Purpose of this Study
We are doing this study to find the most effective, safe dose of an experimental drug called INT230-6 (the study drug) in people with recurrent, inoperable, or metastatic soft tissue sarcomas (STS). We also want to know how well it works compared to the usual treatments for people with this diagnosis.
Who Can Participate?
Eligibility
Adults ages 18+ who:
<ul>
<li>Are diagnosed with unresectable, locally advanced, or metastatic STS of one of the following subtypes: liposarcoma (dedifferentiated, myxoid, round cell, or pleomorphic), leiomyosarcoma (non-uterine), or undifferentiated pleomorphic sarcoma</li>
<li>Have received at least one previous line of therapy</li>
<li>Have not received more than 2 lines of therapy for unresectable, locally advanced, or
metastatic STS</li></ul>
For more information about who can join this study, please contact the study team at 919-681-6807.
<ul>
<li>Are diagnosed with unresectable, locally advanced, or metastatic STS of one of the following subtypes: liposarcoma (dedifferentiated, myxoid, round cell, or pleomorphic), leiomyosarcoma (non-uterine), or undifferentiated pleomorphic sarcoma</li>
<li>Have received at least one previous line of therapy</li>
<li>Have not received more than 2 lines of therapy for unresectable, locally advanced, or
metastatic STS</li></ul>
For more information about who can join this study, please contact the study team at 919-681-6807.
Age Range
18-100
Sex/Genders
Male (cisgender)
Female (cisgender)
Non-binary or gender fluid
Transgender male
Transgender female
Looking for Healthy Participants
No
What is Involved?
If you join this study, you will get a random assignment (like drawing numbers from a hat) to either take the study drug or get a standard-of-care (SOC) treatment.
If you get the study drug, you will:
<ul>
<li>Get up to 5 doses of the study drug as an injection every 2 weeks</li>
<li>Continue to get doses of the study drug about every 12 weeks if you are eligible to do so after the first 5 doses</li></ul>
If you get a SOC treatment, you will get one of the 3 following medications that will be chosen by your doctor:
<ul>
<li>Pazopanib: You will take four 200 mg pills by mouth every day</li>
<li>Trabectedin: You will get an intravenous infusion (IV) every 21 days</li>
<li>Eribulin: You will get an intravenous infusion (IV) twice every 21 days</li></ul>
Your participation in this study is expected to last for 24 months, including follow-up checks, if necessary.
The following tests and procedures will be performed throughout the study:
<ul>
<li>Physical exams</li>
<li>Electrocardiogram (ECG), a recording of the electrical activity of your heart</li>
<li>Blood draws and urine samples</li>
<li>Imaging assessments</li>
<li>Questionnaires</li></ul>
If you get the study drug, you will:
<ul>
<li>Get up to 5 doses of the study drug as an injection every 2 weeks</li>
<li>Continue to get doses of the study drug about every 12 weeks if you are eligible to do so after the first 5 doses</li></ul>
If you get a SOC treatment, you will get one of the 3 following medications that will be chosen by your doctor:
<ul>
<li>Pazopanib: You will take four 200 mg pills by mouth every day</li>
<li>Trabectedin: You will get an intravenous infusion (IV) every 21 days</li>
<li>Eribulin: You will get an intravenous infusion (IV) twice every 21 days</li></ul>
Your participation in this study is expected to last for 24 months, including follow-up checks, if necessary.
The following tests and procedures will be performed throughout the study:
<ul>
<li>Physical exams</li>
<li>Electrocardiogram (ECG), a recording of the electrical activity of your heart</li>
<li>Blood draws and urine samples</li>
<li>Imaging assessments</li>
<li>Questionnaires</li></ul>
Locations
Duke University Hospital
Visit Timing
Weekdays
Compensation
No
Spanish Materials Available
No
Study Details
Full Title
A Multicenter, Randomized, Phase 3 Study to Assess the Efficacy and Safety of
INtratumorally Administered INT230-6 (SHAO, VINblastine, CIsplatin) Compared With US Standard of Care in Adult Participants With Locally Recurrent, InoperaBLE, or
Metastatic Soft Tissue Sarcomas - (THE INVINCIBLE-3 TRIAL)
INtratumorally Administered INT230-6 (SHAO, VINblastine, CIsplatin) Compared With US Standard of Care in Adult Participants With Locally Recurrent, InoperaBLE, or
Metastatic Soft Tissue Sarcomas - (THE INVINCIBLE-3 TRIAL)
Principal Investigator
Richard
Riedel
Protocol Number
PRO00115635
NCT ID
NCT06263231
Phase
III
Enrollment Status
Pending Open to Enrollment