Study of TVEC in Patients With Cutaneous Squamous Cell Cancer

PHASE2CompletedINTERVENTIONAL
Enrollment

11

Participants

Timeline

Start Date

December 20, 2018

Primary Completion Date

July 19, 2023

Study Completion Date

July 19, 2023

Conditions
Squamous Cell CarcinomaSkin CancerKeratoacanthomaCutaneous TumorSkin Cancer, Squamous CellLesion Skin
Interventions
DRUG

Injection of TVEC into target lesions - week 1-2

"Target lesions are identified and documented with measurements and photographs. Photographs will be taken with regional and close up view of the anatomical area and lesion.~Inject 0.5ml - 4ml (based on lesion size - section 7.1, Table 5) Talimogene laherparepvec at nominal concentration of 106 plaque forming units (PFU)/mL with approximately 1.15 mL in a 2 mL vial for the initial dose. This will be administered intralesionally to 1-3 cSCC lesions per anatomical site with a maximum of 5 injectable lesions per patient."

DRUG

Injection of TVEC into target lesions 3wks after 1st injection

"Target lesions are identified and documented with measurements and photographs. Photographs will be taken with global and close up view of the anatomical area and lesion.~Inject 0.5ml - 4ml (based on lesion size) and number of lesions selected. Talimogene laherparepvec at nominal concentration of 108 PFU/mL with approximately 1.15 mL in a 2 mL vial for the second and subsequent doses."

DRUG

Injection of TVEC into target lesions 2wks after 2nd injection

"Target lesions are identified and documented with measurements and photographs. Photographs will be taken with global and close up view of the anatomical area and lesion.~Inject 0.5ml - 4ml (based on lesion size) and number of lesions selected.Talimogene laherparepvec at nominal concentration of 108 PFU/mL with approximately 1.15 mL in a 2 mL vial for the subsequent doses."

DRUG

Injection of TVEC into target lesions 2wks after 3rd injection

"Target lesions are identified and documented with measurements and photographs. Photographs will be taken with global and close up view of the anatomical area and lesion.~Inject 0.5ml - 4ml (based on lesion size) and number of lesions selected. Talimogene laherparepvec at nominal concentration of 108 PFU/mL with approximately 1.15 mL in a 2 mL vial for the subsequent doses."

Trial Locations (2)

85258

Honor Health Research Institute, Scottsdale

85724

University of Arizona Cancer Center, Tucson

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Amgen

INDUSTRY

lead

University of Arizona

OTHER

NCT03714828 - Study of TVEC in Patients With Cutaneous Squamous Cell Cancer | Biotech Hunter | Biotech Hunter