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

Full Title

A Phase 1/2 Study of REGN5668 (MUC16xCD28, a Costimulatory Bispecific Antibody) Administered in Combination with Other Agents in MUC16+ Malignancies

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).

Protocol
21-229
Phase
Phase I/II (phases 1 and 2 combined)
Investigator
Co-Investigators
ClinicalTrials.gov ID
NCT04590326