A Phase 2 Study of Botensilimab and Balstilimab Immunotherapy for Colorectal Cancer

In the U.S.

Full Title

Phase II Study of Adjuvant Botensilimab in Combination with Balstilimab in Patients with Colorectal Cancer and Persistent Circulating Tumor DNA Following Surgery and Chemotherapy

Purpose

Researchers want to see how well botensilimab and balstilimab immunotherapy works in people who were treated for colorectal cancer. The people in this study were diagnosed with either colon cancer or colorectal liver metastases (cancer that spread to the liver).

Their cancer was microsatellite stable (MSS), which means that their cells were working normally to repair mistakes during cell division. They now have circulating tumor DNA (ctDNA). This means there are fragments of DNA shed by cancer cells in the bloodstream. Having measurable ctDNA means the cancer may have a greater chance of coming back.

Botensilimab and balstilimab work in different ways to take the brakes off the immune response. They boost the power of the immune system to find and destroy cancer cells. The researchers want to see if giving this immunotherapy after patients finished their main treatment lowers the chance of their cancer coming back.

If you take part in this study, you will get botensilimab and balstilimab followed by balstilimab alone. Both drugs are given intravenously (by vein).

Who Can Join

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

Have been diagnosed with stage 3 MSS colon cancer or colorectal liver metastases.
Have measurable levels of ctDNA.
Have had surgery and chemotherapy in the past 6 months. Within 6 months after surgery and chemotherapy, you must have had a scan that showed no signs of cancer.
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.