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Talimogene Laherparepvec + Radiation Therapy for Soft Tissue Sarcoma

Phase 2
Waitlist Available
Led By Steven I Robinson
Research Sponsored by National Cancer Institute (NCI)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Newly diagnosed and a histopathologically confirmed potentially resectable soft tissue sarcoma of the extremity or trunk of specific subtypes (liposarcoma, leiomyosarcoma, undifferentiated pleomorphic sarcoma [UPS])
Patients must have localized disease with a primary tumor > 5 cm
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights

Study Summary

This trial is studying the side effects of talimogene laherparepvec and radiation therapy in treating patients with newly diagnosed soft tissue sarcoma.

Who is the study for?
Adults with newly diagnosed, potentially removable soft tissue sarcoma of the extremity or trunk (like liposarcoma or leiomyosarcoma) that's larger than 5 cm and requires radiation before surgery. Participants need normal organ function, no prior cancer treatments causing unresolved side effects, no metastatic disease, not pregnant/breastfeeding, and must agree to use contraception.Check my eligibility
What is being tested?
The trial is testing talimogene laherparepvec combined with radiation therapy on patients who can have their tumors surgically removed. It aims to see if this combination is more effective in treating soft tissue sarcomas compared to standard therapies.See study design
What are the potential side effects?
Possible side effects include reactions at the injection site for talimogene laherparepvec, flu-like symptoms such as fever and chills, fatigue from radiation therapy, and potential risks associated with immune system stimulation which could lead to autoimmune responses.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have a newly diagnosed, operable soft tissue sarcoma in my limbs or trunk.
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My cancer is localized and the main tumor is larger than 5 cm.
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My kidneys are functioning well.
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My cancer needs radiation before surgery.
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I am 18 years old or older.
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My tumor is classified as grade 2 or 3 based on its appearance under a microscope.
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My sarcoma can be reached for injections.
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I am able to care for myself but may not be able to do active work.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Incidence of post-surgical wound complications
Pathologic complete response (CR) rate
Secondary outcome measures
Incidence of toxicities of T-VEC in combination with radiation therapy
Rate of radiologic response
Rate of surgical response
+4 more
Other outcome measures
Change in PD-L1 expression
Change in tumor infiltrating and circulating immune cells
Clinical outcomes within liposarcoma, leiomyosarcoma, and undifferentiated pleomorphic sarcoma
+1 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: Treatment (talimogene laherparepvec, radiation therapy)Experimental Treatment5 Interventions
Patients receive talimogene laherparepvec 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 MRI throughout the trial.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Radiation Therapy
2017
Completed Phase 3
~7250
Talimogene Laherparepvec
2008
Completed Phase 3
~640
Biopsy
2014
Completed Phase 4
~850
Biospecimen Collection
2004
Completed Phase 2
~1730
Magnetic Resonance Imaging
2017
Completed Phase 3
~1190

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor
13,654 Previous Clinical Trials
40,933,113 Total Patients Enrolled
Steven I RobinsonPrincipal InvestigatorMayo Clinic Cancer Center LAO

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
Clinical Cancer ResearchJournal
Neoadjuvant Therapy Induces a Potent Immune Response to Sarcoma, Dominated by Myeloid and B Cells
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.
clinicaltrials.govStudy
Talimogene Laherparepvec and Radiation Therapy in Treating Patients With Newly Diagnosed Soft Tissue Sarcoma That Can Be Removed by Surgery
2019. "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.
All > New Hampshire > Soft Tissue Sarcoma
~5 spots leftby Dec 2024
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