Public trial registry of the CCC-Munich

Trial ADMEC CA184-205

Trial Trial design Status In-/Exclusion Therapy Participants Documents Permissions Tumorboards

Trial
World
Trial acronym
:
ADMEC CA184-205
World
Full title
:

Prospective randomized trial of an adjuvant therapy of completely resected Merkel Cell Carcinoma (MCC) with 3mg/kg BW Ipilimumab (Yervoy®) every 3 weeks for 12 weeks versus observation

World
Description
:

international, explorative, open, prospective, randomized, multicenter Phase-II study

Indication: completely resected Merkel cell carcinoma (MCC)

Timelines Recruitment period:

24 months First patient in (FPI): QII 2014
Last patient in (LPI): QII 2016
End of study: QII 2017 (= 1 year post last patient first treatment)

World
EudraCT number
:
World
Responsible organization
:
KUM - Klinik und Poliklinik für Dermatologie und Allergologie Lmu
Indications
Classification Code Description
ICD-10-GM C44.9 Bösartige Neubildung der Haut, nicht näher bezeichnet
Trial design
World
Blinding type
:
Open
World
Phase
:
II
Status
World
Status
:
Recruitment active
Votes
World
Institutional review board - vote
:
Positive
World
PEI - vote
:
Positive
Initiiation & lock
World
Date of lock (planned / actual)
:
Unknown / Unknown
Participants
Function Prename Surname Organization
World Principal Investigator Carola Berking KUM - Klinik und Poliklinik für Dermatologie und Allergologie Magnifier
World Responsible contact Carola Berking KUM - Klinik und Poliklinik für Dermatologie und Allergologie Magnifier
World Sponsor University of Essen, Department of Dermatology University of Essen, Department of Dermatology Magnifier