Talimogene Laherparepvec, Nivolumab and Trabectedin for Sarcoma

Part of paid clinical trials in Santa Monica, California.

Sponsor
Sarcoma Oncology Research Center, LLC
Study ID
NCT03886311
Phase
PHASE2
Status
Recruiting
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Conditions

  • Sarcoma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • 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

Study Details

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.

Key Dates

Start date
May 15, 2019
Status verified
Feb 2025
Primary completion
Dec 31, 2030
Completion
Jul 31, 2031

Study Design

Enrollment
200 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • 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.

Primary Outcome Measure

Progression free survival [ Time Frame: 12 months ]

Locations (1)

FacilityCityStateZIPSite coordinators
Sarcoma Oncology CenterSanta MonicaCalifornia90403
Victoria Chua
[email protected]
310-552-9999
Sant P Chawla, MD
[email protected]
310-552-9999

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By research site
Sarcoma Oncology Center· Santa Monica, CA

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