Neoadjuvant Intralesional Injection of Talimogene Laherparepvec

NCT06660810 | Active Not Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: 202402722
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

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).

Conditions

Soft Tissue Sarcoma; Sarcoma,Soft Tissue

Outcome Measures

Primary Outcomes (1)

• pCR rate defined as the proportion of subjects with pathologic necrosis ≥ 90%

  Weeks 12-14

Secondary Outcomes (4)

• 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

Study Arms (1)

Expansion Pilot

EXPERIMENTAL

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

Drug: Talimogene Laherparepvec; Radiation: Neoadjuvant Radiation; Procedure: Surgery

Interventions

Talimogene Laherparepvec DRUG

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

Expansion Pilot

Neoadjuvant Radiation 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

Expansion Pilot

Surgery PROCEDURE

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• Sarcoma histologies that are not consistent with undifferentiated pleomorphic sarcoma, myxofibrosarcoma, or MPNST
• History or evidence of sarcoma associated with immunodeficiency states (e.g.:Hereditary immune deficiency, HIV, organ transplant or leukemia).
• Subjects with retroperitoneal and visceral sarcoma.
• 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.
• History of prior or current splenectomy or splenic irradiation.
• Active herpetic skin lesions
• Require intermittent or chronic treatment with an anti-herpetic drug (e.g., acyclovir), other than intermittent topical use.
• Any non-oncology vaccine therapies used for the prevention of infectious disease within 28 days prior to enrollment and during treatment period.
• 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.
• Known human immunodeficiency virus (HIV) disease (requires negative test for clinically suspected HIV infection).
• Acute or chronic hepatitis B or hepatitis C infection (requires negative test for clinically suspected hepatitis B or hepatitis C infection).
• Evidence of hepatitis B -
• Positive HBV surface antigen (indicative for chronic hepatitis B or recent acute hepatitis B).
• Negative HBV surface antigen but positive HBV total core antibody (indicative for resolved hepatitis B infection or occult hepatitis B) and detectable copies of HBV DNA by PCR (detectable HBV DNA copies suggest occult hepatitis B).

Sponsors & Collaborators

• John Rieth: lead
• Amgen: collaborator

Study Sites (1)

University of Iowa

Iowa City, Iowa, 52242, United States

Location

MeSH Terms

Conditions

Sarcoma

Interventions

talimogene laherparepvec; Neoadjuvant Therapy; Surgical Procedures, Operative

Condition Hierarchy (Ancestors)

Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms

Intervention Hierarchy (Ancestors)

Combined Modality Therapy; Therapeutics

Study Officials

• John Rieth, MD

  University of Iowa

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Clinical Assistant Professor

Study Record Dates

• First Submitted: October 25, 2024
• First Posted: October 28, 2024
• Study Start: March 3, 2025
• Primary Completion: June 20, 2025
• Study Completion (Estimated): March 10, 2030
• Last Updated: January 15, 2026

Record last verified: 2026-01

Locations

US (1)