ZeSS: A Prospective Observational Safety Study of Patients with BRAFV600 Mutation-positive Unresectable or Metastatic Melanoma Treated with Vemurafenib (Zelboraf®)

Study identification

• EU PAS number:
  EUPAS3125
• Study ID:
  21125
• Official title and acronym:
  ZeSS: A Prospective Observational Safety Study of Patients with BRAFV600 Mutation-positive Unresectable or Metastatic Melanoma Treated with Vemurafenib (Zelboraf®)
• DARWIN EU® study:
  No
• Study countries:
  Austria

  Belgium

  Czechia

  Germany

  Ireland

  Italy

  Netherlands

  Poland

  Sweden

  United Kingdom
• Study description:
  This multi-center, prospective, observational safety study will evaluate the safety and effectiveness of Zelboraf (vemurafenib) in a real world setting. Data from Zelboraf-treated patients with BRAF-V600 mutation-positive unresectable or metastatic melanoma will be collected for 2 years.
• Study status:
  Finalised

Research institutions and networks

Institutions

N/A

Multiple centres: 100 centres are involved in the study

Study timelines

Date when funding contract was signed

Planned: 27/04/2012

Actual: 27/04/2012

Study start date

Planned: 25/03/2013

Actual: 22/03/2013

Date of final study report

Planned: 31/03/2017

Actual: 21/03/2017

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

F. Hoffmann-La Roche

Regulatory

• Was the study required by a regulatory body?:
  Yes
• Is the study required by a Risk Management Plan (RMP)?:
  EU RMP category 3 (required)

Other study registration identification numbers and links

GP28492