Malignant MelanomaNCT01990248
An Observational Safety Study in Zelboraf (Vemurafenib)-Treated Patients With BRAF-V600 Mutation-Positive Unresectable or Metastatic Melanoma (ZeSS)
An observational study of Malignant Melanoma, run by Hoffmann-La Roche at 80 sites in 10 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Malignant Melanoma
- How many people
- 339 participants
- Where
- 80 sitesin 10 countries
- Study dates
- 23 Mar 2013to 26 Jul 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with unresectable or metastatic melanoma treated with vemurafenib
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
80 sites in 10 countries.
80 sites in 10 countries
Germany31 sites
Klinikum Augsburg; Hauttumorzentrum
Augsburg, 86179
Charite- universitatsmedizin Berlin; Med. Klinik mit Schwerpunkt Hamatologie und Onkologie
Berlin, 12200
Ruhr-Universität Bochum; Klinik für Dermatologie und Allergologie
Bochum, 44791
Universitatsklinikum Bonn; Klinisches Studienzentrum Klinik fur Dermatologie
Bonn, 53105
Medizinisches Zentrum
Bonn, 53111
Dermatologisches Zentrum am Elbe Klinikum Buxtehude
Buxtehude, 21614
DRK Krankenhaus Chemnitz-Rabenstein; Hautkrebszentrum Chemnitz
Chemnitz, 09117
Universitätsklinikum "Carl Gustav Carus"; Klinik und Poliklinik fur Dermatologie
Dresden, 01307
Universitätsklinikum Düsseldorf; Hautklinik
Düsseldorf, 40225
Dermatologie und Allergologie HELIOS Hauttumorzentrum Erfurt
Erfurt, 99089
Universitatsklinikum Essen; Klinik für Dermatologie
Essen, 45147
SRH Wald-Klinikum Gera; Zentrum fur klinische Studien (ZKS)
Gera, 07548
Universitaetsmedizin Goettingen; Abteilung Dermato-Onkologie
Göttingen, 37075
Universitätsmedizin Greifswald; Klinik und Poliklinik für Hautkrankheiten
Greifswald, 17487
Univ.- Hautklinik Heidelberg
Heidelberg, 69115
Friedrich-Schiller-Universitaet Jena; Klinik fuer Dermatologie und dermatologische Allergologie
Jena, 07743
Klinikum Kassel GmbH; Hauttumorzentrum HTZ
Kassel, 34125
Studienzentrum UnterEms; Onkologische Schwerpunktpraxis Leer; Dr. med. Lothar Müller
Leer, 26789
UKSH Universitatsklinikum Schleswig-Holstein; Studienzentrum Dermatologie 10d
Lübeck, 23538
Klinikum der Stadt Ludwigshafen am Rhein gGmbH; Hauttumorzentrum Rheinpfalz
Ludwigshafen, 67063
Klinik und Poliklinik fur Dermatologie; Universitatsklinikum Mainz
Mainz, 55131
Med. Fakultat Mannheim der Universitat Heidelberg; Klinik fur Dermatologie
Mannheim, 68167
Johannes Wesling Klinikum Minden;Haut Tumor Centrum Minden
Minden, 32429
Universitätsklinikum Münster; Klinik für Hautkrankheiten; Allgemeine Dermatologie und Venerologie
Münster, 48149
Fachklinik Hornheide; Abteilung für Dermatologie
Münster, 48157
Klinikum Nürnberg Nord; Hautklinik; Klinik für Dermatologie
Nuremberg, 90419
Harzklinikum Dorothea Christiane Erxleben GmbH, Standort Quedlinburg; Hautkrebszentrum Harz
Quedlinburg, 06484
Klinikum Vest; Behandlungszentrum Kanppschaftskrankenhaus Recklinghausen
Recklinghausen, 45657
Universitätsmedizin Rostock; Klinik und Poliklinik für Dermatologie und Venerologie
Rostock, 18057
Eberhard-Karls-Universitat Tubingen; Sektion Dermatologische Onkologie
Tübingen, 72076
Universitätsklinikum Würzburg; Klinik und Poliklinik für Dermatologie Venerologie u. Allergologie
Würzburg, 97080
Italy13 sites
Policlinico S. Orsola Malpighi;Dip. Ematologia, Oncologia e Medicina di Laboratorio
Bologna, Emilia-Romagna, 40138
Ausl Ravenna-Osp.Infermi; Day Hospital Oncologia Medica
Faenza, Emilia-Romagna, 48018
A.U Careggi di Firenze;Oncologia
Florence, Tuscany, 50134
Fondazione IRCCS Istituto Nazionale dei Tumori
Milan, Lombardy, 20133
Asst Grande Ospedale Metropolitano Niguarda; Dipartimento Di Ematologia Ed Oncologia
Milan, Lombardy, 20162
Universita di Modena e Reggio Emilia;Dipartimento di Oncologia ed Ematologia
Modena, Emilia-Romagna, 41100
Istituto Nazionale Tumori Fondazione G. Pascale
Naples, Campania, 80131
Fondazione IRCCS Policlinico San Matteo, Oncologia
Pavia, Lombardy, 27100
Ospedale "Guglielmo da Saliceto";U.O. Medicina Oncologica
Piacenza, Emilia-Romagna, 29121
Azienda Ospedaliero Universitaria Pisana
Pisa, Tuscany, 56100
Azienda ASL di Rimini (Presidi di Rimini - Cattolica)) - Ospedale degli Infermi;U.O. Oncologia
Rimini, Emilia-Romagna, 47922
Azienda Ospedaliera Universitaria Senese, U.O.C. Immunoterapia Oncologica
Siena, Tuscany, 53100
A.O.V.V. - P.O. di Sondrio; S.O.C. Oncologia Medica
Sondrio, Lombardy, 23100
United Kingdom13 sites
Royal Sussex County Hospital
Brighton, BN2 5BE
Bristol Haematology and Oncology Centre
Bristol, BS2 8ED
Addenbrookes Hospital; Dept of Oncology
Cambridge, CB2 2QQ
Velindre Cancer Centre
Cardiff, CF14 2TL
Cheltenham General Hospital; Gloucestershire Oncology Centre
Cheltenham, GL53 7AN
Dorset County Hospital NHS Foundation Trust;Research and Development/ Oncology
Dorchester, DT1 2JY
St James University Hospital
Leeds, LS9 7TF
