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Checkpoint Inhibitor

Combination Therapy for Sarcoma (TNT Trial)

Phase 2

Recruiting

Led By Sant P Chawla, MD

Research Sponsored by Sarcoma Oncology Research Center, LLC

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Pathologically confirmed diagnosis of locally advanced unresectable or metastatic sarcoma including desmoid tumor and chordoma

ECOG performance status ≤ 1

Must not have

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.

Subject has known sensitivity to TALIMOGENE LAHERPAREPVEC, NIVOLUMAB or TRABECTEDIN or any of its components to be administered during dosing.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 months

Awards & highlights

All Individual Drugs Already Approved

Approved for 10 Other Conditions

No Placebo-Only Group

Summary

This trial is testing a new combination of drugs to treat advanced sarcoma, including desmoid tumors and chordoma.

Who is the study for?

Adults with advanced sarcoma, including desmoid tumor and chordoma, who are fit (ECOG ≤ 1) and have a life expectancy of at least 3 months. They must be able to understand the study, consent to it, and agree to use effective contraception. Those with certain organ functions within specific limits can join. People with active herpes infections or recent treatments that could interfere are excluded.

What is being tested?

The trial is testing talimogene laherparepvec, nivolumab, and trabectedin as potential first to third line therapies for advanced sarcoma. It's a Phase 2 study where these drugs are given in combination to see how well they work together against this type of cancer.

What are the potential side effects?

Possible side effects include reactions related to immune system activation such as fatigue, flu-like symptoms, skin reactions at the injection site for talimogene laherparepvec; issues like rash or liver function changes from nivolumab; and nausea or blood cell count changes from trabectedin.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My sarcoma cannot be surgically removed or has spread.

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I am fully active and can carry on all pre-disease activities without restriction.

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My kidney function is normal, with creatinine levels less than 1.5 times the upper limit.

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I have a tumor that can be measured and reached for treatment.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am on medication for an autoimmune disease, not including hormone replacements.

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I am allergic to TALIMOGENE LAHERPAREPVEC, NIVOLUMAB, or TRABECTEDIN.

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I need regular medication for herpes, not just cream.

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I am willing to use condoms during and 30 days after treatment.

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I have an active hepatitis B infection.

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I have an active hepatitis C infection.

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I have a weak immune system due to a condition or medication.

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I am not pregnant, breastfeeding, nor planning to become pregnant soon.

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I have been treated with TALIMOGENE LAHERPAREPVEC or another virus-based cancer therapy.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Progression free survival

Secondary study objectives

)verall survival rate

Best overall response and duration of response

Convesion to resectable tumor

+2 more

Awards & Highlights

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Approved for 10 Other Conditions

This treatment demonstrated efficacy for 10 other conditions.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Talimogene laherparepvec, Nivolumab and TrabectedinExperimental Treatment3 Interventions

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.

0 / 13Eligibility criteria met