Open Actively Recruiting

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

About

Brief Summary

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.

Primary Purpose
Treatment
Study Type
Interventional
Phase
Phase II

Eligibility

Gender
All
Healthy Volunteers
No
Minimum Age
12 Years
Maximum Age
N/A

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

Join this Trial

Contact our clinical trial navigators for opportunities that may be suitable for you
Study Stats
Protocol No.
20-001550
Category
Hematology-Oncology
Oncology
Contact
Shenetra Walker
Location
  • UCLA Santa Monica
  • UCLA Westwood
For Providers
NCT No.
NCT04480502
For detailed technical eligibility, visit ClinicalTrials.gov.