An Observational Safety Study in Zelboraf (Vemurafenib)-Treated Patients With BRAF-V600 Mutation-Positive Unresectable or Metastatic Melanoma (ZeSS)

Roche

Status: Completed

Conditions: Malignant Melanoma

Study type: Observational

Funder types: Industry

Identifiers

NCT01990248

GP28492

Details and patient eligibility

About

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.

Enrollment: 339 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Adult patients of the age of 18 years or older
• Diagnosis of BRAF-V600 mutation-positive unresectable or metastatic melanoma confirmed by a validated test and being treated with vemurafenib
• Vemurafenib treatment must have been initiated at the time of enrollment or no more than one month prior to enrollment
• Patient (or legally acceptable representative) has personally signed and dated the informed consent document indicating that he or she has been informed of all pertinent aspects of the study, if applicable
• Patient is willing to provide information on at least one alternate contact person for study staff to contact regarding the patient's whereabouts, should the patient become lost to follow-up during the course of the study

Exclusion criteria

• Patient was treated with vemurafenib as part of a clinical trial or expanded access program
• Patient has participated in any studies involving any investigational study drug within one month prior to initiating vemurafenib treatment
• Patient has any significant history of disease of medical condition (except metastatic melanoma) which in the judgment of the investigator has the potential to impact participation on the study

Trial design

339 participants in 1 patient group

Cohort