Status:
ACTIVE_NOT_RECRUITING
ENVASARC: Envafolimab And Envafolimab With Ipilimumab In Patients With Undifferentiated Pleomorphic Sarcoma Or Myxofibrosarcoma
Lead Sponsor:
Tracon Pharmaceuticals Inc.
Conditions:
Undifferentiated Pleomorphic Sarcoma
Myxofibrosarcoma
Eligibility:
All Genders
12+ years
Phase:
PHASE2
Brief Summary
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 ...
Detailed Description
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 9 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2024
Estimated Enrollment :
207 Patients enrolled
Trial Details
Trial ID
NCT04480502
Start Date
December 9 2020
End Date
October 1 2024
Last Update
May 17 2024
Active Locations (30)
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1
University of Arizona
Tucson, Arizona, United States, 85721
2
University of California, Los Angeles
Los Angeles, California, United States, 90095
3
Sarcoma Oncology Research Center
Santa Monica, California, United States, 90403
4
Stanford University
Stanford, California, United States, 94305