Neoantigen-Targeted Vaccine Combined With Anti-PD-1 Antibody for Patients With Stage IV MMR-p Colon and Pancreatic Ductal Cancer

• Status: Not yet recruiting
• Trial end date: 2025-12-01
• Target enrollment: 0
• Participant gender: All

Summary

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).

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
• Collaborator: Incyte Corporation
• Treatments: Carboxymethylcellulose Sodium; Poly I-C; Poly ICLC

Criteria

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.