drugset / Trial / NCT04480502
ENVASARC: Envafolimab And Envafolimab With Ipilimumab In Patients With Undifferentiated Pleomorphic Sarcoma Or Myxofibrosarcoma
RandomizedParallel-groupOpen-labelTreatment
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.
Timeline
- Start
- 2020-12-09
- Primary completion
- 2024-10
- Completion
- 2024-10
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Envafolimab | Monoclonal antibody | 300 mg | Subcutaneous |
| Subject | Envafolimab | Monoclonal antibody | 600 mg | Subcutaneous |
| Subject | Ipilimumab | Monoclonal antibody | 1 mg/kg | Intravenous |