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

Official Title

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

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. 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 tumour cells and shrink tumours. Giving talimogene laherparepvec and radiation therapy may work better in treating patients with soft tissue sarcoma.

Trial Description

Primary Outcome:

• Pathologic complete response (CR) rate
• Incidence of post-surgical wound complications

Secondary Outcome:

• Incidence of toxicities of T-VEC in combination with radiation therapy
• Rate of radiologic response
• Rate of surgical response
• Time to surgery
• Time to progression
• Time to recurrence
• Time to death

PRIMARY OBJECTIVE:

• 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:

• 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.
• To estimate the rate of radiologic response, prior to surgery, and extent of surgical resection.
• To estimate time to surgery, time to progression, time to recurrence, and death.

CORRELATIVE OBJECTIVES:

• To characterize the clinical outcomes within three distinct histologic subtypes: liposarcoma (excluding myxoid liposarcoma), leiomyosarcoma and undifferentiated pleomorphic sarcoma.
• To characterize the percentage of tumour necrosis in treated tumours.
• To assess if the combination of preoperative talimogene laherparepvec (T-VEC) with radiation will increase the expression of PD-L1 in soft tissue sarcomas.
• To assess the impact of preoperative talimogene laherparepvec (T-VEC) with radiation on the tumour infiltrating and circulating immune cells in patients with soft tissue sarcomas.

OUTLINE:
Patients receive talimogene laherparepvec intratumourally (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. After completion of study treatment, patients are followed up every 3 months for 2 years, every 6 months for 1 year, and then every year for up to 5 years.

View this trial on ClinicalTrials.gov