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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

Must not have

Patients with metastatic disease

Uncontrolled intercurrent illness

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

No Placebo-Only Group

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My cancer has spread to other parts of my body.

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I do not have any unmanaged ongoing illnesses.

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I need medication to prevent blood clots.

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I have not had radiation therapy on the cancer-affected areas.

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My tumor was completely removed, or it came back after complete removal.

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My sarcoma is not located in my limbs or trunk wall.

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I have a condition that causes me to bleed easily.

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I have a serious or non-healing wound, ulcer, or bone fracture.

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I have been treated with T-VEC or another virus-based cancer therapy.

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I have previously been treated with anti-PD1 or anti-CTLA4 therapy.

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I have a grade 1 non-rhabdomyosarcoma soft tissue sarcoma.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Incidence of post-surgical wound complications

Pathologic complete response (CR) rate

Secondary study objectives

Incidence of toxicities of T-VEC in combination with radiation therapy

Rate of radiologic response

Rate of surgical response

+4 more

Other study objectives

Percentage of tumor necrosis in treated tumors

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

Biospecimen Collection

2004

Completed Phase 3

~2030

Biopsy

2014

Completed Phase 4

~1150