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Neoadjuvant Intralesional Injection of Talimogene Laherparepvec

NCT06660810 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 2

Last updated 2026-01-15

No results posted yet for this study

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).

Conditions

  • Soft Tissue Sarcoma
  • Sarcoma,Soft Tissue

Interventions

DRUG

Talimogene Laherparepvec

Talimogene laherparepvec (HSV-1 \[strain JS1\]/ICP34.5-/ICP47-/hGM-CSF) is an oncolytic immunotherapy, formerly known as OncoVEXGM-CSF, an immune-enhanced, oncolytic herpes simplex virus type 1 (HSV-1) Patients will be treated with neoadjuvant radiation and weekly intratumoral injections of talimogene laherparepvec

RADIATION

Neoadjuvant Radiation

Treatment given as a first step to shrink a tumor before the main treatment, which is usually surgery, is given. Patients will be treated with neoadjuvant radiation and weekly intratumoral injections of talimogene laherparepvec

PROCEDURE

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

Sponsors & Collaborators

  • Amgen

    collaborator INDUSTRY

  • John Rieth

    lead OTHER

Principal Investigators

  • John Rieth, MD · University of Iowa

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-03-03
Primary Completion
2025-06-20
Completion
2030-03-10
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06660810 on ClinicalTrials.gov