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Implementing a Program of Talimogene laherparepvec
Frances Collichio1, Lauren Burke2, Amber Proctor3
1Division of Hematology-Oncology, Department of Medicine, The University of North Carolina, Chapel Hill, NC, USA. fcollich@med.unc.edu.
Background:
Oncolytic viruses are genetically engineered or naturally occurring viruses that selectively replicate in cancer cells without harming normal cells. Talimogene laherparepvec (Imlygic®), the first oncolytic viral therapy approved for treatment of cancer, was approved for treatment of locally advanced melanoma in October 2015.
Purpose:
As a biologic product, use of T. laherparepvec in the clinical setting requires pretreatment planning and a unique systematic approach to deliver the therapy. The processes we describe herein could be adopted by other centers that choose to prescribe T. laherparepvec.
Methods:
We studied our clinical trial experience with T. laherparepvec before we embarked on using commercially available T. laherparepvec. We created a standard operating procedure (SOP) with multidisciplinary buy-in and oversight from leadership in Infection Control at our institution. We reflected on clinical cases and the actual procedures of administering T. laherparepvec to create the SOP.
Results:
The preimplementation planning, patient selection, identification of lesions to treat, the actual procedure, and ongoing assessment of patients are described. Tumoral-related factors that lead to unique challenges are described.
Conclusions:
A process to ensure safe and responsible implementation of a program to administer T. laherparepvec for treatment of melanoma may improve the quality of treatment for patients who suffer from advanced melanoma.
Insights
This study outlines a systematic approach for administering talimogene laherparepvec (Imlygic®), an oncolytic virus therapy, for advanced melanoma treatment. Implementing this process can enhance patient care quality.
Area of Science:
- Oncolytic virotherapy
- Cancer treatment modalities
Background:
- Oncolytic viruses selectively target and replicate in cancer cells.
- Talimogene laherparepvec (Imlygic®) is the first approved oncolytic viral therapy for cancer.
- Approved in 2015, it targets locally advanced melanoma.
Purpose of the Study:
- To describe a systematic approach for the clinical use of talimogene laherparepvec.
- To provide a framework for other institutions prescribing this oncolytic viral therapy.
- To detail pretreatment planning and delivery processes for biologic oncolytic agents.
Main Methods:
- Review of clinical trial experience with talimogene laherparepvec.
- Development of a Standard Operating Procedure (SOP) with multidisciplinary input.
- Reflection on clinical cases and administration procedures to refine the SOP.
Main Results:
- Detailed description of preimplementation planning, patient selection, and lesion identification.
- Explanation of the administration procedure and ongoing patient assessment.
- Identification of tumor-related factors presenting unique challenges.
Conclusions:
- A structured process for administering talimogene laherparepvec ensures safe and responsible implementation.
- This program can potentially improve treatment quality for advanced melanoma patients.
- Standardized protocols are crucial for novel biologic therapies like oncolytic viruses.
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