Phase 2 Colorectal Cancer Trial, Recruiting

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• The person joining (or their legal representative) must be willing and able to give written consent to participate.
• A diagnosis of colorectal cancer must have been confirmed through laboratory testing of tissue samples.
• People aged 18 or older at the time of signing the consent form.
• Consent to allow stored tissue samples and blood draws to be used for research purposes.
• A general health and activity level rated as fully active or able to carry out light work (ECOG 0 or 1), as assessed by a doctor.
• Test results showing that the cancer is of a specific type called non-MSI-H/pMMR, confirmed by laboratory testing (confirm with trial site for details on how this is assessed).
• Consent to undergo a specific genetic tumour test (MSK IMPACT or similar next-generation sequencing), if not already done.
• For Cohorts 1a and 2a: Complete surgical removal of stage III colon or rectal cancer, followed by a standard chemotherapy course (FOLFOX or CAPEOX), with some flexibility depending on prior treatment history.
• For Cohorts 1b and 2b: Complete surgical removal of cancer that has spread to the liver, plus completion of standard chemotherapy around the time of surgery, with some flexibility depending on prior treatment history.
• A blood test called ctDNA must show a positive result after completing standard treatment, and consent must be provided within 6 weeks of that result being reported.
• Blood counts, kidney function, and liver function must meet minimum levels as measured by standard blood tests (confirm specific values with trial site).
• People of childbearing potential (or with a partner of childbearing potential) must agree to use effective contraception from the screening visit through at least 5 months after the last dose of study treatment.

Who may not be able to join:

• People whose cancer has spread to other parts of the body or has come back.
• People with a specific genetic mutation in the POLE or POLD genes in their cancer.
• People whose surgery did not remove all of the cancer (where some cancer was left behind at the edges of the removed tissue).
• People currently taking part in another clinical trial or who have received an experimental treatment within the past 4 weeks.
• People with an immune system condition, or who are taking steroid or immunosuppressive medications within 7 days before the first dose (with some specific exceptions, such as inhaled steroids or low-dose steroids used briefly — confirm with trial site).
• People with a known allergy or sensitivity to the study drugs (botensilimab or balstilimab) or their ingredients.
• People who have received chemotherapy, targeted therapy, or radiation within 2 weeks before the study start date, or who have not recovered from side effects of previous treatment.
• People with a history of, or current signs of, a non-infectious lung condition called pneumonitis.
• People with an active infection that requires treatment with antibiotics or other systemic medicines.
• People with any condition, treatment, or test result that a doctor believes could interfere with the trial or would not be in the person's best interest.
• People with known psychiatric conditions or substance use disorders that would make it difficult to take part in the trial.
• People who are pregnant, breastfeeding, or planning to conceive a child during the trial period and up to 90 days after the last dose.
• People who have previously been treated with certain types of immunotherapy drugs (anti-PD-1, anti-PD-L1, or anti-CTLA-4 agents).
• People with an active autoimmune disease, or a history of autoimmune disease that needed ongoing systemic treatment within the past 2 years (with some exceptions such as vitiligo, stable thyroid conditions on hormone replacement, or mild psoriasis not needing systemic treatment).
• People with active tuberculosis (TB).
• People with uncontrolled HIV infection (people on stable HIV treatment with undetectable virus and normal immune counts for at least 6 months may be considered eligible — confirm with trial site).
• People with evidence of active hepatitis B infection (people who have received treatment and have undetectable levels of the virus may be considered eligible — confirm with trial site).
• People with active hepatitis C infection confirmed by testing (people who have completed antiviral treatment and have been virus-free for at least 6 months may be considered eligible — confirm with trial site).
• People who have received a live vaccine within 30 days before the planned start of the study.

Important: Always verify eligibility with the trial site directly before applying.