Phase 1 study for patients with resected PDAC after neoadjuvant and/ or adjuvant chemotherapy
and/or radiation, as well as patients with metastatic MSS CRC who have progressed on 2 or
more lines of chemotherapy, to evaluate safety and the immune response to pooled mutant-KRAS
peptide vaccine (KRAS peptide vaccine) with poly-ICLC adjuvant in combination with nivolumab
- Age ≥18 years.
- Have histologically or cytologically - proven cancer of the pancreas (PDA) or MSS
colorectal (CRC) in one of the following categories:
- PDAC must have no evidence of disease and last dose of neoadjuvant and/or
adjuvant chemotherapy/radiation therapy/or surgery must be < 6 months from study
- Metastatic MSS CRC after progression on 2 more lines of chemotherapy in the
metastatic setting including 5-flurouracil, irinotecan, and oxaliplatin exposure.
Patients treated with FOLFOXIRI may enroll after progression or intolerance to
- For metastatic MSS CRC cohort, must 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 Principal Investigator).
- For metastatic MSS CRC patients, must have measurable disease per RECIST 1.1.
- Have sufficient archival tumor tissue for next-generation sequencing (NGS) and
- Have one of the six KRAS mutations (KRASG12C, KRASG12V, KRASG12D, KRASG12A, KRASG13D
or KRASG12R) expressed in tumor.
- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
- 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.
- If expected to require any other form of systemic or localized antineoplastic therapy
while on study.
- Within 2 weeks prior to first dose of study drug.
- Any systemic or topical corticosteroids at immunosuppressive agents.
- Any palliative or adjuvant radiation or gamma knife radiosurgery.
- Any chemotherapy.
- Within 4 weeks prior to first dose of study drug.
- Any investigational cytotoxic drug.
- Any investigational device.
- Has received a live vaccine.
- Received any allergen hyposensitization therapy.
- Received any growth factors, e.g. granulocyte-colony stimulating factor (G-CSF),
granulocyte macrophage-colony stimulating factor (GM-CSF), erythropoietin.
- Any major surgery.
- Prior treatment with immunotherapy agents (including, anti-PD-1, anti-PD-L1,
anti-PD-L2, anti-cytotoxic T-lymphocyte-associated protein 4 (CTLA4), etc.).
- Hypersensitivity reaction to any monoclonal antibody.
- Known history or evidence of brain metastases.
- Has active autoimmune disease that has required systemic treatment in the past 2
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 < 92% 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
- Has a diagnosis of immunodeficiency.
- Presence of any tissue or organ allograft, regardless of need for immunosuppression,
including corneal allograft. Patients with a history of allogeneic hematopoietic stem
cell transplant will be excluded.
- Any other sound medical, psychiatric, and/or social reason as determined by the
- Unwilling or unable to follow the study schedule for any reason.
- Are pregnant or breastfeeding.
- For metastatic MSS CRC cohort, any peritoneal involvement by the tumor.
- For metastatic MSS CRC cohort, any radiological or clinical pleural effusions or
- For metastatic MSS CRC cohort, patients on parenteral nutrition.
- For metastatic CRC cohort, patients with any single liver metastases greater than 5 cm
or greater > 50% liver involvement.
- For metastatic MSS CRC cohort, history of malignant bowel obstruction.