Any Tumor Type Eligible for Treatment With Talimogene Laherparepvec in Amgen or BioVEX-sponsored Clinical TrialNCT02173171
Registry Study for Talimogene Laherparepvec
An observational study of Any Tumor Type Eligible for Treatment With Talimogene Laherparepvec in Amgen or BioVEX-sponsored Clinical Trial, run by Amgen at 59 sites in 15 countries.
Trial summary
A Registry Study to Evaluate the Survival and Long-Term Safety of Subjects Who Previously Received Talimogene Laherparepvec in Amgen or BioVEX-Sponsored Clinical Trials Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Any Tumor Type Eligible for Treatment With Talimogene Laherparepvec in Amgen or BioVEX-sponsored Clinical Trial
- What is being tested?
- Information collection
- How many people
- 185 participants
- Where
- 59 sitesin 15 countries
- Study dates
- 27 Apr 2010to 23 Sep 2021
- How long will I take part?
- 3 Years
- 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 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Subjects who have received at least one dose of talimogene laherparepvec in an Amgen or BioVEX-sponsored clinical trial.
Who may be able to join
- All subjects must provide informed consent prior to initiation of any study activities.
- All subjects must have received at least one dose of talimogene laherparepvec on an Amgen or BioVEX-sponsored clinical trial for any tumor type and must have discontinued treatment and participation, including long-term follow-up (if applicable) in that trial.
Who cannot join
- Subjects currently receiving talimogene laherparepvec in Amgen or BioVEX-sponsored clinical trial.
- Subject currently participating, including for long-term follow-up (if applicable), in other Amgen-sponsored talimogene laherparepvec clinical trial.
Trial locations and contacts
59 sites in 15 countries.
59 sites in 15 countries
United States26 sites
University of Colorado Cancer Center
Aurora, Colorado, 80045
Gabrail Cancer Center, LLC
Canton, Ohio, 44718
University of North Carolina Chapel Hill
Chapel Hill, North Carolina, 27599
Mary Crowley Cancer Research
Dallas, Texas, 75230
Florida Hospital Memorial Division
Daytona Beach, Florida, 32117
Wheaton Franciscan Healthcare
Franklin, Wisconsin, 53132
The West Clinic PC dba West Cancer Center
Germantown, Tennessee, 38138
Greenville Health System Institute for Translational Oncology Research
Greenville, South Carolina, 29605
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
Investigative Clinical Research of Indiana, LLC
Indianapolis, Indiana, 46260
Baptist MD Anderson Cancer Center
Jacksonville, Florida, 32207
University of Arkansas for Medical Sciences
Little Rock, Arkansas, 72205
Mount Sinai Comprehensive Cancer Center
Miami Beach, Florida, 33140
Allina Health System dba Virginia Piper Cancer Institute
Minneapolis, Minnesota, 55407
University of South Alabama Mitchell Cancer Institute
Mobile, Alabama, 36604
Morristown Medical Center
Morristown, New Jersey, 07962
Intermountain Medical Center
Murray, Utah, 84107
Henry Joyce Cancer Center
Nashville, Tennessee, 37232
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, 08903
Oncology Specialists SC
Park Ridge, Illinois, 60068
Providence Oncology and Hematology Care Eastside
Portland, Oregon, 97213
University of Utah Huntsman Cancer Institute
Salt Lake City, Utah, 84112
St Joseph Heritage Healthcare
Santa Rosa, California, 95403
Saint Louis University Hospital
St Louis, Missouri, 63110
H Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, 33612
Wake Forest Baptist Health Medical Center
Winston-Salem, North Carolina, 27157
Spain4 sites
Hospital Clinic i Provincial de Barcelona
Barcelona, Catalonia, 08036
Onkologikoa
Donostia / San Sebastian, Basque Country, 20014
Hospital Universitario 12 de Octubre
Madrid, 28041
Hospital General Universitario de Valencia
Valencia, Valencia, 46014
Switzerland4 sites
Kantonsspital Graubuenden
Chur, 7000
Hopitaux Universitaires de Geneve
Geneva, 1205
Centre Hospitalier Universitaire Vaudois
Lausanne, 1011
Universitaetsspital Zuerich
