A Phase II Study of Palbociclib and INCMGA00012 in People with Advanced Dedifferentiated Liposarcoma

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Full Title

A Phase II Study of CDK4/6 Inhibition (Palbociclib) Combined with PD-1 Blockade (INCMGA00012) in Patients with Advanced Well-differentiated and/or Dedifferentiated Liposarcoma

Purpose

In this study, researchers are assessing the safety and effectiveness of combining the anticancer drug palbociclib with the investigational drug INCMGA00012 in people with metastatic or inoperable liposarcoma. Palbociclib works by blocking a protein (called CDK4) that is commonly found in liposarcoma cells and contributes to cancer cell growth. INCMGA00012 is an immunotherapy drug that boosts the body’s natural defenses to fight cancer.

Palbociclib is already used to treat certain types of breast cancer; its use in this study is considered investigational. It is taken orally (by mouth). INCMGA00012 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 metastatic or inoperable dedifferentiated liposarcoma.
  • Patients should recover from the serious side effects of previous therapies before receiving the study treatment.
  • Patients may not have previously received treatment with a CDK4 inhibitor or an immunotherapy drug.
  • 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

20-062

Phase

II

Investigator

Co-Investigators