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Melanoma b-study - Healing Genes
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Melanoma b-study

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Study of TVEC in Patients With Cutaneous Squamous Cell Cancer

A Single Arm Phase 2 Study of Talimogene Laherparepvec in Patients With Cutaneous Squamous Cell Cancer (SCC)


Phase 2

DESCRIPTION:

Doctors at the University of Arizona Cancer Center a seek participants in a clinical investigation of a new treatment for the following skin cancers:

  • Squamous Cell Carcinoma
  • Skin Cancer
  • Keratoacanthoma
  • Cutaneous Tumor
  • Skin Cancer, Squamous Cell
  • Lesion Skin

The investigatory drug, talimogene laherparepvec (also known as OncoVEXGM-CSF or IMLYGIC®), is approved for melanoma, but this study investigates it for less risky skin cancers. The treatment uses a genetically engineered herpes simplex type 1 virus to incite the patient’s immune system to act against tumor cells. This virus infects tumor cells, killing some. It is believed that, when those tumors die, the immune system is prompted to respond and kill more tumor cells.

The study will require injections to the cancerous lesions over the span of 9 to 10 weeks, with follow up for ~11 months.


PATIENT MUST:

  • Be 18 years of age or older
  • Have at least one low risk cutaneous SCC (including keratoacanthomas) meeting the study’s screening requirements for severity and prior treatments
  • Not be pregnant
  • Not have had prior tumor therapy vaccine

THE STUDY INVOLVES:

  1. Prescreening tests to confirm eligibility of the patient to participate.
  2. Initial Imlygic injection to the skin lesion(s) over 1 to 2 weeks
  3. Injection of TVEC into target lesions 3 weeks after 1st injection, then 2 weeks after 2nd injection, then 2 weeks after 3rd injection

LOCATIONS AND CONTACTS:

The study site is at the University of Arizona Cancer Center in Tucson, Arizona. Map.

 

Contact: Amy Selegue  |  (520) 626-0301  |  [email protected]

Contact: Delaney Stratton  |  (520) 626-8483  |  [email protected]

 

SPONSOR INFORMATION:

University of Arizona

Amgen

 

Or go online:

https://clinicaltrials.gov/ct2/show/NCT03714828

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