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

Who is this study for? Patients with Sarcoma
What treatments are being studied? Talimogene Laherparepvec 100000000 PFU/1 ML Injection Suspension [IMLYGIC]+Nivolumab+Trabectedin
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
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• 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 untreated or treated patient with measurable disease by RECIST v1.1, and at least, one accessible tumor for intratumoral injection of TALIMOGENE LAHERPAREPVEC

⁃ ECOG performance status ≤ 1

⁃ Life expectancy of at least 3 months

⁃ Acceptable liver function: Bilirubin \<1.5 times upper limit of normal (ULN; except subjects with Gilbert Syndrome who must have a total bilirubin level \< 3.0 ULN); AST (SGOT), ALT (SGPT) and alk phos \< 2.5 x ULN (\< 5 x ULN if liver metastases present)

⁃ Acceptable renal function: Creatinine \< 1.5 times ULN

⁃ Acceptable hematologic status: ANC \>1500 cells/μL or greater; Platelet count \>100,000/μL or greater; Hemoglobin \> 9.0 g/dL or greater

⁃ INR and PT \< 1.5 ULN unless taking anti-coagulation, in which case PT, INR and aPTT must be within therapeutic range of intended use of anticoagulants

⁃ All women of childbearing potential must have a negative urine or serum pregnancy test within 72 hours of enrollment. If urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required; all subjects must agree to use highly effective means of contraception (surgical sterilization or the use of barrier contraception with either a condom or diaphragm in conjunction with spermicidal gel or an IUD) with their partner from entry into the study through 5 months for women and 7 months for men after the last dose.

Locations
United States
California
Sarcoma Oncology Center
RECRUITING
Santa Monica
Time Frame
Start Date: 2019-05-15
Estimated Completion Date: 2031-07-31
Participants
Target number of participants: 200
Treatments
Experimental: Talimogene laherparepvec, Nivolumab and Trabectedin
This is an open label phase 2 study using known doses of TALIMOGENE LAHERPAREPVEC injected intratumorally, and NIVOLUMAB AND TRABECTEDIN given intravenously.~A total of 40 previously untreated and treated patients will receive TRABECTEDIN 1.2 mg/m2 CIV over 24 hours q3 weeks, NIVOLUMAB 240 mg IV over 30 min q 2 weeks and TALIMOGENE LAHERPAREPVEC intratumorally q 2 weeks according to tumor size (see Schematic of Study Design and Imlygic product information; www.accessdata.fda.gov). Patients in this study may continue treatment until significant disease progression (see below for criteria for discontinuation of therapy) or unacceptable toxicity occurs up to one year of therapy.
Sponsors
Leads: Sarcoma Oncology Research Center, LLC

This content was sourced from clinicaltrials.gov