Colon Cancer Clinical Trial
Neoantigen-Targeted Vaccine Combined With Anti-PD-1 Antibody for Patients With Stage IV MMR-p Colon and Pancreatic Ductal Cancer
Phase 1 study evaluating feasibility, safety, and immune response to a personalized neoantigen vaccine combined with retifanlimab for MMR-p mCRC and mPDAC patients with measurable disease following first-line FOLFIRINOX/FOLFOXIRI (FFX).
Age ≥18 years.
Have histologically or cytologically - proven cancer of the pancreas or colon.
Have tumor lesions amenable to repeated biopsy, and patient's acceptance to have a tumor biopsy of an accessible lesion at baseline and on treatment if the lesion can be biopsied with acceptable clinical risk (as judged by the investigator).
Measurable disease as per RECIST 1.1.
Have sufficient and accessible tissue for NGS and immune-phenotyping.
Have not received any prior systemic therapy in the metastatic setting for PDA or CRC. Patients who have received adjuvant chemotherapy >12 months prior to the diagnosis of metastatic disease may be eligible.
ECOG performance status 0.
Life expectancy of greater than 6 months.
Patients must have adequate organ and marrow function defined by study-specified laboratory tests prior to initial study drug.
Woman of childbearing potential must have a negative pregnancy test and follow contraceptive guidelines as defined per protocol.
Men must use acceptable form of birth control while on study.
Ability to understand and willingness to sign a written informed consent document.
Is a candidate for definitive surgical resection.
Is unwilling or unable to undergo standard of care therapy.
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 within the past 5 year.
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.
Any peritoneal involvement by the tumor.
History of malignant small bowel obstruction.
On parenteral nutrition.
Any liver metastasis greater than 3 cm or greater than 5 liver metastases.
Known or suspected hypersensitivity to Hiltonol.
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