NCT02923778

Talimogene Laherparepvec and Radiation Therapy in Treating Patients With Newly Diagnosed Soft Tissue Sarcoma That Can Be Removed by Surgery

A Phase 2 Study of Talimogene Laherparepvec (T-VEC) and Radiation in Localized Soft Tissue Sarcoma

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: National Cancer Institute (NCI) · NIH
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This 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 (resectable). 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.

Detailed description

PRIMARY OBJECTIVE: I. To estimate the pathologic complete necrosis rate (the number of patients with \>= 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. SECONDARY OBJECTIVES: I. 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. II. To estimate the rate of radiologic response, prior to surgery, and extent of surgical resection. III. To estimate time to surgery, time to progression, time to recurrence, and death. CORRELATIVE OBJECTIVES: I. To characterize the clinical outcomes within three distinct histologic subtypes: liposarcoma (excluding myxoid liposarcoma), leiomyosarcoma and undifferentiated pleomorphic sarcoma. II. To characterize the percentage of tumor necrosis in treated tumors. III. To assess if the combination of preoperative talimogene laherparepvec (T-VEC) with radiation will increase the expression of PD-L1 in soft tissue sarcomas. IV. 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. OUTLINE: Patients receive talimogene laherparepvec intratumorally (IT) or via intralesional injection at weeks 1, 4, 6 and 8. Beginning 1 week after the start of talimogene laherparepvec, patients undergo radiation therapy on Monday-Friday of weeks 2-6. Patients undergo collection of blood and a tumor biopsy on study and undergo magnetic resonance imaging (MRI) throughout the trial. After completion of study treatment, patients are followed up every 3 months for 2 years, every 6 months for 3 years, and then every year for up to 5 years.

Conditions

• Leiomyosarcoma
• Liposarcoma
• Sarcoma G2
• Sarcoma G3
• Soft Tissue Sarcoma
• Soft Tissue Sarcoma of the Trunk and Extremities
• Stage I Soft Tissue Sarcoma AJCC v7
• Stage II Soft Tissue Sarcoma AJCC v7
• Undifferentiated Pleomorphic Sarcoma

Interventions

Type	Name	Description
PROCEDURE	Biopsy Procedure	Undergo tumor biopsy
PROCEDURE	Biospecimen Collection	Undergo collection of blood
PROCEDURE	Magnetic Resonance Imaging	Undergo MRI
RADIATION	Radiation Therapy	Undergo radiation therapy
BIOLOGICAL	Talimogene Laherparepvec	Given IT or via intralesional injection

Timeline

• Start date: 2019-12-31
• Primary completion: 2026-12-29
• Completion: 2026-12-29
• First posted: 2016-10-05
• Last updated: 2026-04-13

Locations

17 sites across 2 countries: United States, Canada

Regulatory

• FDA-regulated drug study