About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
Known active central nervous system (CNS) metastases. Subjects with previously treated brain metastases may participate provided they are stable (without evidence of progression by imaging for at least four weeks prior to the first dose of trial treatment and any neurologic symptoms have returned to baseline), have no evidence of new or enlarging brain metastases, and are not using steroids >10 mg/day of prednisone or equivalent. The exception does not include carcinomatosus meningitis which is excluded regardless of clinical stability.
History or evidence of active autoimmune disease that requires systemic treatment (ie, with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (eg, thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment.
Evidence of clinically significant immunosuppression such as the following: - Primary immunodeficiency state such as Severe Combined Immunodeficiency Disease. - concurrent opportunistic infection. - receiving systemic immunosuppressive therapy (> 2 weeks) including oral steroid doses > 10 mg/day of prednisone or equivalent within 7 days prior to study treatment.
Active herpetic skin lesions or prior complications of HSV-1 infection (e.g., herpetic keratitis or encephalitis).
Trial design
Single group
Treatments tested in this trial
Talimogene Laherparepvec 100000000 PFU/1 ML Injection Suspension [IMLYGIC]
DrugTalimogene laherparepvec, 1Bil is given intratumorally every 2 weeks according to tumor size
Nivolumab IV Soln 100 MG/10ML
DrugNIVOLUMAB 240 mg IV over 30 min q 2 weeks
Trabectedin 0.25 MG/1 VIAL Intravenous Powder for Solution
DrugTRABECTEDIN 1.2 mg/m2 CIV over 24 hours q3 weeks
Treatment groups
Trial outcomes
Primary outcomes
Progression free survival
Progression free survival at month 12
Secondary outcomes
Best overall response and duration of response
• 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
Progression free survival rate
Prgoression Free Survival rate at 6 and 9 months
)verall survival rate
Overall survival rate at 6, 9, and 12 months
Convesion to resectable tumor
Incidence of conversion of an unresectable tumor to a resectable tumor
Sponsors and contacts
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