A Phase I/II Study of INCMGA00012 Immunotherapy with Gemcitabine and Docetaxel in People with Advanced Soft Tissue Sarcoma

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Full Title

Phase I/II Study of Gemcitabine and Docetaxel Combined with Immune Checkpoint Blockade (INCMGA00012) in Patients with Advanced Soft Tissue Sarcoma

Purpose

The purpose of this study is to assess the safety and effectiveness of giving the investigational immunotherapy drug INCMGA00012 in combination with gemcitabine and docetaxel in patients with inoperable or metastatic soft tissue sarcoma. Gemcitabine and docetaxel are standard treatments for this disease; researchers believe that adding INCMGA00012 may make treatment more effective.

INCMGA00012 works by boosting the power of the immune system to recognize and fight cancer. All of the medications in this study are 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 soft tissue sarcoma.
  • Patients may not have received chemotherapy for advanced disease. Prior systemic treatments are allowed if they were completed a year or more before entering the study.
  • 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 18 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

20-316

Phase

I/II

Disease Status

Newly Diagnosed

Investigator

Co-Investigators