Clinical trial · Interventional
ENVASARC: Envafolimab And Envafolimab With Ipilimumab In Patients With Undifferentiated Pleomorphic Sarcoma Or Myxofibrosarcoma
ENVASARC: A Pivotal Trial Of Envafolimab, And Envafolimab In Combination With Ipilimumab, In Patients With Advanced Or Metastatic Undifferentiated Pleomorphic Sarcoma Or Myxofibrosarcoma Who Have Progressed On Prior Chemotherapy
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Myxofibrosarcoma | Myxofibrosarcoma | ONTOLOGY_EXACT | 0.98 |
| Undifferentiated Pleomorphic Sarcoma | Undifferentiated Pleomorphic Sarcoma | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Envafolimab | Biological | — | UNRESOLVED |
| Ipilimumab | Drug | Ipilimumab | ALIAS |
Design
Arms and outcomes
Arms (4)
- type
- EXPERIMENTAL
- label
- Cohort A
- description
- Patients treated with 300 mg of single agent envafolimab every three weeks
- interventionNames
- Biological: Envafolimab
- type
- EXPERIMENTAL
- label
- Cohort B
- description
- Patients treated with envafolimab in combination with ipilimumab. Envafolimab will be given at 300 mg every three weeks. Ipilimumab will be given at 1 mg/kg every three weeks for a total of four doses.
- interventionNames
- Biological: Envafolimab
- Drug: Ipilimumab
- type
- EXPERIMENTAL
- label
- Cohort C
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 12 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available