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A Phase 2 Study of Talimogene Laherparepvec (T-VEC) and Radiation in Localized Soft Tissue Sarcoma
his phase II trial studies the side effects of talimogene laherparepvec and radiation therapy and to see how well they work in treating patients with newly diagnosed soft tissue sarcoma that can be removed by surgery. Biological therapies, such as talimogene laherparepvec, use substances made from living organisms that may stimulate or suppress the immune system in different ways and stop cancer cells from growing. Radiation therapy uses high energy x-rays, photons. electrons, or protons to kill tumor cells and shrink tumors. Giving talimogene laherparepvec and radiation therapy may work better in treating patients with soft tissue sarcoma.
1.1 Primary Objectives 1.1.1 To estimate the pathologic complete necrosis rate (the number of patients with ¡Ý 95% necrosis divided by the number of evaluable patients) following preoperative treatment with talimogene laherparepvec (T-VEC) in combination with radiation in patients with localized soft tissue sarcoma including a pre-planned interim safety analysis to assess post-surgical wound complications. 1.2 Secondary Objectives 1.2.1 To estimate the toxicity of talimogene laherparepvec (T-VEC) in combination with radiation in localized soft tissue sarcomas, during neo-adjuvant treatment and post-surgical resection wound complications. 1.2.2 To estimate the rate of radiologic response, prior to surgery, and extent of surgical resection. 1.2.3 To estimate time to surgery, time to progression, time to recurrence, and death. 1.3 Correlative Objectives 1.3.1 To characterize the clinical outcomes within three distinct histologic subtypes: liposarcoma (excluding myxoid liposarcoma), leiomyosarcoma and undifferentiated pleomorphic sarcoma. 1.3.2 To characterize the percentage of tumor necrosis in treated tumors. 1.3.3 To assess if the combination of preoperative talimogene laherparepvec (T-VEC) with radiation will increase the expression of PD-L1 in soft tissue sarcomas. 1.3.4 To assess the impact of preoperative talimogene laherparepvec (T-VEC) with radiation on the tumor infiltrating and circulating immune cells in patients with soft tissue sarcomas.
Talimogene Laherparepvec (OncoVEX); Talimogene laherparepvec 10^6 PFU (Talimogene Laherparepvec); Talimogene laherparepvec 10^8 PFU (Talimogene Laherparepvec)