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NCT04480502 · ClinicalTrials.gov registry record · Phase 2
ENVASARC: Envafolimab And Envafolimab With Ipilimumab In Patients With Undifferentiated Pleomorphic Sarcoma Or Myxofibrosarcoma
A Phase 2 study of Undifferentiated Pleomorphic Sarcoma and Myxofibrosarcoma, sponsored by Tracon Pharmaceuticals.
- Active
- Registry status
- Phase 2
- Development phase
- 207
- Enrollment target
- 20
- Study locations
NCT04480502: Active Phase 2 study of Undifferentiated Pleomorphic Sarcoma and Myxofibrosarcoma, sponsored by Tracon Pharmaceuticals.
NCT04480502 is a Phase 2 study of Undifferentiated Pleomorphic Sarcoma and Myxofibrosarcoma that is active but no longer recruiting, run by Tracon Pharmaceuticals. The registered enrollment target is 207 participants, above the 73-participant average among 5 other Undifferentiated Pleomorphic Sarcoma trials with a reported enrollment target (184% higher). The trial reports 20 study locations across 13 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04480502, a Phase 2 study of Undifferentiated Pleomorphic Sarcoma and Myxofibrosarcoma, is active but no longer recruiting, sponsored by Tracon Pharmaceuticals.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 207 participants
- Enrollment target
- 20
- Study locations
Study 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 patients with locally advanced, unresectable or metastatic undifferentiated pleomorphic sarcoma (UPS)/myxofibrosarcoma (MFS) who have progressed on one or two lines of chemotherapy.
Conditions Studied
Interventions
- DRUG Ipilimumab
- BIOLOGICAL Envafolimab
Study Locations (20)
California
- University of California, Los Angeles - Los Angeles
- Sarcoma Oncology Research Center - Santa Monica
- Stanford University - Stanford
Florida
- Mayo Clinic, Jacksonville - Jacksonville
- University of Miami - Miami
- H. Lee Moffitt Cancer Center - Tampa
Massachusetts
- Massachusetts General Hospital - Boston
- Dana Farber Cancer Institute - Boston
New York
- Columbia University - New York
- Memorial Sloan Kettering Cancer Center - New York
Ohio
- University Hospitals - Cleveland
- Cleveland Clinic - Cleveland
Arizona
- University of Arizona - Tucson
Colorado
- University of Colorado - Aurora
Illinois
- Northwestern University - Evanston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 207 participants |
| Start Date | 2020-12-09 |
| Est. Completion | 2024-10 |
| Phase | Phase 2 |
What the registry record for NCT04480502 still lists
NCT04480502 is an interventional study that assigns participants to a tested intervention. The registered 207 participants enrollment target is mid-sized for trials with a published cap, above the 73-participant average among 5 other Undifferentiated Pleomorphic Sarcoma trials with a reported enrollment target (184% higher).
The record links to 2 conditions, with Undifferentiated Pleomorphic Sarcoma appearing as the primary indexed condition, and to 2 interventions - of which Ipilimumab is the first listed.
NCT04480502 names 20 study sites across 13 states, led by California, Florida, Massachusetts.
Frequently Asked Questions
What is clinical trial NCT04480502 about?
NCT04480502 is a clinical study titled "ENVASARC: Envafolimab And Envafolimab With Ipilimumab In Patients With Undifferentiated Pleomorphic Sarcoma Or Myxofibrosarcoma". 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...
What is the current status of trial NCT04480502?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 207 participants. The study started on 2020-12-09. Estimated completion is 2024-10.
What conditions does trial NCT04480502 study?
This clinical trial studies the following conditions: Undifferentiated Pleomorphic Sarcoma, Myxofibrosarcoma.
What interventions are being tested in trial NCT04480502?
The interventions under investigation include: Ipilimumab (DRUG), Envafolimab (BIOLOGICAL).
Who is sponsoring clinical trial NCT04480502?
This trial is sponsored by Tracon Pharmaceuticals, which has 16 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04480502 being conducted?
This trial has 20 study locations across Arizona, California, Colorado, Florida, Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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