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ENVASARC: Envafolimab And Envafolimab With Ipilimumab In Patients With Undifferentiated Pleomorphic Sarcoma Or Myxofibrosarcoma
Not Recruiting
Trial ID: NCT04480502
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
Stanford Investigator(s)
Kristen N Ganjoo
Professor of Medicine (Oncology)
Eligibility
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
Intervention(s):
biological: Envafolimab
drug: Ipilimumab
Not Recruiting
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Amir Emami
amir.emami@stanford.edu