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Talimogene Laherparepvec for Soft Tissue Sarcoma

Phase 1 & 2
Waitlist Available
Led By Mohammed Milhem, MD
Research Sponsored by University of Iowa
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Resectable stage IIB, III, and IV disease that are not suitable for surgically resection alone due to inability to achieve clear margins.
Including metastatic (stage IV) disease for which radiotherapy and surgical resection are indicated.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 months
Awards & highlights

Study Summary

This trial is testing a new cancer treatment, talimogene laherparepvec, to see if it is safe and works well when combined with radiation.

Eligible Conditions
  • Soft Tissue Sarcoma

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
Your cancer is in stage IIB, III, or IV and cannot be treated with surgery alone because it is too difficult to remove completely.
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You have stage IV cancer that can be treated with radiation therapy or surgery.
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Only certain types of cancers are eligible for this study. GIST, Desmoid, Ewing sarcoma, Kaposi sarcoma, and bone sarcomas are allowed, but other types are not.
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You have received chemotherapy, immunotherapy or targeted therapy for cancer in the past, but it must have been completed at least 1 year before you can enroll in this study.
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You cannot have had radiation treatment in the same area before.

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
Phase 1b: Number of Subjects With Dose Limiting Toxicities (DLTs)
Phase 2: Pathologic Tumor Necrosis Rate
Secondary outcome measures
Number of Participants With Adverse Events (AEs)
Overall Response Rate
Percentage of Participants With 2 Year Overall Survival
+1 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: TreatmentExperimental Treatment2 Interventions
Talimogene Laherparepvec in combination with radiotherapy Talimogene Laherparepvec Dose Levels: • Initial dose for all = talimogene laherparepvec up to 4.0 mL of 106 PFU/mL
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Talimogene Laherparepvec
2008
Completed Phase 3
~640
Radiotherapy
2017
Completed Phase 3
~2610

Find a Location

Who is running the clinical trial?

AmgenIndustry Sponsor
1,355 Previous Clinical Trials
1,384,041 Total Patients Enrolled
University of IowaLead Sponsor
443 Previous Clinical Trials
878,660 Total Patients Enrolled
Mohammed Milhem, MDPrincipal InvestigatorUniversity of Iowa
8 Previous Clinical Trials
233 Total Patients Enrolled

Frequently Asked Questions

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

Are there any analogous investigations that have explored Radiotherapy?

"Currently, 22 research studies are running on Radiotherapy. None of these projects have reached Phase 3 yet. Santa Monica in California is the primary hub for this form of treatment but other clinical sites around the world (242 total) host trials as well."

Answered by AI

How many individuals are partaking in the research being conducted?

"This study is not taking enrolments at the present moment. The trial was initially posted on July 13th 2015 and saw its last update around May 4th 2022. However, if you are still looking for a clinical trial to participate in, there are 443 trials actively recruiting sarcoma patients while 22 studies require participants for radiotherapy-based treatments."

Answered by AI

What is the ultimate purpose of this experiment?

"As stated by Amgen, the clinical trial's primary outcome will be Phase 1b: Number of Participants With Dose Limiting Toxicities (DLTs) and it will be tracked over a 14 week period. Additionally, they intend to measure secondary outcomes including Adverse Events (AEs), Overall Response Rate (ORR) as Measured by RECIST, and Overall Survival Rate (OS). The duration for data collection on OS is 5 years from the last enrollment date."

Answered by AI

Is this medical study pioneering a new approach or has it been done before?

"Radiotherapy has been under the microscope since 2015, when a study sponsored by Amgen was conducted. After this initial research with 30 participants, Radiotherapy achieved Phase 1 and 2 drug approval. At present, 22 active trials are underway across 93 cities in 16 countries."

Answered by AI

Is recruitment of participants still open for this research endeavor?

"This research is not currently in need of participants. The study was posted on July 13th 2015 and last updated May 4th 2022. If you are searching for another trial, 443 studies relating to sarcoma and 22 trials involving radiotherapy are actively taking candidates."

Answered by AI
~3 spots leftby Mar 2025