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Trial record 1 of 1 for:    A Registry Study to Evaluate the Survival and Long-Term Safety of Subjects With Melanoma Who Previously Received Talimogene Laherparepvec
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Registry Study for Talimogene Laherparepvec

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
Amgen
ClinicalTrials.gov Identifier:
NCT02173171
First received: June 11, 2014
Last updated: May 10, 2017
Last verified: May 2017
  Purpose
A Registry Study to Evaluate the Survival and Long-Term Safety of Subjects With Melanoma Who Previously Received Talimogene Laherparepvec

Condition Intervention
Melanoma Other: Information collection

Study Type: Observational [Patient Registry]
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 2 Years
Official Title: A Registry Study to Evaluate the Survival and Long-Term Safety of Subjects With Melanoma Who Previously Received Talimogene Laherparepvec

Resource links provided by NLM:


Further study details as provided by Amgen:

Primary Outcome Measures:
  • 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


Estimated Enrollment: 450
Actual Study Start Date: April 27, 2010
Estimated Study Completion Date: March 23, 2023
Estimated Primary Completion Date: March 23, 2023 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Previously treated with t-vec
Received at least 1 dose on Amgen study.
Other: Information collection
Q3M Information collection
Other Name: Q3M Information collection

Detailed Description:
A Registry Study to Evaluate the Survival and Long-Term Safety of Subjects With Melanoma Who Previously Received at least 1 dose of Talimogene Laherparepvec. FU will occur q3m.
  Eligibility

Ages Eligible for Study:   18 Years to 99 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Subjects who have received at least one dose of talimogene laherparepvec on an Amgen or BioVEX-sponsored clinical trial.
Criteria

Inclusion Criteria:

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 and must have permanently discontinued treatment on that trial.

Exclusion Criteria:

Subjects currently receiving or planning to receive talimogene laherparepvec in the next 30 days.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02173171

  Show 32 Study Locations
Sponsors and Collaborators
Amgen
Investigators
Study Director: MD Amgen
  More Information

Additional Information:
Responsible Party: Amgen
ClinicalTrials.gov Identifier: NCT02173171     History of Changes
Other Study ID Numbers: 20120139
Study First Received: June 11, 2014
Last Updated: May 10, 2017

Keywords provided by Amgen:
Melanoma

Additional relevant MeSH terms:
Melanoma
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Nevi and Melanomas

ClinicalTrials.gov processed this record on June 23, 2017