A Study of Envafolimab Alone and in Combination with Ipilimumab Immunotherapy in People with Undifferentiated Pleomorphic Sarcoma or Myxofibrosarcoma

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Full Title

KN035SAR201: 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 in Prior Chemotherapy

Purpose

The purpose of this study is to assess the safety and effectiveness of the immunotherapy envafolimab given alone or in combination with ipilimumab immunotherapy in patients with inoperable or metastatic undifferentiated pleomorphic sarcoma (UPS) or myxofibrosarcoma (MFS). Both drugs boost the power of the immune system by enhancing its ability to detect and destroy cancer cells. Envafolimab does this by blocking a protein called PD-L1 and ipilimumab works by blocking CTLA-4. Both of these proteins are used by cancer cells to avoid being “seen” by the immune system. 

Patients will be randomly assigned to receive either envafolimab alone or envafolimab plus ipilimumab. Envafolimab is given as an injection under the skin and ipilimumab is given intravenously (by vein).

Eligibility

To be eligible for this study, patients must meet several criteria, including but not limited to the following:

  • Patients must have inoperable or metastatic UPS or MFS that continues to grow despite at least one but no more than two prior regimens of chemotherapy.
  • Prior immunotherapy is not permitted.
  • Patients must be physically well enough that they are fully ambulatory, capable of all self-care, and capable of all but physically strenuous activities. As an example, patients must be well enough that they would be able to carry out office work or light housework.
  • This study is for patients age 12 and older.

For more information about this study and to inquire about eligibility, please contact Dr. Sandra P. D’Angelo at 646-888-4159.

Protocol

21-065

Phase

II

Disease Status

Relapsed or Refractory

Investigator

Co-Investigators