Study on Envafolimab and Envafolimab with Ipilimumab for Patients with Advanced Undifferentiated Pleomorphic Sarcoma or Myxofibrosarcoma

Sponsor: Tracon Pharmaceuticals Inc.

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT04480502

Provider View

This clinical trial is testing two treatments, envafolimab alone and envafolimab combined with ipilimumab, for patients with advanced or spreading undifferentiated pleomorphic sarcoma or myxofibrosarcoma who have not responded to previous chemotherapy.

Patient Parameters

Program Overview

The study aims to evaluate the effectiveness of two treatment options for patients with advanced undifferentiated pleomorphic sarcoma (UPS) or myxofibrosarcoma (MFS) that cannot be surgically removed or has spread. Patients will receive either envafolimab alone or in combination with ipilimumab. The trial is open to those who have already tried one or two chemotherapy treatments without success.

Description

This clinical trial involves testing two different treatment approaches for patients with advanced undifferentiated pleomorphic sarcoma (UPS) or myxofibrosarcoma (MFS) that cannot be surgically removed or has spread. Participants will be randomly assigned to receive either envafolimab alone or envafolimab combined with ipilimumab. Envafolimab is given as an injection under the skin every three weeks, while ipilimumab is given through an IV every three weeks for four doses. The study aims to determine which treatment is more effective in controlling the cancer. Patients who have already tried one or two chemotherapy treatments without success are eligible to participate. The study will monitor the safety and effectiveness of these treatments in managing the disease.

Eligibility Criteria

Inclusion Criteria

  • Have a confirmed diagnosis of advanced or spreading undifferentiated pleomorphic sarcoma (UPS) or grade 2 or higher myxofibrosarcoma (MFS).
  • The cancer must have worsened after previous chemotherapy.
  • Have at least one tumor that can be measured by scans.
  • Be in good overall health with a performance status of 0 or 1, meaning fully active or restricted in physically strenuous activity but ambulatory.
  • Have adequate blood and organ function as determined by specific tests.

Exclusion Criteria

  • Have received more than two previous chemotherapy treatments for UPS/MFS.
  • Have previously been treated with immune checkpoint inhibitors or immunomodulatory therapy.
  • Have an active autoimmune disease requiring treatment.
  • Have had major surgery within four weeks before starting the study treatment.
  • Have another active cancer.
  • Have fluid buildup around the heart, lungs, or abdomen.
  • Have cancer that has spread to the brain or spinal cord.
  • Have active hepatitis or liver cirrhosis.
  • Have interstitial lung disease.
  • Are unwilling to use effective birth control during the study.
  • Have other severe or uncontrolled medical conditions that could interfere with participation in the study.

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