MelanomaNCT02910557
Postmarketing Prospective Study of Melanoma Patients Treated With IMLYGIC® to Characterize Risk of Herpetic Infection
An observational study of Melanoma and Herpetic Infection, run by Amgen at 23 sites in 5 countries.
Trial summary
A postmarketing Cohort study of Melanoma patients treated with IMLYGIC (Talimogene Laherparepvec) in clinical Practice to Characterize the risk of herpetic infection with detection of Talimogene Laherparepvec DNA among patients, close contacts, and health care providers; and long term safety in treated patients for up… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Melanoma, Herpetic Infection
- How many people
- 187 participants
- Where
- 23 sitesin 5 countries
- Study dates
- 10 Aug 2017to 30 Jan 2026
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: This postmarketing prospective cohort study will follow melanoma patients for up to 5 years after the first IMLYGIC dose in clinical practice. There is no experimental intervention, and the study population will receive standard-of-care treatment as determined by their treating physician.
Who may be able to join
- Patient has provided written informed consent
- Patient is an adult (≥ 18 years of age at the time of informed consent) with a diagnosis of melanoma
- Patient enrolled within 1 month of receiving the first dose of IMLYGIC for the treatment of melanoma
Who cannot join
- Patient has a prior history of being a subject in an interventional clinical trial for IMLYGIC
Trial locations and contacts
23 sites in 5 countries.
23 sites in 5 countries
United States9 sites
Mercy Medical Center
Baltimore, Maryland, 21202
TriHealth Cancer Institute - Kenwood
Cincinnati, Ohio, 45242
Corazon United States of America, LLC doing business as Life Clinical Trials
Coral Springs, Florida, 33076
Jefferson City Medical Group PC
Jefferson City, Missouri, 65109
University of Tennessee Medical Center
Knoxville, Tennessee, 37920
University of Wisconsin Hospital and Clinics
Madison, Wisconsin, 53792
Intermountain Medical Center
Murray, Utah, 84107
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15213
Allegheny Health Network
Pittsburgh, Pennsylvania, 15224
United Kingdom5 sites
Cheltenham General Hospital
Cheltenham, GL53 7AN
Guys Hospital
London, SE1 9RT
Royal Marsden Hospital
London, SW3 6JJ
Churchill Hospital
Oxford, OX3 7LJ
Musgrove Park Hospital
Taunton, TA1 5DA
Austria4 sites
Medizinische Universitaet Graz
Graz, 8036
Ordensklinikum Linz Elisabethinen
Linz, 4020
Landeskrankenhaus Salzburg
Salzburg, 5020
Universitaetsklinikum Sankt Poelten
Sankt Pölten, 3100
Switzerland3 sites
Universitaetsspital Basel
Basel, 4052
Kantonsspital Graubuenden
Chur, 7000
Universitaetsspital Zuerich
Zuerich Flughafen, 8058
Israel2 sites
Rambam Medical Center
Haifa, 3109601
Sheba Medical Center
Ramat Gan, 5262000
About this study
Official title: A Postmarketing Prospective Cohort Study of Melanoma Patients Treated With IMLYGIC® in Clinical Practice to Characterize Risk of Herpetic Infection Among Patients, Close Contacts, Health Care Providers & Long-term Safety in Treated Patients
A postmarketing Cohort study of Melanoma patients treated with IMLYGIC (Talimogene Laherparepvec) in clinical Practice to Characterize the risk of herpetic infection with detection of Talimogene Laherparepvec DNA among patients, close contacts, and health care providers; and long term safety in treated patients for up to 5 years after the first IMLYGIC dose.
- Conditions
- Melanoma, Herpetic Infection
- Keywords
- IMLYGIC, Talimogene Laherparepvec, Herpetic, Infection Melanoma
- Medical subject headings
- Melanoma
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence Rate
Estimate the incidence rate of herpetic infection with detection of talimogene laherparepvec (T-VEC) DNA among patients for up to 5 years after the first IMLYGIC dose.
Measured: Up to 5 years
Secondary outcomes (9)
Herpectic Infection with T-VEC DNA for Close Contacts and Healthcare Providers (HCPs)
Count the number of herpetic infections with detection of T-VEC DNA among close contacts and HCPs.
Measured: Through study completion, average of 5 years
Incidence of Herpetic Infection with T-VEC in Patients During Treatment
Estimate the incidence rate of herpetic infection with detection of T-VEC DNA among patients during treatment with IMLYGIC.
Measured: Through treatment period, up to 1 year
Incidence of Herpetic Infection with T-VEC in Patients After Treatment
Estimate the incidence rate of herpetic infection with detection of T-VEC DNA among patients after discontinuation of IMLYGIC.
