E/K mutation
Status of the study:
Recruitment closed
Phase of the study:
Phase III
Sponsor of the study:
Novartis
Study director at Ulm University Hospital:
Prof Dr M. Huber
Deputy:
Dr K. Elsharkawi World
Dermatology study physicians:
Dr N. Treiber
Title of the study:
Phase III randomised, unblinded study comparing GSK2118436 and DTIC in previously untreated patients with advanced (stage III) or metastatic (stage IV) melanoma harbouring the BRAF mutation
Indication:
Non-resectable or metastasised malignant melanoma stage III/IV according to AJCC with BRAFV600 mutation
Status of the study:
Recruitment closed, study closed
Phase of the study:
Phase III
Sponsor of the study:
Novartis
Study director at Ulm University Hospital:
Prof Dr M. Huber
Deputy:
Dr K. Elsharkawi World
Dermatology study physicians:
Dr N. Treiber
Title of the study:
Prospective observational study on the safety of patients with BRAFV600 mutated, unresectable or metastatic melanoma treated with vemurafenib (Zelboraf®)
Indication:
Non-resectable or metastasised malignant melanoma stage III/IV according to AJCC with BRAFV600 mutation (patients treated with the BRAF inhibitor vemurafenib)
Status of the study:
Recruitment closed / study closed (October 2016)
Phase of the study:
Phase IV
Sponsor of the study:
Roche
Study director at Ulm University Hospital:
Prof Dr M. Huber
Dermatology study physicians:
PD Dr L.-A. Schneider, Dr N. Treiber
Title of the study:
International, prospective observational study in patients with non-resectable or metastasised malignant melanoma
Indication:
Non-resectable or metastasised malignant melanoma stage III/IV according to AJCC
Status of the study:
Recruitment closed, study closed
Phase of the study:
Observational study
Sponsor of the study:
BMS
Study director at Ulm University Hospital:
PD Dr L.-A. Schneider
Dermatology study physicians:
Dr S. Kastler
Title of the study:
Early Clinical Trial Unit of the CCCU
Intrathecal application of PD1 antibodies in metastatic solid tumours with leptomeningeal disease
Indication:
Status of the study:
Recruitment closed
Phase of the study:
Sponsor of the study:
Study director at Ulm University Hospital:
Deputy:
Dermatology study physicians:
Title of the study:
Early Clinical Trial Unit of the CCCU
Phase Ia/Ib first-in-human clinical trial to evaluate the safety, tolerability and initial anti-tumour activity of IMA401, a bispecific TCER molecule, in patients with relapsed and/or refractory solid tumours
Indication:
Status of the study:
Phase of the study:
Phase 1a/1b
Sponsor of the study:
Study director at Ulm University Hospital:
Deputy:
Dermatology study physicians: