NCT02453191

TVEC and Preop Radiation for Sarcoma (4 ml Dose)

Neoadjuvant Intralesional Injection of Talimogene Laherparepvec With Concurrent Preoperative Radiation in Patients With Locally Advanced Soft Tissue Sarcomas

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: University of Iowa · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this research study is to determine the safety and tolerability of talimogene laherparepvec when combined with radiation therapy. Approximately 30 people will take part in this study conducted by investigators at the University of Iowa.

Detailed description

This is a single-arm open-label phase Ib and phase II clinical study assessing the safety and relative efficacy of concurrent talimogene laherparepvec in combination with radiotherapy in patients with soft tissue sarcomas. Patients will be treated with neoadjuvant radiation and weekly intratumoral injections of talimogene laherparepvec. Weekly injections of talimogene laherparepvec will be continued until surgery. Surgery will be performed 4-6 weeks from the end of radiation therapy to allow for resolution of acute toxicities per current standard of care.

Conditions

• Soft Tissue Sarcoma

Interventions

Type	Name	Description
DRUG	Talimogene Laherparepvec	Talimogene Laherparepvec
RADIATION	Radiotherapy	Concurrent Preoperative Radiation. External Beam Radiation Therapy (EBRT) will be given at the standard dose for resectable soft tissue sarcomas. according to the NCCN sarcoma guidelines.

Timeline

• Start date: 2015-07-13
• Primary completion: 2019-01-22
• Completion: 2023-03-10
• First posted: 2015-05-25
• Last updated: 2024-06-20
• Results posted: 2020-06-17

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study