Measured: Through study completion, average of 5 years
Incidence of Herpes Simplex Virus 1 (HSV-1) DNA in Patients During Treatment
Estimate the incidence rate of herpetic infection with detection of wild-type HSV-1 DNA among patients during treatment with IMLYGIC.
Measured: Through treatment period, up to 1 year
Incidence of HSV-1 DNA in Patients After Treatment
Estimate the incidence rate of herpetic infection with detection of wild-type HSV-1 DNA among patients after discontinuation of IMLYGIC.
Measured: Through study completion, average of 5 years
Patient Demographics
The following baseline variables will be recorded: sex, age, Eastern Cooperative Oncology Group (ECOG) performance status.
Measured: Through study completion, average of 5 years
Use of Drug Therapies
Describe the use of IMLYGIC, other anti-cancer therapy, anti-herpetic therapy.
Measured: Through study completion, average of 5 years
Incidence of Adverse Events and Serious Adverse Events in Patients
Incidence of adverse events and serious adverse events during and after treatment with IMLYGIC
Measured: Through study completion, average of 5 years
Overall Survival
Survival is defined by the time to death from the date of the first use of IMLYGIC.
Measured: Through study completion, average of 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2016 (estimated)
- Study start10 Aug 2017
- Primary completion30 Jan 2026
- Study completion30 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MelanomaStudies 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
- 187 participants (actual)
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
- NCT02910557
- Sponsor's protocol ID
- 20130193
- Status last verified
- Feb 2026
- First submitted
- 7 Sep 2016
- Last updated
- 5 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- 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 5 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Postmarketing Prospective Cohort Study of Melanoma Patients Treated With IMLYGIC® in Clinical Practice to Characterize Risk of Herpetic Infection Among Patients, Close Contacts, Health Care Providers & Long-term Safety in Treated Patients
- ClinicalTrials.gov ID
- NCT02910557
- Acronym / sponsor ID
- 20130193
- Conditions
- Melanoma, Herpetic Infection
- Keywords
- IMLYGIC, Talimogene Laherparepvec, Herpetic, Infection Melanoma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 187 participants (actual)
- Lead sponsor
- AmgenIndustry (pharma, biotech, devices)
- Study start
- 10 Aug 2017 (actual)
- Primary completion
- 30 Jan 2026 (actual)
- Study completion
- 30 Jan 2026 (actual)
- First posted
- 22 Sep 2016 (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 postmarketing Cohort study of Melanoma patients treated with IMLYGIC (Talimogene Laherparepvec) in clinical Practice to Characterize the risk of herpetic infection with detection of Talimogene Laherparepvec DNA among patients, close contacts, and health care providers; and long term safety in treated patients for up to 5 years after the first IMLYGIC dose.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- This postmarketing prospective cohort study will follow melanoma patients for up to 5 years after the first IMLYGIC dose in clinical practice. There is no experimental intervention, and the study population will receive standard-of-care treatment as determined by their treating physician.
Key inclusion criteria (3 listed)
- Patient has provided written informed consent
- Patient is an adult (≥ 18 years of age at the time of informed consent) with a diagnosis of melanoma
- Patient enrolled within 1 month of receiving the first dose of IMLYGIC for the treatment of melanoma
Key exclusion criteria (1 listed)
- Patient has a prior history of being a subject in an interventional clinical trial for IMLYGIC
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 Rate
Time frame: Up to 5 years
Estimate the incidence rate of herpetic infection with detection of talimogene laherparepvec (T-VEC) DNA among patients for up to 5 years after the first IMLYGIC dose.
9 secondary outcomes
Herpectic Infection with T-VEC DNA for Close Contacts and Healthcare Providers (HCPs)
Time frame: Through study completion, average of 5 years
Incidence of Herpetic Infection with T-VEC in Patients During Treatment
Time frame: Through treatment period, up to 1 year
Incidence of Herpetic Infection with T-VEC in Patients After Treatment
Time frame: Through study completion, average of 5 years
Incidence of Herpes Simplex Virus 1 (HSV-1) DNA in Patients During Treatment
Time frame: Through treatment period, up to 1 year
Incidence of HSV-1 DNA in Patients After Treatment
Time frame: Through study completion, average of 5 years
Patient Demographics
Time frame: Through study completion, average of 5 years
Use of Drug Therapies
Time frame: Through study completion, average of 5 years
Incidence of Adverse Events and Serious Adverse Events in Patients
Time frame: Through study completion, average of 5 years
Overall Survival
Time frame: Through study completion, average of 5 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 5 Feb 2026.
- 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
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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.
MD study director
Amgen
23 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Melanoma and Herpetic Infection, run by Amgen at 23 sites in 5 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 3 inclusion and 1 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 5 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 23 sites in United States, United Kingdom, Austria, Switzerland, Israel. 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 Rate (time frame: Up to 5 years). 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 5 Feb 2026.