A Phase 2 Study of Botensilimab and Balstilimab Immunotherapy Before Surgery for Rectal Cancer

In the U.S.

Full Title

A Phase II Study of Neoadjuvant Botensilimab and Balstilimab Immunotherapy for Mismatch Repair Proficient Rectal Adenocarcinoma

Purpose

Researchers are assessing botensilimab and balstilimab given as initial treatment for rectal cancer. The people in this study have rectal cancer that has not spread beyond nearby lymph nodes (locally advanced).

Their tumors are also mismatch repair proficient (MMRp)/microsatellite stable (MSS). MMRp/MMS means that their cells are working normally to repair any mistakes made during cell division.

Botensilimab and balstilimab inhibit proteins that cancer cells use to avoid being detected by the immune system. Blocking these proteins is like releasing the brakes on the immune system, enabling it to target and destroy cancer cells. Both drugs are given intravenously (by vein).

If you join this study, you will get both botensilimab and balstilimab. You will then also receive a standard combination of chemotherapy drugs (either CAPEOX or FOLFOX). Depending on how your cancer responds, you may then have standard chemoradiation and surgery to remove your tumor.

Who Can Join

To join this study, there are a few conditions. You must:

Have locally advanced MMRp/MMS rectal cancer that has not yet been treated.
Be well enough to walk and take care of yourself. You must be able to do activities such as office work or light housework.
Be age 18 or older.