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

• Status: Recruiting
• Trial end date: 2022-07-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Tracon Pharmaceuticals Inc.
• Treatments: Ipilimumab

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