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

  • STATUS
    Recruiting
  • End date
    Jul 17, 2022
  • participants needed
    160
  • sponsor
    Tracon Pharmaceuticals Inc.
Updated on 17 September 2021

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.

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).

Details
Condition Malignant Fibrous Histiocytoma, Myxofibrosarcoma
Treatment Ipilimumab, Envafolimab
Clinical Study IdentifierNCT04480502
SponsorTracon Pharmaceuticals Inc.
Last Modified on17 September 2021

Eligibility

Yes No Not Sure

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
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