Study Summary
This trial is studying the side effects of talimogene laherparepvec and radiation therapy in treating patients with newly diagnosed soft tissue sarcoma.
Eligible Conditions
- Stage IB Soft Tissue Sarcoma
- Stage IA Soft Tissue Sarcoma
- Stage IIA Soft Tissue Sarcoma
- Stage IIB Soft Tissue Sarcoma
- Leiomyosarcoma
- Fibrosarcoma Grade 2
- Stage II Soft Tissue Sarcoma
- Stage I Soft Tissue Sarcoma
- Liposarcoma
- Soft Tissue Sarcoma
- High-Grade Soft Tissue Sarcoma
- Resectable Undifferentiated Pleomorphic Sarcoma
Treatment Effectiveness
Effectiveness Progress
Study Objectives
2 Primary · 7 Secondary · Reporting Duration: Up to 5 years
Baseline to time of surgery
Change in PD-L1 expression
Change in tumor infiltrating and circulating immune cells
Year 5
Time to death
Year 5
Time to progression
Year 5
Time to recurrence
Year 5
Time to surgery
Month 4
Incidence of post-surgical wound complications
Up to 5 years
Clinical outcomes within liposarcoma, leiomyosarcoma, and undifferentiated pleomorphic sarcoma
Incidence of toxicities of T-VEC in combination with radiation therapy
Pathologic complete response (CR) rate
Percentage of tumor necrosis in treated tumors
Rate of radiologic response
Rate of surgical response
Trial Safety
Safety Progress
This is further along than 68% of similar trials
Trial Design
1 Treatment Group
Treatment (talimogene laherparepvec, radiation therapy)
1 of 1
Experimental Treatment
40 Total Participants · 1 Treatment Group
Primary Treatment: Talimogene Laherparepvec · No Placebo Group · Phase 2
Treatment (talimogene laherparepvec, radiation therapy)Experimental Group · 5 Interventions: Magnetic Resonance Imaging, Biopsy, Biospecimen Collection, Talimogene Laherparepvec, Radiation Therapy · Intervention Types: Procedure, Procedure, Procedure, Biological, Radiation
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Magnetic Resonance Imaging
2017
Completed Phase 2
~1100
Biopsy
2014
Completed Phase 4
~1120
Biospecimen Collection
2004
Completed Phase 1
~670
Talimogene laherparepvec
FDA approved
Radiation Therapy
2005
Completed Phase 3
~7010
Trial Logistics
Trial Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: up to 5 years
Who is running the clinical trial?
National Cancer Institute (NCI)Lead Sponsor
13,070 Previous Clinical Trials
41,129,016 Total Patients Enrolled
Steven I RobinsonPrincipal InvestigatorMayo Clinic Cancer Center LAO
Eligibility Criteria
Age 18+ · All Participants · 10 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:You have a diagnosis of leiomyosarcoma.
You have an extremity (upper or lower) that is longer than it is wide.
Patients must have localized disease with a primary tumor > 5 cm by MRI or CT scan.
References
- Goff, Peter H., Laura Riolobos, Bonnie J. LaFleur, Matthew B. Spraker, Y. David Seo, Kimberly S. Smythe, Jean S. Campbell, et al.. 2022. “Neoadjuvant Therapy Induces a Potent Immune Response to Sarcoma, Dominated by Myeloid and B Cells”. Clinical Cancer Research. American Association for Cancer Research (AACR). doi:10.1158/1078-0432.ccr-21-4239.
- 2017. "Talimogene Laherparepvec and Radiation Therapy in Treating Patients With Newly Diagnosed Soft Tissue Sarcoma That Can Be Removed by Surgery". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02923778.
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Conditions
Cancer Related
Treatments