Zuerich Flughafen, 8058
Canada3 sites
Tom Baker Cancer Centre
Calgary, Alberta, T2N 4N2
Cross Cancer Institute
Edmonton, Alberta, T6G 1Z2
Princess Margaret Cancer Centre
Toronto, Ontario, M5G 2M9
Greece3 sites
General Hospital of Athens Laiko
Athens, 11527
Metropolitan Hospital
Athens, 18547
Bioclinic of Thessaloniki
Thessaloniki, 54622
Italy3 sites
Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII
Bergamo, 24127
IRCCS Istituto Europeo di Oncologia
Milan, 20141
Azienda Ospedaliera Universitaria Senese Policlinico Le Scotte
Siena, 53100
United Kingdom3 sites
Guys and St Thomas Hospital
London, SE1 9RT
Royal Marsden Hospital
London, SW3 6JJ
The Clatterbridge Cancer Centre NHS Foundation Trust
Metropolitan Borough of Wirral, CH63 4JY
Austria2 sites
Landeskrankenhaus Salzburg
Salzburg, 5020
Universitaetsklinikum Allgemeines Krankenhaus Wien
Vienna, 1090
France2 sites
Hopital Ambroise Pare
Boulogne-Billancourt, 92100
Centre Hospitalier Universitaire de Nantes, Hôpital Hôtel Dieu
Nantes, 44093
Germany2 sites
University Hospital
Heidelberg, 69120
Universitätsklinikum Tübingen
Tübingen, 72076
Hungary2 sites
Pecsi Tudomanyegyetem Klinikai Kozpont
Pécs, 7632
Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont Altalanos Orvostudomanyi Kar
Szeged, 6720
Russia2 sites
FSBI N N Blokhin Russian Oncology Research Center Ministry of Health of Russian Federation
Moscow, 115478
FSBI Scientific and Research Oncology Institute named after N N Petrov
Saint Petersburg, 197758
Poland1 site
Narodowy Instytut Onkologii im Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy
Warsaw, 02-781
South Korea1 site
Yonsei University Health System Severance Hospital
Seoul, 03722
About this study
Official title: A Registry Study to Evaluate the Survival and Long-Term Safety of Subjects Who Previously Received Talimogene Laherparepvec in Amgen or BioVEX-Sponsored Clinical Trials
A Registry Study to Evaluate the Survival and Long-Term Safety of Subjects Who Previously Received Talimogene Laherparepvec in Amgen or BioVEX-Sponsored Clinical Trials
Read the detailed description
A registry study is to evaluate the overall survival, use of subsequent anti-cancer therapy, and the long-term safety of subjects who have received at least one dose of talimogene laherparepvec on an Amgen or BioVEX-sponsored clinical trial for any tumor type. Follow-Up will occur every 3 months.
- Being tested
- Information collection
- Keywords
- Melanoma, talimogene laherparepvec
- Medical subject headings
- Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Information collectionOther
Also called Q3M Information collection
Q3M Information collection
| Study group | Role | What they receive |
|---|---|---|
| Previously treated with T-VEC | Received at least 1 dose of talimogene laherparepvec on Amgen or BioVEX-sponsored clinical trial Receives: Other: Information collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Talimogene Laherparepvec Related Adverse Events
Long-term safety of talimogene laherparepvec will be assessed by reporting of related adverse events every 3 months. Related serious adverse events will be reported within 24 hours following investigator's knowledge of the event.
Measured: 7 years
Subject overall survival
Overall survival status will be reported every 3 months
Measured: 7 years
Use of subsequent anti-cancer therapy
The use of subsequent anti-cancer therapy, for the tumor indication in the prior Amgen or BioVEX-sponsored clinical trial, including retreatment with marketed talimogene laherparepvec for approved indication in subjects previously enrolled in Amgen or BioVEX-sponsored talimogene laherparepvec clinical trials, will be monitored
Measured: 7 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2014 (estimated)
- Study start27 Apr 2010
- Primary completion23 Sep 2021
- Study completion23 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Any Tumor Type Eligible for Treatment With Talimogene Laherparepvec in Amgen or BioVEX-sponsored Clinical TrialStudies of the same condition, open and under way.
