ENVASARC: Envafolimab And Envafolimab With Ipilimumab In Patients With Undifferentiated Pleomorphic Sarcoma Or Myxofibrosarcoma
Purpose
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
- Undifferentiated Pleomorphic Sarcoma
- Myxofibrosarcoma
Eligibility
- Eligible Ages
- Over 12 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
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
Study Design
- Phase
- Phase 2
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Cohort A |
Patients treated with 300 mg of single agent envafolimab every three weeks |
|
|
Experimental Cohort B |
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. |
|
|
Experimental Cohort C |
Patients treated with 600 mg of single agent envafolimab every three weeks |
|
|
Experimental Cohort D |
Patients treated with envafolimab in combination with ipilimumab. Envafolimab will be given at 600 mg every three weeks. Ipilimumab will be given at 1 mg/kg every three weeks for a total of four doses. |
|
Recruiting Locations
Nashville, Tennessee 37235
More Details
- Status
- Recruiting
- Sponsor
- Tracon Pharmaceuticals Inc.
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 patients with locally advanced, unresectable or metastatic UPS/MFS who have progressed on one or two lines of chemotherapy. Patients were previously assigned at random into one of two cohorts: cohort A of 80 patients who received single agent envafolimab (300 mg every 3 weeks by subcutaneous (SC) injection) or cohort B of 80 patients who received envafolimab (300 mg every 3 weeks by SC injection) in combination with ipilimumab (1 mg/kg every 3 weeks intravenously for four doses). Following amendment #3, patients will be assigned at random into one of two cohorts: cohort C of 80 patients who will receive single agent envafolimab (600 mg every 3 weeks by subcutaneous (SC) injection) or cohort D of 80 patients who will receive envafolimab 600 mg every 3 weeks by SC injection) in combination with ipilimumab (1 mg/kg every 3 weeks intravenously for four doses).