Open
Actively Recruiting
ENVASARC: Envafolimab And Envafolimab With Ipilimumab In Patients With Undifferentiated Pleomorphic Sarcoma Or Myxofibrosarcoma
About
Brief Summary
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.
Primary Purpose
Study Type
Phase
Eligibility
Gender
Healthy Volunteers
Minimum Age
Maximum Age
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
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Study Stats
Protocol No.
20-001550
Category
Sarcoma
Principal Investigator
Contact
Location
- UCLA Santa Monica
- UCLA Westwood