ENVASARC: Envafolimab And Envafolimab With Ipilimumab In Patients With Undifferentiated Pleomorphic Sarcoma Or Myxofibrosarcoma
Trial ID or NCT#
Status
RECRUITING
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)
Contact us to find out if this trial is right for you.
Contact
Amir Emami
amir.emami@stanford.edu
View on ClinicalTrials.gov
