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

Sponsor: Tracon Pharmaceuticals Inc.

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT04480502

Patient View

This multicenter study evaluates envafolimab alone or with ipilimumab in patients with advanced UPS/MFS post-chemotherapy. Eligible participants have confirmed UPS/MFS, disease progression, measurable lesions, ECOG status 0-1, and adequate organ function. Envafolimab is a PD-L1 antibody; ipilimumab targets CTLA-4. Cohort D enrollment is terminated.

Patient Parameters

Program Overview

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.

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). Following amendment #4, enrollment into cohort D was terminated and no further interim analyses will be conducted on this cohort.

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

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