Actively Recruiting
Talimogene Laherparepvec, Nivolumab and Trabectedin for Sarcoma
Led by Sarcoma Oncology Research Center, LLC · Updated on 2025-02-24
200
Participants Needed
1
Research Sites
637 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Talimogene Laherparepvec, Nivolumab and Trabectedin for Sarcoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female 18 years of age or older
- Pathologically confirmed locally advanced unresectable or metastatic sarcoma including desmoid tumor and chordoma
- Able to understand study purposes and risks and provide written informed consent
- Willing to comply with study procedures and be available for the study duration
- Previously untreated or treated patients with measurable disease by RECIST v1.1 and at least one accessible tumor for intratumoral injection
- ECOG performance status of 0 or 1
- Life expectancy of at least 3 months
- Acceptable liver function: Bilirubin less than 1.5 times upper limit of normal (ULN), except Gilbert Syndrome patients who must have bilirubin less than 3.0 ULN; AST, ALT, and alkaline phosphatase less than 2.5 times ULN (less than 5 times ULN if liver metastases present)
- Acceptable kidney function: Creatinine less than 1.5 times ULN
- Acceptable blood counts: ANC greater than 1500 cells/µL; Platelets greater than 100,000/µL; Hemoglobin greater than 9.0 g/dL
- INR and PT less than 1.5 ULN unless on anticoagulation with therapeutic PT, INR, and aPTT
- Women of childbearing potential must have a negative pregnancy test within 72 hours before enrollment and agree to highly effective contraception during study and for specified months after last dose
You will not qualify if you...
- Active central nervous system metastases, except stable treated brain metastases without progression for at least four weeks
- Active autoimmune disease requiring systemic treatment
- Clinically significant immunosuppression including primary immunodeficiency, opportunistic infections, or systemic immunosuppressive therapy exceeding specified doses
- Active herpetic skin lesions or prior serious HSV-1 complications
- Requirement for systemic antiherpetic drugs other than intermittent topical use
- Previous treatment with talimogene laherparepvec or other oncolytic virus
- Live vaccine within 28 days before study treatment
- Recent immunosuppressive therapy, chemotherapy, radiotherapy overlapping planned injection sites, biological therapy, or major surgery within specified timeframes
- Current participation in another investigational drug or device study or within 28 days since last such treatment
- Known active hepatitis B or C infection
- Known HIV infection
- History of other malignancy within 5 years except certain treated cancers without evidence of disease
- Known sensitivity to study drugs or components
- Pregnancy, breastfeeding, or unwillingness to use effective contraception
- Unwillingness to use condoms during and shortly after treatment to prevent viral transmission
- Unwillingness to minimize exposure of bodily fluids to high-risk individuals during and after treatment
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Sarcoma Oncology Center
Santa Monica, California, United States, 90403
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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