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 undifferentiated pleomorphic
sarcoma (UPS)/myxofibrosarcoma (MFS) who have progressed on one or two lines of chemotherapy.
Title
- Brief Title: ENVASARC: Envafolimab And Envafolimab With Ipilimumab In Patients With Undifferentiated Pleomorphic Sarcoma Or Myxofibrosarcoma
- Official Title: 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
Clinical Trial IDs
- ORG STUDY ID:
KN035SAR201
- NCT ID:
NCT04480502
Conditions
- Undifferentiated Pleomorphic Sarcoma
- Myxofibrosarcoma
Interventions
Drug | Synonyms | Arms |
---|
Envafolimab | KN035 | Envafolimab |
Ipilimumab | Yervoy | Envafolimab + Ipilimumab |
Purpose
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 undifferentiated pleomorphic
sarcoma (UPS)/myxofibrosarcoma (MFS) who have progressed on one or two lines of chemotherapy.
Detailed 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 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).
Trial Arms
Name | Type | Description | Interventions |
---|
Envafolimab | Experimental | Patients treated with 300 mg of single agent envafolimab every three weeks | |
Envafolimab + Ipilimumab | Experimental | 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. | |
Eligibility Criteria
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
Maximum Eligible Age: | N/A |
Minimum Eligible Age: | 12 Years |
Eligible Gender: | All |
Healthy Volunteers: | No |
Primary Outcome Measures
Measure: | Objective response rate (ORR) by RECIST 1.1 assessed by blinded independent central review |
Time Frame: | 22 months |
Safety Issue: | |
Description: | |
Secondary Outcome Measures
Measure: | Duration of response (DR) assessed by blinded independent central review |
Time Frame: | 22 months |
Safety Issue: | |
Description: | |
Measure: | Disease control rate (DCR) assessed by blinded independent central review |
Time Frame: | 22 months |
Safety Issue: | |
Description: | |
Measure: | Progression free survival (PFS) assessed by blinded independent central review |
Time Frame: | 22 months |
Safety Issue: | |
Description: | |
Measure: | Overall survival (OS) |
Time Frame: | 22 months |
Safety Issue: | |
Description: | |
Measure: | Characterize envafolimab pharmacokinetics (PK) in patients receiving envafolimab as a single agent and in combination with ipilimumab |
Time Frame: | 22 months |
Safety Issue: | |
Description: | |
Measure: | Characterize ipilimumab PK in patients given ipilimumab with envafolimab |
Time Frame: | 22 months |
Safety Issue: | |
Description: | |
Measure: | Objective response rate (ORR) by investigator assessment |
Time Frame: | 22 months |
Safety Issue: | |
Description: | |
Measure: | Progression free survival (PFS) by investigator assessment |
Time Frame: | 22 months |
Safety Issue: | |
Description: | |
Measure: | Characterize the immunogenicity of envafolimab and ipilimumab |
Time Frame: | 22 months |
Safety Issue: | |
Description: | |
Details
Phase: | Phase 2 |
Primary Purpose: | Interventional |
Overall Status: | Recruiting |
Lead Sponsor: | Tracon Pharmaceuticals Inc. |
Trial Keywords
Last Updated
June 3, 2021