ENVASARC: Envafolimab And Envafolimab With Ipilimumab In Patients With Undifferentiated Pleomorphic Sarcoma Or Myxofibrosarcoma
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Myxofibrosarcoma
- Undifferentiated Pleomorphic Sarcoma
- Type
- Interventional
- Phase
- Phase 2
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 12 years and 125 years
- Gender
- Both males and females
Description
This is a multicenter open-label, randomized, non-comparative, parallel cohort pivotal study of treatment with envafolimab (cohort A) or envafolimab combined with ipilimumab (cohort B) in patients with locally advanced, unresectable or metastatic UPS/MFS who have progressed on one or two lines of ch...
This is a multicenter open-label, randomized, non-comparative, parallel cohort pivotal study of treatment with envafolimab (cohort A) or envafolimab combined with ipilimumab (cohort B) in patients with locally advanced, unresectable or metastatic UPS/MFS who have progressed on one or two lines of chemotherapy. Patients will be assigned at random into one of the two cohorts: cohort A of 80 patients who will receive single agent envafolimab (300 mg every 3 weeks by subcutaneous (SC) injection) or cohort B of 80 patients who will receive envafolimab (300 mg every 3 weeks by SC injection) in combination with ipilimumab (1 mg/kg every 3 weeks intravenously for four doses).
Tracking Information
- NCT #
- NCT04480502
- Collaborators
- Not Provided
- Investigators
- Study Director: Charles Theuer, MD, PhD Tracon Pharmaceuticals Inc.
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