Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03714828 | Study of TVEC in Patients With Cutaneous Squamous Cell Cancer | PHASE2 | COMPLETED | 11 | — | — | Dec 20, 2018 | Jul 19, 2023 | Oct 9, 2024 | 2 | United States |
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...