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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
ANC >= 1500/uL
Hemoglobin >= 9 g/dL
Must not have
Be younger than 18 years old
Screening 3 weeks
Treatment Varies
Follow Upup to 5 years
Awards & highlights
No Placebo-Only Group

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
  • Soft Tissue Sarcoma
  • Pleomorphic Sarcoma
  • Leiomyosarcoma
  • Liposarcoma
  • Fibrosarcoma

Eligibility Criteria

Inclusion Criteria

You will be eligible if you check “Yes” for the criteria below
You are expected to live for at least 3 months with the right treatment.
Your primary tumor must be bigger than 5cm and located in one place.
You have a type of cancer called sarcoma that can be treated by injecting the medication into the arms, legs, or trunk.
You are able to perform daily activities with a certain level of independence and have a good overall health status.


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

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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.
First Studied
Drug Approval Stage
How many patients have taken this drug
Radiation Therapy
Completed Phase 3
Talimogene Laherparepvec
Completed Phase 3
Completed Phase 4
Biospecimen Collection
Completed Phase 1
Magnetic Resonance Imaging
Completed Phase 3

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor
13,486 Previous Clinical Trials
41,265,897 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.
~8 spots leftby Dec 2024