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

ZeSS: A Prospective Observational Safety Study of Patients With BRAF-V600 Mutation-positive Unresectable or Metastatic Melanoma Treated With Vemurafenib (Zelboraf®)

NCT01990248•Hoffmann-La Roche

View on ClinicalTrials.gov

Summary

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.

Eligibility

Age

18 - No limit years

Sex

ALL

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

Locations (80)

LKH Feldkirch; Onkologie

Feldkirch, Austria

Ordensklinikum Linz Elisabethinen ; Dermatologie

Linz, Austria

Krankenhaus Hietzing Wien

Vienna, Austria

ZNA Middelheim

Antwerp, Belgium

CHIREC Edith Cavell

Brussels, Belgium

Cliniques Universitaires St-Luc

Brussels, Belgium

UZ Antwerpen

Edegem, Belgium

FN Ostrava; Dermatology dep

Ostrava, Czechia

University Hospital Prague

Prague, Czechia

Komplexni onkologicke centrum Krajske nemocnice T. Bati, a.s. Zlin

Zlín, Czechia

Key Dates

Start Date

March 23, 2013

Primary Completion Date

July 26, 2016

Completion Date

July 26, 2016

Last Updated

June 19, 2018

Enrollment

339

ACTUAL participants

Conditions

Malignant Melanoma

An Phase Ib/II Clinical Trial of TCC1727 Combination Therapy in Advanced Solid Tumors

NCT07371663

Solid CancersNSCLC (Advanced Non-small Cell Lung Cancer)+3 more

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RECRUITINGPHASE1/PHASE2

Modified Vaccine for High Risk or Low Residual Melanoma Patients

NCT01898039

Malignant Melanoma

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: June 19, 2018Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

An Phase Ib/II Clinical Trial of TCC1727 Combination Therapy in Advanced Solid Tumors

Modified Vaccine for High Risk or Low Residual Melanoma Patients

AMT-253 in Patients With Advanced Solid Tumours

Carbon Ion Radiation Therapy in the Treatment of Mucous Melanomas of the Female Lower Genital Tract

Toripalimab Combined With Radiotherapy and Chemotherapy in the Treatment of SNMM After Endoscopic Surgery

Registry of Subjects at Risk of Pancreatic Cancer