Clinical Trials /

Envafolimab And Envafolimab With Ipilimumab In Patients With Undifferentiated Pleomorphic Sarcoma Or Myxofibrosarcoma

NCT04480502

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.

Related Conditions:
  • Myxofibrosarcoma
  • Undifferentiated Pleomorphic Sarcoma
Recruiting Status:

Not yet recruiting

Phase:

Phase 2

Trial Eligibility

Document

Title

  • Brief Title: Envafolimab And Envafolimab With Ipilimumab In Patients With Undifferentiated Pleomorphic Sarcoma Or Myxofibrosarcoma
  • Official Title: 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

DrugSynonymsArms
EnvafolimabKN035Envafolimab
IpilimumabYervoyEnvafolimab + 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

NameTypeDescriptionInterventions
EnvafolimabExperimentalPatients treated with 300 mg of single agent envafolimab every three weeks
  • Envafolimab
Envafolimab + IpilimumabExperimentalPatients 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.
  • Envafolimab
  • Ipilimumab

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:Not yet recruiting
Lead Sponsor:Tracon Pharmaceuticals Inc.

Trial Keywords

  • sarcoma

Last Updated

July 16, 2020