Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
of TVEC into target lesions- week 1-2 · 1 trial · 6 indications
The primary end point is to evaluate the overall response rate (ORR) defined as proportion of subjects who achieved complete response (CR) and partial response (PR) in the cSCC Target injected lesions (TILs).
| Arm | Type | Description |
|---|---|---|
| Treatment (talimogene laherparepvec) | EXPERIMENTAL | The subject participation period will be approximately 48 weeks. This will include a screening visit, 4 injection visits and 5 follow up visits. Total length of study/patient is 8.5 to 10.5 months. TVEC will be administered by injection with a needle directly into one or more tumors. |
| Name | Type | Description |
|---|---|---|
| Injection of TVEC into target lesions - week 1-2 | DRUG | 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. |
| Injection of TVEC into target lesions 3wks after 1st injection | DRUG | 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. |
| Injection of TVEC into target lesions 2wks after 2nd injection | DRUG | 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. |
| Injection of TVEC into target lesions 2wks after 3rd injection | DRUG | 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. |
Inclusion Criteria: 1. Able to give informed consent in English or Spanish 2. Age \> 18 3. Have at least one \>0.5 cm to \<5.0 cm, histologically confirmed low risk cutaneous SCC (including kerathoacanthomas) * Size \>0.5 cm on trunk or extremities (excluding face, neck feet, nail units, and an...
TVEC is an investigational therapy being studied for the treatment of squamous cell carcinoma, a type of skin cancer. It is administered by injection into target lesions. The drug is currently in Phase 2 clinical development and has not been approved by the FDA.
TVEC is being developed by Amgen Inc., a biotechnology company traded on the NASDAQ under the ticker symbol AMGN. The company is conducting clinical research to evaluate the safety and efficacy of TVEC in patients with squamous cell carcinoma.
TVEC is in Phase 2 clinical development for squamous cell carcinoma. It is an investigational drug, meaning it has not yet received regulatory approval. A Phase 2 study of TVEC in patients with cutaneous squamous cell cancer has been completed.
TVEC has been studied in a Phase 2 clinical trial with the identifier NCT03714828, titled 'Study of TVEC in Patients With Cutaneous Squamous Cell Cancer.' This trial enrolled 11 participants in the United States and has been completed.
TVEC is administered by injection directly into target lesions, which are the cancerous skin lesions in patients with squamous cell carcinoma. This local administration approach is being evaluated in clinical trials to assess its effects on the disease.