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
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

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