ENVASARC (Sarcoma) - Clinical Trial

What is the Purpose of this Study?

We are doing this study to see if the study drug, envafolimab, when given alone or in combination with ipilimuma, can stimulate your immune system to attack cancer cells.

We also want to learn more about the effectiveness and safety of the study drug.

What is the Condition Being Studied?

Advanced or metastatic Undifferentiated Pleomorphic Sarcoma (UPS) or Myxofibrosarcoma (MFS)

Who Can Participate in the Study?

-Adults 18+
-Have a diagnosis of locally advanced, unresectable or metastatic UPS or Grade 2 (or higher) MFS

For more information on who can participate in this study please contact the study team.

Age Group
Adults

What is Involved?

If you choose to join this study, you will:
-Have physical exams and blood draws
-Be assigned to either Group 1 or Group 2 (a fair 50/50 chance):
--Group 1 will get the study drug (Envafolimab) once every three weeks on days 1 and 22 of every 42-day cycle through an injection under your skin for about 30 seconds.
--Group 2 will get the study drug (Envafolimab) once every three weeks on days 1 and 22 of every 42-day cycle, and Ipilimumab into your vein once every three weeks on days 1 and 22 of cycles 1 and 2 only

Both groups will:
-Continue to receive follow-up about 28 days after you stop the treatments
-Get a phone call every 3 months after the last dose of medicine to see how you are feeling

Study Details

Full Title
A PIVOTAL TRIAL OF ENVAFOLIMAB, AND ENVAFOLIMAB IN COMBINATION WITH IPILIMUMAB, IN PATIENTS WITH ADVANCED OR METASTATIC UNDIFFERENTIATED PLEOMORPHIC SARCOMA OR MYXOFIBROSARCOMA WHO HAVE PROGRESSED ON PRIOR CHEMOTHERAPY
Principal Investigator
Medical Oncologist
Protocol Number
IRB: PRO00106398
NCT: NCT04480502
Phase
Phase II
ClinicalTrials.gov
Enrollment Status
Open for Enrollment
Participate
Contact the Duke Recruitment Innovation Center
MyResearchPartners@duke.edu
or
919-681-5698