ENVASARC: Envafolimab And Envafolimab With Ipilimumab In Patients With Undifferentiated Pleomorphic Sarcoma Or Myxofibrosarcoma
Trial ID or NCT#
Status
Purpose
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.
Official Title
ENVASARC: 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
Eligibility 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
- * 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
Investigator(s)
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Contact
Amir Emami
amir.emami@stanford.edu
View on ClinicalTrials.gov