Talimogene Laherparepvec, Nivolumab and Trabectedin for Sarcoma

ConditionSarcoma
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorSarcoma Oncology Research Center, LLC

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 volunteers

Qualifiers

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

Design model

Single group

Treatments tested in this trial

  • Talimogene Laherparepvec 100000000 PFU/1 ML Injection Suspension [IMLYGIC]

    Drug

    Talimogene laherparepvec, 1Bil is given intratumorally every 2 weeks according to tumor size

  • Nivolumab IV Soln 100 MG/10ML

    Drug

    NIVOLUMAB 240 mg IV over 30 min q 2 weeks

  • Trabectedin 0.25 MG/1 VIAL Intravenous Powder for Solution

    Drug

    TRABECTEDIN 1.2 mg/m2 CIV over 24 hours q3 weeks

Treatment groups

200 Participants
are divided into 1 treatment group
Group A: Talimogene laherparepvec, Nivolumab and TrabectedinExperimental treatment 3 interventions

Trial outcomes

Primary outcomes

1

Progression free survival

Progression free survival at month 12

Time frame
12 months

Secondary outcomes

1

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

Time frame
12 months
2

Progression free survival rate

Prgoression Free Survival rate at 6 and 9 months

Time frame
Nine months
3

)verall survival rate

Overall survival rate at 6, 9, and 12 months

Time frame
12 months
4

Convesion to resectable tumor

Incidence of conversion of an unresectable tumor to a resectable tumor

Time frame
12 months

Other outcomes

Sponsors and contacts

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