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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Awards & highlights
TNT Trial 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.Check my eligibility
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.See study design
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.
TNT Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
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.
Select...
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.
TNT Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Progression free survival
Secondary outcome measures
)verall survival rate
Best overall response and duration of response
Convesion to resectable tumor
+2 moreTNT 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.
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Who is running the clinical trial?
Sarcoma Oncology Research Center, LLCLead Sponsor
7 Previous Clinical Trials
526 Total Patients Enrolled
6 Trials studying Sarcoma
446 Patients Enrolled for Sarcoma
Sant P Chawla, MDPrincipal InvestigatorSarcoma Oncology Center
6 Previous Clinical Trials
444 Total Patients Enrolled
4 Trials studying Sarcoma
364 Patients Enrolled for Sarcoma
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am on medication for an autoimmune disease, not including hormone replacements.I am allergic to TALIMOGENE LAHERPAREPVEC, NIVOLUMAB, or TRABECTEDIN.I need regular medication for herpes, not just cream.My brain metastases are stable, and I'm not on high-dose steroids.I have not received a live vaccine in the last 28 days.My sarcoma cannot be surgically removed or has spread.I am willing to use condoms during and 30 days after treatment.I haven't had cancer in the last 5 years, except for certain skin, cervical, breast, or prostate conditions.I understand the study's risks and have signed the consent form.I haven't had cancer treatment or major surgery in the last 28 days and have recovered from any previous treatments.I am willing and able to follow all study rules and attend all appointments.I agree to avoid close contact with high-risk individuals during and 30 days after my treatment.I am fully active and can carry on all pre-disease activities without restriction.My kidney function is normal, with creatinine levels less than 1.5 times the upper limit.I have a tumor that can be measured and reached for treatment.I have an active hepatitis B infection.My liver functions are within the required range for the trial.I have an active hepatitis C infection.I have a weak immune system due to a condition or medication.I am not pregnant, breastfeeding, nor planning to become pregnant soon.I have been treated with TALIMOGENE LAHERPAREPVEC or another virus-based cancer therapy.I haven't had radiotherapy or certain cancer treatments in the last 14 days, or I've recovered from their side effects.I am not pregnant and agree to use effective birth control during and after the study.I am not willing to use birth control during and for 3 months after treatment.I am 18 years old or older.My blood clotting tests are normal or managed if I'm on blood thinners.
Research Study Groups:
This trial has the following groups:- Group 1: Talimogene laherparepvec, Nivolumab and Trabectedin
Awards:
This trial has 3 awards, including:- 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.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What medical conditions is Talimogene Laherparepvec 100000000 PFU/1 ML Injection Suspension [IMLYGIC] typically prescribed to treat?
"Talimogene Laherparepvec 100000000 PFU/1 ML Injection Suspension [IMLYGIC] is a popular treatment for malignant neoplasms and can also be effective at managing unresectable melanoma, squamous cell carcinoma, as well as metastatic esophageal adenocarcinoma."
Answered by AI
Does this research endeavor currently have any openings for participants?
"As verified on the clinicaltrials.gov platform, this trial is actively enrolling patients at present. It was first brought to attention in May 15th 2019 and underwent its most recent update on October 13th 2022."
Answered by AI
To what degree does Talimogene Laherparepvec 100000000 PFU/1 ML Injection Suspension [IMLYGIC] pose a threat to individuals?
"Our team at Power rated Talimogene Laherparepvec 100000000 PFU/1 ML Injection Suspension [IMLYGIC] as a 2 on their safety scale. This is due to the lack of efficacy data from its Phase 2 trial, though there are some indications that it may be safe for use."
Answered by AI
How many participants constitute the upper limit for this research endeavor?
"Affirmative. According to the clinicaltrials.gov database, this medical investigation is actively seeking participants since its original post date of May 15th 2019 and most recent update on October 13th 2022. The trial requires 40 individuals between one site in order to proceed with the study's procedures."
Answered by AI
What other experiments have been conducted with Talimogene Laherparepvec 100000000 PFU/1 ML Injection Suspension [IMLYGIC]?
"Currently, there are 750 active clinical trials assessing Talimogene Laherparepvec 100000000 PFU/1 ML Injection Suspension [IMLYGIC], with 84 of them in their third phase. 40630 locations across the world have been conducting studies for this drug, many of which take place in Basel BE."
Answered by AI
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