Guys and St Thomas NHS Foundation Trust, Guys Hospital
London, SE1 9RT
St George's Hospital; Oncology
London, SW17 0QT
Imperial College Healthcare NHS Trust;Medical Oncology
London, W6 8RF
The Clatterbridge Cancer Ctr For Oncolgy
Metropolitan Borough of Wirral, CH63 4JY
St Helens & Knowsley Trust
St Helens, WA9 3DA
New Cross Hospital; Deansley Centre
Wolverhampton, WV10 0QP
Poland6 sites
Centrum Onkologii w Bydgoszczy; Oddzial Kliniczny Onkologii
Bydgoszcz, 85-796
Szpital Uniwersytecki w Krakowie, Oddział Kliniczny Kliniki Onkologii
Krakow, 31-531
RegioNAlny Osrodek Onkologiczny Pododdział Diagnostyki i Terapii Onkologicznej
Lodz, 93-513
Regionalny Osrodek Onkologiczny; Oddzial Chorob Rozrostowych
Lodz, 93-513
Samodzielny Publiczny Zaklad Opieki Zdrowotnej; Opolskie Centrum Onkologii
Opole, 45-060
Centrum Onkologii - Instytut, Klinika Nowotworow Tkanek Miekkich, Kosci i Czerniakow
Warsaw, 02-781
Belgium4 sites
ZNA Middelheim
Antwerp, 2020
CHIREC Edith Cavell
Brussels, 1180
Cliniques Universitaires St-Luc
Brussels, 1200
UZ Antwerpen
Edegem, 2650
Netherlands4 sites
Amphia Ziekenhuis, locatie Langendijk;Oncology
Breda, 4819 EV
Academ Ziekenhuis Groningen; Medical Oncology
Groningen, 9713 GZ
Atrium MC, Parkstad Heerlen; Poli Interne
Heerlen, 6419 PC
Maastricht University Medical Center,Division of Medical Oncology; Dept. Internal Medicine
Maastricht, 6229 HX
Austria3 sites
LKH Feldkirch; Onkologie
Feldkirch, 6800
Ordensklinikum Linz Elisabethinen ; Dermatologie
Linz, 4020
Krankenhaus Hietzing Wien
Vienna, 1130
Czechia3 sites
FN Ostrava; Dermatology dep
Ostrava, 708 52
University Hospital Prague
Prague, 150 06
Komplexni onkologicke centrum Krajske nemocnice T. Bati, a.s. Zlin
Zlín, 760 01
Sweden2 sites
Blekingesjukhuset; Kirurgkliniken
Karlskrona, 371 85
Karolinska University Hospital;Department of Oncology-Pathology
Stockholm, 17176
About this study
Official title: ZeSS: A Prospective Observational Safety Study of Patients With BRAF-V600 Mutation-positive Unresectable or Metastatic Melanoma Treated With Vemurafenib (Zelboraf®)
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.
- Conditions
- Malignant Melanoma
- Medical subject headings
- Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Cohort | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of non-cutaneous squamous cell carcinoma
Measured: 2 years
Incidence of cutaneous squamous cell carcinoma
Measured: 2 years
Incidence of QT prolongation (defined as QTc >500 ms or an increase in QTc >60 ms)
Measured: 2 years
Incidence of abnormal liver function
Measured: 2 years
Secondary outcomes (3)
Incidence of a second (or subsequent) primary melanoma
Measured: 2 years
Incidence of gastrointestinal polyps
Measured: 2 years
Incidence of adverse events
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2013 (estimated)
- Study start23 Mar 2013
- Primary completion26 Jul 2016
- Study completion26 Jul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Malignant MelanomaStudies of the same condition, open and under way.
- More trials run by Hoffmann-La RocheThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 339 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hoffmann-La Roche
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trials, Study director, Hoffmann-La Roche
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01990248
- Sponsor's protocol ID
- GP28492
- Status last verified
- Jun 2018
- First submitted
- 15 Nov 2013
- Last updated
- 19 Jun 2018
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ZeSS: A Prospective Observational Safety Study of Patients With BRAF-V600 Mutation-positive Unresectable or Metastatic Melanoma Treated With Vemurafenib (Zelboraf®)
- ClinicalTrials.gov ID
- NCT01990248
- Acronym / sponsor ID
- GP28492
- Conditions
- Malignant Melanoma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 339 participants (actual)
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- Study start
- 23 Mar 2013 (actual)
- Primary completion
- 26 Jul 2016 (actual)
- Study completion
- 26 Jul 2016 (actual)
- First posted
- 21 Nov 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cohort | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with unresectable or metastatic melanoma treated with vemurafenib
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
3 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jun 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Trials study director
Hoffmann-La Roche
80 sites in 10 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Malignant Melanoma, run by Hoffmann-La Roche at 80 sites in 10 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 80 sites in Germany, Italy, United Kingdom, Poland, Belgium and 5 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of non-cutaneous squamous cell carcinoma (time frame: 2 years). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jun 2018.