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Registry Study for Talimogene Laherparepvec

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02173171
Recruitment Status : Completed
First Posted : June 24, 2014
Last Update Posted : September 30, 2021
Sponsor:
Information provided by (Responsible Party):
Amgen

Tracking Information
First Submitted Date June 11, 2014
First Posted Date June 24, 2014
Last Update Posted Date September 30, 2021
Actual Study Start Date April 27, 2010
Actual Primary Completion Date September 23, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: October 6, 2017)
  • 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
Original Primary Outcome Measures
 (submitted: June 23, 2014)
  • 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
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Registry Study for Talimogene Laherparepvec
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
Brief 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
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 Type Observational [Patient Registry]
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration 3 Years
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Subjects who have received at least one dose of talimogene laherparepvec in an Amgen or BioVEX-sponsored clinical trial.
Condition Any Tumor Type Eligible for Treatment With Talimogene Laherparepvec in Amgen or BioVEX-sponsored Clinical Trial
Intervention Other: Information collection
Q3M Information collection
Other Name: Q3M Information collection
Study Groups/Cohorts Previously treated with T-VEC
Received at least 1 dose of talimogene laherparepvec on Amgen or BioVEX-sponsored clinical trial
Intervention: Other: Information collection
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: September 17, 2021)
185
Original Estimated Enrollment
 (submitted: June 23, 2014)
450
Actual Study Completion Date September 23, 2021
Actual Primary Completion Date September 23, 2021   (Final data collection date for primary outcome measure)
Eligibility 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 for any tumor type and must have discontinued treatment and participation, including long-term follow-up (if applicable) in that trial.

Exclusion Criteria:

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.

Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 99 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Austria,   Canada,   France,   Germany,   Greece,   Hungary,   Italy,   Korea, Republic of,   Poland,   Russian Federation,   South Africa,   Spain,   Switzerland,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT02173171
Other Study ID Numbers 20120139
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement
Plan to Share IPD: Yes
Plan Description: De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request
Supporting Materials: Study Protocol
Supporting Materials: Statistical Analysis Plan (SAP)
Supporting Materials: Informed Consent Form (ICF)
Supporting Materials: Clinical Study Report (CSR)
Time Frame: Data sharing requests relating to this study will be considered beginning 18 months after the study has ended and either 1) the product and indication (or other new use) have been granted marketing authorization in both the US and Europe or 2) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for this study.
Access Criteria:

Data sharing requests relating to this study will be considered beginning 18 months after the study has ended and either 1) the product and indication (or other new use) have been granted marketing authorization in both the US and Europe or 2) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for this study.

Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen study/studies in scope, endpoints/outcomes of interest, statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling. Requests are reviewed by a committee of internal advisors, and if not approved, may be

URL: https://www.amgen.com/datasharing
Responsible Party Amgen
Study Sponsor Amgen
Collaborators Not Provided
Investigators
Study Director: MD Amgen
PRS Account Amgen
Verification Date September 2021