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TVEC + Radiotherapy for Sarcoma

Phase 1 & 2
Waitlist Available
Led By Mohammed Milhem, MD
Research Sponsored by Varun Monga, MD
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age ≥18 years.
Except certain histologic subtypes: GIST, Desmoid, Ewing sarcoma, Kaposi sarcoma, bone sarcomas and myxoid liposarcomas (Grade 1).
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 months
Awards & highlights

Study Summary

This trial is testing the safety of a new cancer treatment. 46 people will take part in the study at the University of Iowa.

Who is the study for?
Adults with a specific type of cancer called locally advanced soft tissue sarcoma (STS) that can't be completely removed by surgery. They should have tumors at least 5 cm in size suitable for radiation and direct injection or ultrasound-guided therapy. Participants must not have had certain treatments, vaccines, or other clinical trials recently and cannot have autoimmune diseases, active infections like HIV or hepatitis, or severe health issues.Check my eligibility
What is being tested?
The trial is testing the safety and how well people tolerate combining talimogene laherparepvec (a type of oncolytic virus therapy) with radiation therapy in treating STS. About 46 participants will receive this combination treatment to see if it's an effective pre-surgical option.See study design
What are the potential side effects?
Possible side effects include reactions at the injection site, flu-like symptoms such as fever and chills, fatigue, nausea, pain in affected areas due to inflammation caused by the virus attacking cancer cells combined with effects from radiation like skin irritation.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 18 years old or older.
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My cancer is not GIST, Desmoid, Ewing sarcoma, Kaposi sarcoma, bone sarcomas, or Grade 1 myxoid liposarcoma.
Select...
My tumor has not been previously treated with radiation.
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My cancer is at a stage where surgery alone can't remove it all.
Select...
My soft tissue sarcoma cannot be surgically removed and needs preoperative radiotherapy.
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My tumor is at least 5 cm big and can be treated with radiation.
Select...
I can carry out all my self-care but not work activities.
Select...
My cancer has spread and needs radiation or surgery.
Select...
My disease can be treated with injections guided by sight or ultrasound.
Select...
I have not received Talimogene laherparepvec or any cancer vaccines.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of Participants With Dose Limiting Toxicities (DLTs)
Pathologic Tumor Necrosis Rate
Secondary outcome measures
2 Year Overall Survival
2 Year Progression-Free Survival
Overall Response Rate

Side effects data

From 2014 Phase 3 trial • 31 Patients • NCT01368276
67%
Cough
67%
Fatigue
33%
Injection site mass
33%
Influenza like illness
33%
Dyspnoea
33%
Flushing
33%
Chills
33%
Ecchymosis
33%
Urticaria
33%
Diarrhoea
33%
Nausea
33%
Vomiting
33%
Oedema peripheral
33%
Pyrexia
33%
Folliculitis
33%
Oral herpes
33%
Pneumonia
33%
Upper respiratory tract infection
33%
Lipoma
33%
Haemoptysis
33%
Hypopnoea
33%
Oropharyngeal pain
33%
Blood blister
33%
Hyperhidrosis
33%
Night sweats
33%
Pruritus
100%
80%
60%
40%
20%
0%
Study treatment Arm
GM-CSF
Talimogene Laherparepvec

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Talimogene Laherparepvec in combination with radiotherapy-Phase I CohortExperimental Treatment2 Interventions
Talimogene Laherparepvec Dose Levels: Dose 0 = talimogene laherparepvec up to 8.0 mL of 108 PFU/mL dosed weekly Dose -1 = talimogene laherparepvec up to 8.0 mL of 108 PFU/mL dosed every 2 weeks
Group II: Talimogene Laherparepvec in combination with radiotherapy-Phase II CohortActive Control2 Interventions
Dose 0 = talimogene laherparepvec up to 8.0 mL of 108 PFU/mL dosed weekly
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Radiotherapy
2017
Completed Phase 3
~2610
Talimogene Laherparepvec
2008
Completed Phase 3
~640

Find a Location

Who is running the clinical trial?

AmgenIndustry Sponsor
1,370 Previous Clinical Trials
1,377,680 Total Patients Enrolled
Varun Monga, MDLead Sponsor
6 Previous Clinical Trials
128 Total Patients Enrolled
Mohammed MilhemLead Sponsor
6 Previous Clinical Trials
136 Total Patients Enrolled

Media Library

Radiotherapy Clinical Trial Eligibility Overview. Trial Name: NCT04599062 — Phase 1 & 2
Soft Tissue Sarcoma Research Study Groups: Talimogene Laherparepvec in combination with radiotherapy-Phase I Cohort, Talimogene Laherparepvec in combination with radiotherapy-Phase II Cohort
Soft Tissue Sarcoma Clinical Trial 2023: Radiotherapy Highlights & Side Effects. Trial Name: NCT04599062 — Phase 1 & 2
Radiotherapy 2023 Treatment Timeline for Medical Study. Trial Name: NCT04599062 — Phase 1 & 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many subjects are being monitored for this clinical experiment?

"Affirmative, the clinicaltrials.gov website indicates that this trial is accepting applicants - its first listing was on September 10th 2020 and it underwent a modification as recent as October 4th 2022. This experiment requires 46 participants from only one medical facility."

Answered by AI

Is the opportunity to participate in this research endeavor still available?

"According to the listing on clinicaltrials.gov, this clinical trial is actively recruiting participants as of October 4th 2022. It was initially made available for public viewing back on September 10th 2020."

Answered by AI

Is this the initial experiment of its variety?

"Amgen kickstarted the exploration of Talimogene Laherparepvec back in 2015 with a Phase 1 & 2 clinical trial. Since then, 22 live studies have been conducted across 93 cities and 16 countries which resulted in its approval for medical use."

Answered by AI

Could you detail any additional studies that have been implemented with Talimogene Laherparepvec?

"Currently, 22 active studies for Talimogene Laherparepvec are underway with none in the final phase. While the majority of trials take place near Santa Monica, California, 242 sites across America offer clinical research related to this drug."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
TVEC and Preop Radiation for Sarcoma (8 ml Dose)
Mohammed Milhem 2020. "TVEC and Preop Radiation for Sarcoma (8 ml Dose)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04599062.
~2 spots leftby Apr 2025
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