A Phase I/II Study of REGN4018 Given Alone or in Combination with Cemiplimab in Women with Recurrent Ovarian Cancer

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Full Title

A Phase 1/2 Study of REGN4018 (A MUC16xCD3 Bispecific Antibody) Administered Alone or in Combination with Cemiplimab in Patients with Recurrent Ovarian Cancer

Purpose

The purpose of this study is to assess the safety of the investigational treatment REGN4018 alone and in combination with cemiplimab in women with ovarian, peritoneal, or fallopian tube cancer that has come back or gotten worse after previous treatment. REGN4018 is a type of drug called a bispecific antibody: it binds to two specific proteins (MUC16 and CD3) that may be involved in the growth and survival of cancer.

MUC16 is found on the cancer cells of most people who have ovarian, peritoneal, or fallopian tube cancer. CD3 is found on T cells, which are part of the immune system. Once REGN4018 finds cancer cells that have MUC16, it may help activate T cells against the cancer cells.

Cemiplimab is an immunotherapy, meaning it boosts the power of the immune system against cancer cells. It is used to treat cutaneous squamous cell carcinoma; its use in this study is considered investigational. The hope is that cemiplimab will help REGN4018 to kill cancer cells by activating the immune system. Both medications 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 ovarian, peritoneal, or fallopian tube cancer that has come back or gotten worse despite prior treatment.
  • Patients must recover from the serious side effects of previous treatment before receiving the study therapy.
  • 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 women age 18 and older.

For more information about this study and to inquire about eligibility, please contact Dr. Roisin O’Cearbhaill at 646-888-4227.

Protocol

20-190

Phase

I/II

Investigator

Co-Investigators