The TNT Protocol: A Phase 2 Study Using Talimogene Laherparepvec,Nivolumab and Trabectedin as First, Second/Third Line Therapy for Advanced Sarcoma, Including Desmoid Tumor and Chordoma
Sarcoma Oncology Research Center, LLC
Summary
This is a Phase 2 study using talimogene laherparepvec, nivolumab, and trabectedin as first, second or third line therapy for advanced sarcoma, including desmoid tumor and chordoma.
Description
This is a Phase 2 study using talimogene laherparepvec, nivolumab, and trabectedin as first, second or third line therapy for advanced sarcoma, including desmoid tumor and chordoma. The primary objective is to determine progression-free survival (PFS) at month 12. The secondary objectives are (1) To evaluate the best overall response (BOR) and duration of response (DOR) by RECIST v1.1 via CT scan or MRI at 6,12,18, and 24 weeks post treatment, (2) To determine progression-free survival rate (PFS) at 6 and 9 months, (3) To determine overall survival rate at 6, 9, and 12 months, (4) To determine…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Individuals must meet all of the inclusion criteria in order to be eligible to participate in the study, as follows: * Male or Female ≥ 18 years of age * Pathologically confirmed diagnosis of locally advanced unresectable or metastatic sarcoma including desmoid tumor and chordoma * Ability to understand the purposes and risks of the study and has signed and dated a written informed consent form approved by the Investigator's IRB/Ethics Committee * Willingness to comply with all study procedures and availability for the duration of the study. * Previously untre…
Interventions
- DrugTalimogene Laherparepvec 100000000 PFU/1 ML Injection Suspension [IMLYGIC]
Talimogene laherparepvec, 1Bil is given intratumorally every 2 weeks according to tumor size
- DrugNivolumab IV Soln 100 MG/10ML
NIVOLUMAB 240 mg IV over 30 min q 2 weeks
- DrugTrabectedin 0.25 MG/1 VIAL Intravenous Powder for Solution
TRABECTEDIN 1.2 mg/m2 CIV over 24 hours q3 weeks
Location
- Sarcoma Oncology CenterSanta Monica, California