ENVASARC: Envafolimab And Envafolimab With Ipilimumab In Patients With Undifferentiated Pleomorphic Sarcoma Or Myxofibrosarcoma


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Trial ID: NCT04480502


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
Kristen N Ganjoo

Professor of Medicine (Oncology)


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


biological: Envafolimab

drug: Ipilimumab


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Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Amir Emami

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