WHO ICTRP trial

Study in which melanoma patients are treated with pembrolizumab combined with…

EUCTR2015-003120-31-NL · EU Clinical Trials Register · Authorised

Key facts

Trial ID EUCTR2015-003120-31-NL
Public title Study in which melanoma patients are treated with pembrolizumab combined with dabrafenib and trametinib.
Scientific title Phase 2 Study Comparing Pembrolizumab with Intermittent/Short-term Dual MAPK Pathway Inhibition Plus Pembrolizumab in patients harboring the BRAFV600 mutation (IMPemBra) - IMPemBra
Primary sponsor Antoni van leeuwenhoek ziekenhuis
Registry EU Clinical Trials Register
Recruitment status Authorised
Study type Interventional clinical trial of medicinal product
Phase Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): yes Therapeutic confirmatory - (Phase III): no Therapeutic use (Phase IV): no
Countries Netherlands
Conditions Irresectable stage III and stage IV melanoma MedDRA version: 20.0 Level: LLT Classification code 10027481 Term: Metastatic melanoma System Organ Class: 100000004864 ;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
Interventions Product Name: Pembrolizumab Product Code: MK3475 Pharmaceutical Form: Solution for infusion INN or Proposed INN: PEMBROLIZUMAB CAS Number: 1374853-91-4 Current Sponsor code: MK-3475 Other descriptive name: Anti-PD-1 monoclonal antibody…
Registration date Sep 28, 2015
Target size 32
Secondary IDs N15IMP;NCT02625337
Registry page clinicaltrialsregister.eu

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