Study on Botensilimab and Balstilimab for Treating Colorectal Cancer

Inclusion Criteria

• Have a confirmed diagnosis of colorectal cancer that cannot be surgically removed and has spread.
• The cancer must have been tested for specific genetic markers (MSI-H or dMMR).
• Agree to participate by signing a consent form.
• Have tried at least one chemotherapy treatment for cancer that has spread or returned, including specific drugs if available.
• Cancer must have grown during or shortly after the last treatment.
• Have measurable cancer on scans.
• Expected to live at least 12 more weeks.
• Be in good overall health with a performance status of 0 or 1.
• Have good organ function.
• Women who can have children must test negative for pregnancy before starting the study.
• Men with partners who can have children must agree to use effective birth control during the study and for a period after.
• No recent use of certain supportive treatments like blood transfusions within 14 days before starting the study.

Exclusion Criteria

• Cancer has specific genetic markers (MSI-H/dMMR).
• Have received certain immune therapies before.
• Have taken regorafenib or trifluridine/tipiracil before.
• Have had a bowel obstruction recently or signs of one.
• Have fluid buildup in the abdomen that is hard to treat.
• Have untreated liver metastases unless treated over 6 months ago with no signs of cancer in the liver.
• Have serious heart disease.
• Have active brain cancer or cancer in the brain lining.
• Have another cancer needing treatment or a history of active cancer in the last 2 years, except for certain skin or prostate cancers.
• Have taken certain cancer drugs recently.
• Have allergies to study drugs.
• Have lung disease or history of lung inflammation needing steroids.
• Have had organ or stem cell transplants.
• Have mental health or substance abuse issues affecting study participation.
• Need high doses of steroids or immunosuppressive drugs.
• Have active autoimmune disease needing treatment in the last 2 years.
• Have conditions or infections that could affect study results or participation.
• Have had COVID-19 recently.
• Have uncontrolled HIV or hepatitis infections.
• Have high protein levels in urine.
• Have high blood pressure not controlled by medication.
• Need certain medications affecting drug metabolism.
• Have digestive issues affecting drug absorption.
• Have non-healing wounds or active bleeding.