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Neoadjuvant Intralesional Injection of Talimogene Laherparepvec

Neoadjuvant Intralesional Injection of Talimogene Laherparepvec With Concurrent Preoperative Radiation in Patients With Locally Advanced Soft Tissue Sarcomas

NCT06660810•John Rieth

View on ClinicalTrials.gov

Summary

The proposed study is designed to treat locally advanced soft tissue sarcoma (STS) subtypes with neoadjuvant talimogene laherparepvec (TVEC) and preoperative external beam radiation therapy (EBRT).

Detailed Description

This is a single-arm open-label phase Ib and phase II clinical study assessing the safety and relative efficacy of concurrent talimogene laherparepvec in combination with radiotherapy in patients with soft tissue sarcomas. Patients will be treated with neoadjuvant radiation and weekly intratumoral injections of talimogene laherparepvec. Weekly injections of talimogene laherparepvec will be continued until surgery. Surgery will be performed 4-6 weeks from the end of radiation therapy to allow for resolution of acute toxicities per current standard of care.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Subject has provided informed consent.
•2. Histologically confirmed diagnosis of locally advanced STS subtypes (including undifferentiated pleomorphic sarcoma, myxofibrosarcoma, and malignant peripheral nerve sheath tumor (MPNST)) that are unresectable with clear wide margins, for which preoperative radiotherapy is considered appropriate.
•EXAMPLES:
•* Resectable stage IIB, III, and IV disease that are not suitable for surgical resection alone due to inability to achieve clear margins.
•* Including metastatic (stage IV) disease for which radiotherapy and surgical resection are indicated.
•* Sarcoma histologies to include: undifferentiated pleomorphic sarcoma (including the terms including, but not limited to pleomorphic undifferentiated sarcoma, unclassified spindle cell sarcoma, spindle cell sarcoma not otherwise specified, pleomorphic spindle cell sarcoma, pleomorphic fibroblastic sarcoma, undifferentiated high-grade pleomorphic sarcoma, pleomorphic sarcoma with prominent inflammation, pleomorphic sarcoma with giant cells, malignant fibrous histiocytoma fibrosarcoma), fibromyxosarcoma, and MPNST
•3. Previous treatment: prior systemic anti-cancer treatment consisting of chemotherapy, immunotherapy, or targeted therapy are allowed provided therapy completed at least1 year prior to enrollment.
•* No prior Talimogene laherparepvec or tumor vaccines allowed.
•* No prior radiation to the same tumor bed allowed.
•4. Age ≥18 years.
+5 more criteria

Exclusion Criteria

•1. Sarcoma histologies that are not consistent with undifferentiated pleomorphic sarcoma, myxofibrosarcoma, or MPNST
•2. History or evidence of sarcoma associated with immunodeficiency states (e.g.:Hereditary immune deficiency, HIV, organ transplant or leukemia).
•3. Subjects with retroperitoneal and visceral sarcoma.
•4. History or evidence of uncontrolled gastrointestinal inflammatory bowel disease (ulcerative colitis or Crohn's disease) or other symptomatic uncontrolled autoimmune disease including, inflammatory bowel disease, or history of any poorly controlled or severe systemic autoimmune disease (i.e., severe rheumatoid arthritis requiring biologic treatment, systemic lupus erythematosus, scleroderma, or autoimmune vasculitis).
•History of other malignancy within the past 3 years except treated with curative intent and no known active disease present and has not received chemotherapy for ≥ 1 year before enrollment/randomization and low risk for recurrence.
•5. History of prior or current splenectomy or splenic irradiation.
•6. Active herpetic skin lesions
•7. Require intermittent or chronic treatment with an anti-herpetic drug (e.g., acyclovir), other than intermittent topical use.
•8. Any non-oncology vaccine therapies used for the prevention of infectious disease within 28 days prior to enrollment and during treatment period.
•9. Concomitant treatment with therapeutic anticoagulants such as warfarin. Patients on therapeutic low molecular weight heparin may be allowed provided the dose can be safely held as per the treating investigator on the morning of scheduled intratumoral injection and can be resumed 12 hours after the procedure.
+24 more criteria

Locations (1)

University of Iowa

Iowa City, Iowa, United States

Key Dates

Start Date

March 3, 2025

Primary Completion Date

June 20, 2025

Completion Date

March 10, 2030

Last Updated

January 15, 2026

Enrollment

ACTUAL participants

Conditions

Soft Tissue SarcomaSarcoma,Soft Tissue

Interventions

Talimogene Laherparepvec

DRUG

Neoadjuvant Radiation

RADIATION

Surgery

PROCEDURE

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 15, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

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Neoadjuvant Intralesional Injection of Talimogene Laherparepvec

Inclusion Criteria

Exclusion Criteria

Actinium Therapy for Late-stage Aggressive Sarcomas

Phase II Study of 5-Day Hypofractionated Preoperative Radiation Therapy for Soft Tissue Sarcomas: Expansion Cohort

Precision Medicine Approaches for Neoadjuvant Therapy in High-risk Sarcoma Patients

Hypofractionated Radiation in Combination With B7-H3-CAR T Cells for Pediatric Patients With Relapsed/Refractory Sarcomas

68Ga-DOTATATE PET/CT for the Diagnosis of Soft Tissue Sarcomas

First-in-Human Study of ADCE-D01 in Soft Tissue Sarcoma