Study on Botensilimab and Balstilimab for Rectal Cancer

Inclusion Criteria

• Must be willing and able to provide written consent to participate in the study. If unable, a legal representative can consent on their behalf.
• Must be 18 years or older.
• Must have a performance status that indicates they are fully active or have some restrictions but can still carry out light work.
• Must have a confirmed diagnosis of rectal adenocarcinoma.
• The cancer must be located within 15 cm from the anal verge and staged as specific types using imaging tests.
• No evidence of cancer spread to distant parts of the body.
• Must have measurable or evaluable disease.
• Tumor must show specific genetic stability or enzyme presence.
• Women of childbearing potential must have a negative pregnancy test and agree to use effective birth control during the study and for 150 days after the last dose.
• Must have adequate organ function as shown by specific blood tests within 14 days before starting treatment.

Exclusion Criteria

• Have recurrent rectal cancer.
• Have had previous radiation, chemotherapy, or surgery for rectal cancer.
• Have a tumor causing bowel blockage, unless a temporary ostomy is in place.
• Have had another invasive cancer within the last 2 years, except for certain skin or cervical cancers.
• Have an active infection needing treatment.
• Are receiving other cancer treatments or experimental therapies.
• Have a known history of HIV.
• Have active hepatitis B or C.
• Have received a live vaccine within 28 days before starting the study treatment.
• Have received a COVID-19 vaccine or booster less than 7 days before starting treatment.
• Have significant heart disease or recent heart attack or stroke.
• Have active tuberculosis.
• Are taking systemic steroids or other immunosuppressive drugs, except for certain conditions like allergies or hormone replacement.
• Have a significant autoimmune disease needing treatment in the last 5 years, except for certain conditions like vitiligo or controlled endocrine disorders.
• Have had a tissue or organ transplant, except for corneal transplants.