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

Recruiting
I'm interested

12 years and over
This study is NOT accepting healthy volunteers
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

Undifferentiated Pleomorphic Sarcoma, Myxofibrosarcoma

sarcoma

Charles Theuer, MD, PhD - clinicaltrials@traconpharma.com
Poklepovic, Andrew, S
Phase 2
HM20023448
NCT04480502
See this study on ClinicalTrials.gov

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