Study on Temozolomide, Cisplatin, and Nivolumab for Colorectal Cancer

Inclusion Criteria

• Willing and able to provide written consent to participate.
• Diagnosed with colorectal adenocarcinoma confirmed by lab tests.
• Have advanced colorectal cancer that cannot be surgically removed or has spread.
• Tested for specific genetic markers and found to be mismatch repair-proficient (MSS or MMR proficient).
• Tested for BRAF and POLE genes and found to be wild type.
• Cancer has not responded to at least two standard chemotherapy treatments or has returned after treatment.
• Have at least one tumor that can be measured by scans.
• Be 18 years or older.
• Agree to provide tissue and blood samples for research.
• Have a performance status score of 0 or 1, indicating full activity or some restriction in strenuous activities.
• Have adequate organ function based on specific blood tests, including:
  • Neutrophil count of at least 1,500/mcL.
  • Platelet count of at least 100,000/mcL.
  • Creatinine levels within specified limits.
  • White blood cell count of at least 2000/μL.
  • Hemoglobin level of at least 9.0 g/dL.
  • Liver enzymes and bilirubin levels within specified limits.
  • Blood clotting times within specified limits unless on anticoagulant therapy.
• Use an effective method of contraception.

Exclusion Criteria

• Currently participating in another study or have used an investigational drug or device within 4 weeks before starting this trial.
• Have an immune deficiency or are taking high-dose steroids or other immune-suppressing drugs within 7 days before starting the trial.
• Have had chemotherapy or other cancer treatments within 2 weeks before starting the trial and have not recovered from side effects.
• Have had major surgery and not fully recovered.
• Have another active cancer that requires treatment, except for certain skin cancers or cervical cancer that has been treated.
• Have active cancer spread to the brain or spinal cord unless treated and stable.
• Have an active autoimmune disease requiring treatment within the past 3 months.
• Have an active infection needing treatment.
• Have any condition that might interfere with the trial or make participation unsafe.
• Have psychiatric or substance abuse issues that would interfere with the trial.
• Are pregnant, breastfeeding, or planning to conceive during the trial and for a specified time after.
• Have previously received certain immune therapies targeting T-cell pathways.
• Have a history of HIV or active hepatitis B or C infections.
• Have received a live vaccine within 30 days before starting the trial.
• Are a prisoner or involuntarily detained.