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.

Conditions

Eligibility

Eligible Ages
Over 12 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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

Study Design

Phase
Phase 2
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Envafolimab
Patients treated with 300 mg of single agent envafolimab every three weeks
  • Biological: Envafolimab
    PD-L1 single domain antibody for subcutaneous injection.
    Other names:
    • KN035
  • Drug: Ipilimumab
    CTLA-4 monoclonal antibody
    Other names:
    • Yervoy
Experimental
Envafolimab + Ipilimumab
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.
  • Biological: Envafolimab
    PD-L1 single domain antibody for subcutaneous injection.
    Other names:
    • KN035
  • Drug: Ipilimumab
    CTLA-4 monoclonal antibody
    Other names:
    • Yervoy

Recruiting Locations

Vanderbilt University
Nashville, Tennessee 37235

More Details

Status
Recruiting
Sponsor
Tracon Pharmaceuticals Inc.

Study Contact

Charles Theuer, MD, PhD
858-550-0780
clinicaltrials@traconpharma.com

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).

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.