ENVASARC: Envafolimab And Envafolimab With Ipilimumab In Patients With Undifferentiated Pleomorphic Sarcoma Or Myxofibrosarcoma

Status unconfirmed · Phase 2

Conditions studied: Undifferentiated Pleomorphic Sarcoma, Myxofibrosarcoma

In brief

This is a multicenter open-label, randomized, non-comparative, parallel cohort pivotal study of treatment with envafolimab (cohort A and C) or envafolimab combined with ipilimumab (cohort B and D) in patients with locally advanced, unresectable or metastatic undifferentiated pleomorphic sarcoma (UPS)/myxofibrosarcoma (MFS) who have progressed on one or two lines of chemotherapy.

Key facts

Study ID

NCT04480502

Run by

Tracon Pharmaceuticals Inc.

People needed

207

Starts

2020-12-09

Expected to finish

2024-10-01

Last updated by the study team

2024-05-17

Who can join

Age: 12 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Histologically confirmed locally advanced or metastatic undifferentiated pleomorphic sarcoma (UPS) or grade ≥ 2 myxofibrosarcoma (MFS)
• Documented progression following systemic chemotherapy
• At least one measurable lesion
• Eastern Cooperative Oncology Group performance status of 0 or 1
• Adequate hematologic and organ function

You may not qualify if…

• More than two prior lines of chemotherapy for UPS/MFS
• Prior immune checkpoint inhibitor or immunomodulatory therapy
• Active autoimmune disease that has required systemic treatment
• Major surgery within 4 weeks of dosing of investigational agent
• Active additional malignancy
• Pericardial effusion, pleural effusion, or ascites
• Central nervous system metastases and/or carcinomatous meningitis
• Active hepatitis or cirrhosis
• Interstitial lung disease
• Unwilling to apply highly effective contraception during the study
• Other concurrent severe and/or uncontrolled medical conditions that would, in the investigator's judgment, contraindicate patient participation in the clinical study

Where it is running

• University of Arizona — Tucson, Arizona, United States
• University of California, Los Angeles — Los Angeles, California, United States
• Sarcoma Oncology Research Center — Santa Monica, California, United States
• Stanford University — Stanford, California, United States
• University of Colorado — Aurora, Colorado, United States
• Mayo Clinic, Jacksonville — Jacksonville, Florida, United States
• University of Miami — Miami, Florida, United States
• H. Lee Moffitt Cancer Center — Tampa, Florida, United States
• Northwestern University — Evanston, Illinois, United States
• Johns Hopkins University — Baltimore, Maryland, United States
• Massachusetts General Hospital — Boston, Massachusetts, United States
• Dana Farber Cancer Institute — Boston, Massachusetts, United States
• University of Michigan — Ann Arbor, Michigan, United States
• Mayo Clinic Rochester — Rochester, Minnesota, United States
• Washington University in St. Louis — St Louis, Missouri, United States
• Columbia University — New York, New York, United States
• Memorial Sloan Kettering Cancer Center — New York, New York, United States
• Duke University — Durham, North Carolina, United States
• University Hospitals — Cleveland, Ohio, United States
• Cleveland Clinic — Cleveland, Ohio, United States
• Ohio State University — Columbus, Ohio, United States
• University of Pennsylvania — Philadelphia, Pennsylvania, United States
• Thomas Jefferson University (Sidney Kimmel Cancer Center) — Philadelphia, Pennsylvania, United States
• University of Pittsburgh — Pittsburgh, Pennsylvania, United States
• Vanderbilt University — Nashville, Tennessee, United States

Full record on ClinicalTrials.gov

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