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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

Timeline

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

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You are expected to live for at least 3 months with the right treatment.

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Your primary tumor must be bigger than 5cm and located in one place.

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You have a type of cancer called sarcoma that can be treated by injecting the medication into the arms, legs, or trunk.

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You are able to perform daily activities with a certain level of independence and have a good overall health status.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

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.

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

~630