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ENVASARC: A Pivotal Trial Of Envafolimab, And Envafolimab In Combination With Ipilimumab, In Patients With Advanced Or Metastatic Undifferentiated Pleomorphic Sarcoma Or Myxofibrosarcoma Who Have Progressed On Prior Chemotherapy

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Trial Profile

ENVASARC: A Pivotal Trial Of Envafolimab, And Envafolimab In Combination With Ipilimumab, In Patients With Advanced Or Metastatic Undifferentiated Pleomorphic Sarcoma Or Myxofibrosarcoma Who Have Progressed On Prior Chemotherapy

Status: Discontinued
Phase of Trial: Phase II

Latest Information Update: 15 Jul 2024

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At a glance

  • Drugs Envafolimab (Primary) ; Ipilimumab (Primary)
  • Indications Malignant fibrous histiocytoma; Soft tissue sarcoma
  • Focus Registrational; Therapeutic Use
  • Acronyms ENVASARC
  • Sponsors TRACON Pharmaceuticals

    • Most Recent Events

    • 01 Jul 2024 According to TRACON Pharmaceuticals' media release, the company announced the termination of the ENVASARC trial. Hence, the status changed from active, no longer recruiting, to discontinued.
    • 01 Jul 2024 According to TRACON Pharmaceuticals media release, the company announced that the objective response rate (ORR) by blinded independent central review (BICR) in this fully enrolled trial was 5% (four responders) among 82 evaluable patients, which is below the 11% ORR needed to support a biologics license application (BLA). As a result, TRACON is discontinuing all clinical development of envafolimab.
    • 01 Jul 2024 Primary endpoint (Objective response rate (ORR) by RECIST 1.1 assessed by blinded independent central review) has not been met, According to TRACON Pharmaceuticals media release.

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