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

Recruitment & Eligibility

Status: Not yet recruiting

Sex: All

Target Recruitment: 50

Inclusion 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 next generation sequencing (NGS) and immune-phenotyping. - Have one of the KRAS mutations included in the vaccine at the time of vaccination expressed in tumor. - Have received 4-6 months of FOLFIRINOX for the treatment of metastatic or unresectable PDAC or CRC. - Eastern Cooperative Oncology Group (ECOG) performance status 0. - Life expectancy of greater than 3 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. - 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. - History of malignant small bowel obstruction. - On parenteral nutrition. - Known or suspected hypersensitivity to Hiltonol.

Exclusion Criteria

Not provided

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Progression-free Survival (PFS);Objective Response Rate (ORR);Number of participants experiencing study drug-related toxicities

Secondary Outcome Measures

Name	Time	Method
Objective Response Rate (ORR) per RECIST 1.1;Disease Control Rate (DCR);Disease Control Rate (DCR);Disease Control Rate (DCR);Progression-free Survival (PFS) per RECIST 1.1

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