A Phase I/II Study of REGN5668 plus Cemiplimab or REGN4018 in People with Recurrent Ovarian Cancer

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Full Title

Phase 1/2 Study of REGN5668 (MUC16 X CD28, A Costimulatory Bispecific) Administered in Combination with Cemiplimab or REGN4018 (MUC16 X CD3)

Purpose

Researchers are doing this study to find out whether giving the investigational drug REGN5668 with cemiplimab immunotherapy or with REGN4018 is a safe treatment for people with ovarian, peritoneal, or fallopian tube cancer. They will also try to find the highest dose of REGN5668 that can be given safely with cemiplimab or with REGN4018.

REGN5668 and REGN4018 are both drugs called “bispecific antibodies.” A bispecific antibody is made to attach to two specific proteins involved in the growth and survival of cancer cells. REGN5668 and REGN4018 may help activate T cells, which are immune cells that help the body fight infections and may also kill cancer cells.

Cemiplimab works by blocking a protein called PD-1 that normally acts as a brake on the immune system. Blocking this protein is like releasing the brake, enabling the immune system to target cancer cells and destroy them. All of the medications used 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 advanced ovarian, fallopian tube, or primary peritoneal cancer that continues to grow despite treatment.
  • Participants should recover from the serious side effects of previous therapies before they receive the study treatment.
  • Patients must be physically well enough that they are able to be mobile, take care of themselves, and engage in all but physically strenuous activities. For example, they must be well enough that they could carry out office work or light housework.
  • This study is for women age 18 and older.

For more information about this study and to ask about eligibility, please call the office of Dr. Roisin O’Cearbhaill at 646-888-4227.

Protocol

21-229

Phase

I/II

Investigator

Co-Investigators