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T-VEC · 1 trial · 2 indications
Pathologic response according to central revision by pathology of NKI (complete response, near complete response (\<10% vital tumor remaining)
| Arm | Type | Description |
|---|---|---|
| T-VEC + Nivolumab | EXPERIMENTAL | Patients will receive pre-surgically 4 courses T-VEC (up to 4ml; first dose 10\^6 PFU per mL, subsequent doses at 10\^8 PFU per mL). Patients will also receive a flatdose of 240mg Nivolumab every 2 weeks after the first T-VEC injections (starting at 2nd T-VEC course at week 3, followed by the next doses at week 5 and 7). |
| Name | Type | Description |
|---|---|---|
| T-VEC | DRUG | The treatment schedule is based on 4 courses of intralesional T-VEC and 3 courses of intraveneous Nivolumab. T-VEC first, in order to achieve the best synergistic effect with influx of CD8+ T-cells prior to the first Nivolumab dose. T-VEC monotherapy with the dose 10\^8 PFU/mL is given every 2 weeks after 3 weeks of the first T-VEC dose (with the first dose of T-VEC 10\^6 PFU/mL to allow for seroconversion), and Nivolumab will be given every 2 weeks. |
Inclusion Criteria: * Adults at least 18 years of age * WHO performance score of 0 or 1 * Cytologically or histologically confirmed diagnosis of stage IIIB/C/D/IVM1a (AJCC 8th edition) melanoma, eligible for surgical resection. * Subjects must have measurable disease according to RECIST 1.1 and mus...
T-VEC is an investigational therapy being studied for use in Stage III melanoma, specifically in patients with resectable early metastatic disease. It is being evaluated as a neo-adjuvant treatment in combination with nivolumab for melanoma that is stage IIIB/C/D or stage IV M1a with injectable disease.
T-VEC is being developed by Amgen Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol AMGN. The company is conducting clinical research to evaluate the therapy's safety and efficacy in melanoma patients.
T-VEC is currently in Phase 2 clinical development. A Phase 2 trial has been completed to evaluate the therapy in combination with nivolumab for the neo-adjuvant treatment of resectable early metastatic melanoma.
T-VEC has been studied in a completed Phase 2 clinical trial registered as NCT04330430. The trial, titled "Neo-adjuvant T-VEC + Nivolumab Combination Therapy for Resectable Early Metastatic (stage IIIB/C/D-IV M1a) Melanoma with Injectable Disease," enrolled 24 participants in the Netherlands.
T-VEC is an investigational drug and is not FDA approved. It is still in clinical development, with a completed Phase 2 trial evaluating its use in combination with nivolumab for the neo-adjuvant treatment of resectable early metastatic melanoma.
T-VEC is being studied in a biomarker-selected patient population. The completed Phase 2 trial enrolled patients with injectable disease, indicating that the study focused on a specific subset of melanoma patients with tumors that could be directly injected.