This trial is active, not recruiting.

Condition malignant melanoma
Sponsor Hoffmann-La Roche
Start date March 2013
End date July 2016
Trial size 339 participants
Trial identifier NCT01990248, GP28492


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective

Primary Outcomes

Incidence of non-cutaneous squamous cell carcinoma
time frame: 2 years
Incidence of cutaneous squamous cell carcinoma
time frame: 2 years
Incidence of QT prolongation (defined as QTc >500 ms or an increase in QTc >60 ms)
time frame: 2 years
Incidence of abnormal liver function
time frame: 2 years

Secondary Outcomes

Incidence of a second (or subsequent) primary melanoma
time frame: 2 years
Incidence of gastrointestinal polyps
time frame: 2 years
Incidence of adverse events
time frame: 2 years

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title ZeSS: A Prospective Observational Safety Study of Patients With BRAF-V600 Mutation-positive Unresectable or Metastatic Melanoma Treated With Vemurafenib (Zelboraf®)
Trial information was received from ClinicalTrials.gov and was last updated in July 2016.
Information provided to ClinicalTrials.gov by Hoffmann-La Roche.