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ENVASARC: Envafolimab And Envafolimab With Ipilimumab In Patients With Undifferentiated Pleomorphic Sarcoma Or Myxofibrosarcoma
Trial Status: closed to accrual
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.
Inclusion Criteria
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
Exclusion Criteria
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
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT04480502.
Locations matching your search criteria
United States
California
Palo Alto
Stanford Cancer Institute Palo Alto
Status: Active
Name Not Available
Illinois
Chicago
Northwestern University
Status: Active
Name Not Available
Maryland
Baltimore
Johns Hopkins University/Sidney Kimmel Cancer Center
Status: Active
Name Not Available
Pennsylvania
Pittsburgh
University of Pittsburgh Cancer Institute (UPCI)
Status: Active
Name Not Available
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
UPS/MFS who have progressed on one or two lines of chemotherapy. Patients were previously
assigned at random into one of two cohorts: cohort A of 80 patients who received single
agent envafolimab (300 mg every 3 weeks by subcutaneous (SC) injection) or cohort B of 80
patients who received envafolimab (300 mg every 3 weeks by SC injection) in combination
with ipilimumab (1 mg/kg every 3 weeks intravenously for four doses). Following amendment
#3, patients will be assigned at random into one of two cohorts: cohort C of 80 patients
who will receive single agent envafolimab (600 mg every 3 weeks by subcutaneous (SC)
injection) or cohort D of 80 patients who will receive envafolimab 600 mg every 3 weeks
by SC injection) in combination with ipilimumab (1 mg/kg every 3 weeks intravenously for
four doses). Following amendment #4, enrollment into cohort D was terminated and no
further interim analyses will be conducted on this cohort.
