Study of TVEC in Patients With Cutaneous Squamous Cell Cancer

Summary

This is single arm Phase 2, single center study of talimogene laherparepvec (TVEC) to treat low risk cutaneous squamous cell carcinomas (cSCC).

Conditions

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

Sponsors & Collaborators

• Amgen

  collaborator INDUSTRY

• University of Arizona

  lead OTHER

Principal Investigators

• Clara Curiel, MD · University of Arizona

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2018-12-20

Primary Completion

2023-07-19

Completion

2023-07-19

FDA Drug

Yes

Countries

• United States

Study Locations