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

Overview

About this study

The purpose of this study is determine objective response rate (ORR) by RECIST 1.1 by blinded independent central review (BICR) of envafolimab (cohort A), and of envafolimab combined with ipilimumab at 1 mg/kg (cohort B), in separate cohorts of patients with locally advanced, unresectable or metastatic UPS/MFS that has progressed following one or two lines of chemotherapy, without a formal statistical comparison between the two cohorts.

 

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

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.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Jacksonville, Fla.

Mayo Clinic principal investigator

Steven Attia, D.O.

Closed for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

Rochester, Minn.

Mayo Clinic principal investigator

Steven Robinson, M.B.B.S.

Closed for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

More information

Publications

Publications are currently not available

Additional contact information

Cancer-related trials contact form

Phone: 855-776-0015 (toll-free)

International patient clinical studies questions