Neoadjuvant Intralesional Injection of Talimogene Laherparepvec

Phase 2

Recruiting

• Conditions: Soft Tissue Sarcoma; Sarcoma,Soft Tissue
• Interventions: Drug: Talimogene Laherparepvec; Radiation: Neoadjuvant Radiation; Procedure: Surgery

• Registration Number: NCT06660810
• Lead Sponsor: John Rieth

Brief 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.

Study Timeline

• Study First Submitted: 2024-10-25
• Study First Submitted QC: 2024-10-25
• Study First Posted: 2024-10-28
• Study Start: 2025-03-03
• Status Verified: 2025-07
• Last Update Submitted: 2025-07-15
• Last Update Posted: 2025-07-17
• Primary Completion: 2028-11-01
• Study Completion: 2033-11-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Expansion Pilot	Talimogene Laherparepvec	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
Expansion Pilot	Neoadjuvant Radiation	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
Expansion Pilot	Surgery	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

Primary Outcome Measures

Name	Time	Method
pCR rate defined as the proportion of subjects with pathologic necrosis ≥ 90%	Weeks 12-14

Secondary Outcome Measures

Name	Time	Method
Adverse Events will be evaluated according to CTCAE version 4.0	Initiation of treatment through Week 16
ORR defined as the proportion of subjects with a complete or partial response	Initiation of treatment through Week 12
TTP defined as time from first day of study treatment to first documented disease progression	Initiation of treatment through Week 12
Overall Survival defined as time from first day of study treatment to death due to any cause	Initiation of treatment through 5 years

Trial Locations

Locations (1)

University of Iowa; 🇺🇸 Iowa City, Iowa, United States