TVEC and Preop Radiation for Sarcoma (4 ml Dose)
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|ClinicalTrials.gov Identifier: NCT02453191|
Recruitment Status : Active, not recruiting
First Posted : May 25, 2015
Results First Posted : June 17, 2020
Last Update Posted : November 12, 2020
The purpose of this research study is to determine the safety and tolerability of talimogene laherparepvec when combined with radiation therapy.
Approximately 30 people will take part in this study conducted by investigators at the University of Iowa.
|Condition or disease||Intervention/treatment||Phase|
|Soft Tissue Sarcoma||Drug: Talimogene Laherparepvec Radiation: Radiotherapy||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Neoadjuvant Intralesional Injection of Talimogene Laherparepvec With Concurrent Preoperative Radiation in Patients With Locally Advanced Soft Tissue Sarcomas|
|Actual Study Start Date :||July 13, 2015|
|Actual Primary Completion Date :||January 22, 2019|
|Estimated Study Completion Date :||October 16, 2023|
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
Drug: Talimogene Laherparepvec
Concurrent Preoperative Radiation. External Beam Radiation Therapy (EBRT) will be given at the standard dose for resectable soft tissue sarcomas. according to the NCCN sarcoma guidelines.
- Phase 1b: Number of Participants With Dose Limiting Toxicities (DLTs) [ Time Frame: 14 weeks ]A DLT is defined as any of the following talimogene laherparepvec-related toxicity or related to the combination of talimogene laherparepvec and radiation therapy during treatment and up to 4 weeks after the last talimogene laherparepvec injection: Grade 3 or greater immune-mediated adverse events, Grade 3 or greater allergic reactions, any grade plasmacytoma, any other unexpected grade 3 or greater hematologic or non-hematologic toxicity, with the exceptions of: any grade of alopecia, expected radiation related skin toxicity of any grade, Grade 3 arthralgia or myalgia, brief (< 1 week) grade 3 fatigue, Grade 3 fever, Grade 3 diarrhea or vomiting responding to supportive case.
- Phase 2: Number of Subjects With Pathologic Tumor Necrosis ≥ 95% Following Concurrent Radiation Therapy and Talimogene Laherparepvec. [ Time Frame: 14 weeks ]At the end of the neoadjuvant therapy, patients will undergo resection of the treated tumor. The percentage of post treatment tumor necrosis must be documented. The primary end point for this study is pathologic complete response (pCR), and is defined as ≥ 95% tumor necrosis following concurrent radiation therapy and talimogene laherparepvec.
- Overall Response Rate (ORR) as Measured by RECIST [ Time Frame: 24 months ]Overall response rate (ORR) as measured by RECIST 1.1. Complete response is the disappearance of all target lesions.Partial response is a 30% decrease in the sum of the longest dimensions of the target lesions, relative to baseline. Progressive disease is an increase of 20% or more in the sum of the longest dimension of target lesions. Stable disease is a decrease in the tumor size of < 30% or an increase of < 20%..
- Time to Disease Progression (TTP) [ Time Frame: 24 months ]TTP is defined as the time from enrollment until objective tumor progression including local and distant recurrences as measured by RECIST 1.1. Complete response is the disappearance of all target lesions.Partial response is a 30% decrease in the sum of the longest dimensions of the target lesions, relative to baseline. Progressive disease is an increase of 20% or more in the sum of the longest dimension of target lesions. Stable disease is a decrease in the tumor size of < 30% or an increase of < 20%.
- Overall Survival Rate (OS) at 5 Years [ Time Frame: 5 years ]Subjects will be followed for overall survival rate (OS) at 5 years from the last enrollment
- Number of Participants With Adverse Events (AEs) [ Time Frame: 14 weeks ]To further assess the safety of talimogene laherparepvec given concurrently with preoperative external beam radiation in sarcoma patients.Information regarding the occurrence of adverse events will be collected from the time the subject signs the informed consent form and throughout their participation in the study, including a period of 30 days after the last dose of study drug.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02453191
|United States, Iowa|
|University of Iowa Hospitals and Clinics|
|Iowa City, Iowa, United States, 52242|
|Principal Investigator:||Varun Monga, MD||University of Iowa|