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