Title of the study:
A perioperative phase II and phase III study of fianlimab and cemiplimab versus anti-PD1 monotherapy pembrolizumab in patients with resectable stage III and IV melanoma - ongoing contract negotiations
Indication:
malignant melanoma, resectable, stage III and IV
Status of the study:
Ongoing contract negotiations
Phase of the study:
2 and 3
Sponsor of the study:
Regeneron Pharmaceuticals, Inc.
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:
"A Phase 3, Randomised, Open-label Study to Compare Adjuvant Immunotherapy of Bempegaldesleukin Combined with Nivolumab Versus Nivolumab After Complete Resection of Melanoma in Patients at High Risk for Recurrence (PIVOT-12)"
"A randomised, non-blinded phase 3 trial comparing adjuvant immunotherapy with the combination of bempegaldesleukin and nivolumab versus nivolumab after complete resection of melanoma in patients with malignant melanoma at high risk for recurrence"
Indication:
Malignant melanoma stage IIIA/B/C/D and stage IV according to AJCC, completely surgically treated
Status of the study:
Closed
Phase of the study:
Phase III
Sponsor of the study:
Nektar Therapeutics
Study director at Ulm University Hospital:
Mrs PD Dr med. Anca Sindrilaru
Deputy:
Dr K. Elsharkawi World
Dermatology study physicians:
Dr D Crisan
Title of the study:
" BRAF-/MEK-Inhibition With Dabrafenib and Trametinib in Melanoma Patients in the Adjuvant Setting: a Non-interventional Observatory Study"
"Inhibition of BRAF and MEK with dabrafenib and trametinib as adjuvant therapy in patients with melanoma: a non-interventional observational study"
Indication:
Completely resected, histologically confirmed BRAF V600-mutated cutaneous melanoma in stage III (IIIA, IIIB, IIIC, IIID)
Status of the study:
Closed
Phase of the study:
Phase IV
Sponsor of the study:
EuMelaReg
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:
Combi-AD: A multicentre, double-blind, placebo-controlled phase III study to evaluate the efficacy of the combination of dabrafenib and trametinib in the adjuvant setting in patients with V600E/K mutation after surgical therapy
Indication:
Malignant melanoma stage III according to AJCC, completely surgically treated (R0)
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)
Deputy:
Dr K. Elsharkawi World
Dermatology study physicians:
Dr S. Kastler
Title of the study:
MAGE-A3 study: Double-blind, randomised, placebo-controlled phase III study to assess the efficacy of rec. MAGE-A3 + AS 15 ASCI as adjuvant therapy in patients with MAGE-A3-positive, resected stage III melanoma (AJCC) with macroscopic lymph node involvement
Indication:
Malignant melanoma stage III according to AJCC, completely surgically treated (R0)
Status of the study:
Recruitment closed, study closed
Phase of the study:
Phase III
Sponsor of the study:
GSK
Study director at Ulm University Hospital:
PD Dr L.-A. Schneider
Deputy:
Prof Dr M. Huber
Dermatology study physicians:
Dr S. Kastler