NCT03886311

Talimogene Laherparepvec, Nivolumab and Trabectedin for Sarcoma

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

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: Sarcoma Oncology Research Center, LLC · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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 the incidence of conversion of an unresectable tumor to a resectable tumor, and (5) To evaluate the incidence of adverse events related to TALIMOGENE LAHERPAREPVEC in combination with nivolumab and trabectedin. The exploraratory objective is to correlate response with immune cell trafficking in the tumor microenvironment (TME) of resected tumors. The primary endpoint is Progression free survival at month 12. The secondary endpoints are: 1) 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) PFS rate at 6 and 9 months • Overall survival rate at 6, 9, and 12 months, 3) Incidence of conversion of an unresectable tumor to a resectable tumor, 4) Incidence of adverse events related to TALIMOGENE LAHERPAREPVEC in combination with nivolumab and trabectedin. The exploratory endpoint is correlation of response with immune cell trafficking in the tumor microenvironment of resected tumors. Forty male and female subjects \> 18 years of age, of any ethnicity, with advanced sarcoma, including desmoid tumor and chordoma will be treated.

Conditions

• Sarcoma

Interventions

Type	Name	Description
DRUG	Talimogene Laherparepvec 100000000 PFU/1 ML Injection Suspension [IMLYGIC]	Talimogene laherparepvec, 1Bil is given intratumorally every 2 weeks according to tumor size
DRUG	Nivolumab IV Soln 100 MG/10ML	NIVOLUMAB 240 mg IV over 30 min q 2 weeks
DRUG	Trabectedin 0.25 MG/1 VIAL Intravenous Powder for Solution	TRABECTEDIN 1.2 mg/m2 CIV over 24 hours q3 weeks

Timeline

• Start date: 2019-05-15
• Primary completion: 2030-12-31
• Completion: 2031-07-31
• First posted: 2019-03-22
• Last updated: 2025-02-24

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study