- More trials run by AmgenThe 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
- 185 participants (actual)
- Target duration
- 3 Years
Sponsor and investigators
- Lead sponsor
- Amgen
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- MD, Study director, Amgen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02173171
- Sponsor's protocol ID
- 20120139
- Status last verified
- Sep 2021
- First submitted
- 11 Jun 2014
- Last updated
- 30 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Registry Study to Evaluate the Survival and Long-Term Safety of Subjects Who Previously Received Talimogene Laherparepvec in Amgen or BioVEX-Sponsored Clinical Trials
- ClinicalTrials.gov ID
- NCT02173171
- Acronym / sponsor ID
- 20120139
- Keywords
- Melanoma, talimogene laherparepvec
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 185 participants (actual)
- Lead sponsor
- AmgenIndustry (pharma, biotech, devices)
- Study start
- 27 Apr 2010 (actual)
- Primary completion
- 23 Sep 2021 (actual)
- Study completion
- 23 Sep 2021 (actual)
- First posted
- 24 Jun 2014 (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.
A Registry Study to Evaluate the Survival and Long-Term Safety of Subjects Who Previously Received Talimogene Laherparepvec in Amgen or BioVEX-Sponsored Clinical Trials
Detailed description
A registry study is to evaluate the overall survival, use of subsequent anti-cancer therapy, and the long-term safety of subjects who have received at least one dose of talimogene laherparepvec on an Amgen or BioVEX-sponsored clinical trial for any tumor type. Follow-Up will occur every 3 months.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Previously treated with T-VEC | – | Other: Information collectionReceived at least 1 dose of talimogene laherparepvec on Amgen or BioVEX-sponsored clinical trial |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects who have received at least one dose of talimogene laherparepvec in an Amgen or BioVEX-sponsored clinical trial.
Key inclusion criteria (2 listed)
- All subjects must provide informed consent prior to initiation of any study activities.
- All subjects must have received at least one dose of talimogene laherparepvec on an Amgen or BioVEX-sponsored clinical trial for any tumor type and must have discontinued treatment and participation, including long-term follow-up (if applicable) in that trial.
Key exclusion criteria (2 listed)
- Subjects currently receiving talimogene laherparepvec in Amgen or BioVEX-sponsored clinical trial.
- Subject currently participating, including for long-term follow-up (if applicable), in other Amgen-sponsored talimogene laherparepvec clinical trial.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Information collectionAlso: Q3M Information collectionQ3M Information collection | Other | Previously treated with T-VEC |
Primary outcome
Talimogene Laherparepvec Related Adverse Events
Time frame: 7 years
Long-term safety of talimogene laherparepvec will be assessed by reporting of related adverse events every 3 months. Related serious adverse events will be reported within 24 hours following investigator's knowledge of the event.
Subject overall survival
Time frame: 7 years
Overall survival status will be reported every 3 months
Use of subsequent anti-cancer therapy
Time frame: 7 years
The use of subsequent anti-cancer therapy, for the tumor indication in the prior Amgen or BioVEX-sponsored clinical trial, including retreatment with marketed talimogene laherparepvec for approved indication in subjects previously enrolled in Amgen or BioVEX-sponsored talimogene laherparepvec clinical trials, will be monitored
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 30 Sep 2021.
- AmgenTrials clinical trials websiteLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request
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.
MD study director
Amgen
59 sites in 15 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Any Tumor Type Eligible for Treatment With Talimogene Laherparepvec in Amgen or BioVEX-sponsored Clinical Trial, run by Amgen at 59 sites in 15 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 2 inclusion and 2 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 30 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 59 sites in United States, Spain, Switzerland, Canada, Greece and 10 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?
Talimogene Laherparepvec Related Adverse Events (time frame: 7 years). The study lists 3 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 30 Sep 2021; AzTrials last refreshed its copy on 28 Oct 2026.