KRAS-Targeted Vaccine Combined With Balstilimab and Botensilimab for Patients With Stage IV MMR-p Colorectal Cancer and Pancreatic Ductal Cancer

Exclusion Criteria

• •Is a candidate for definitive surgical resection.
• •Known history or evidence of brain metastases and/or leptomeningeal spread.
• •Prior treatment with immunotherapy agents (including, anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA4, etc.).
• •Receiving active immunosuppressive agents or chronic use of systemic corticosteroids within 14 days of vaccine treatment.
• •Has active autoimmune disease that has required systemic treatment in the past 5 years, or a documented history of clinically severe autoimmune disease, or a syndrome that requires systemic steroids or immunosuppressive agents.
• •Known history or concurrent interstitial lung disease.
• •Has a pulse oximetry \< 95% on room air.
• •Requires the use of home oxygen.
• •Infection with HIV or hepatitis B or C.
• •Uncontrolled intercurrent illness including, but not limited to, uncontrolled infection, symptomatic congestive heart failure, unstable angina, cardiac arrhythmia, metastatic cancer, or psychiatric illness/social situations that would limit compliance with study requirements.
• •Has been diagnosed with another cancer or myeloproliferative disorder in the past 5 years except for superficial bladder cancer, non-melanoma skin cancers, DCIS, a low-grade prostate cancer, or a cancer not expected to impact life expectancy and not requiring therapy.
• •Has had surgery within 28 days of dosing of investigational agent, excluding minor procedures (dental work, skin biopsy, etc.), celiac plexus block, and biliary stent placement.
• •Has received any non-oncology live vaccine therapy used for prevention of infectious diseases within 28 days of study treatment.
• •If at the time of signing informed consent, a regular user (including "recreational use") of any illicit drugs or other substance abuse (including alcohol) that could potentially interfere with adherence to study procedures or requirements.
• •Any other sound medical, psychiatric, and/or social reason as determined by the Investigator.
• •Unwilling or unable to follow the study schedule for any reason.
• •Are pregnant or breastfeeding.
• •Any radiological or clinical pleural effusions or ascites.
• •History of malignant small bowel obstruction.
• •On parenteral nutrition.
• •Known or suspected hypersensitivity to Hiltonol.