Pooled Mutant KRAS-Targeted Long Peptide Vaccine Combined With Nivolumab and Ipilimumab for Patients With Resected MMR-p Colorectal and Pancreatic Cancer

  • End date
    Jun 1, 2024
  • participants needed
  • sponsor
    Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Updated on 4 October 2022
measurable disease
cancer chemotherapy
adjuvant chemotherapy


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 and ipilimumab.

Condition Colorectal Cancer, Pancreatic Cancer
Treatment Ipilimumab, Nivolumab, KRAS peptide vaccine
Clinical Study IdentifierNCT04117087
SponsorSidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Last Modified on4 October 2022


Yes No Not Sure

Inclusion Criteria

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 entry
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 that regimen
Have sufficient archival tumor tissue for next-generation sequencing (NGS) and immune-phenotyping
For metastatic MSS CRC cohort, must have tumor lesions amenable to repeated biopsy
Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
For metastatic MSS CRC patients, must have measurable disease per RECIST 1.1
and patient's acceptance to have a tumor biopsy of an accessible lesion at
Life expectancy of greater than 6 months
baseline and on treatment if the lesion can be biopsied with acceptable
clinical risk (as judged by the Principal Investigator)
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
Have one of the KRAS mutations included in the vaccine at the time of vaccination expressed in tumor

Exclusion Criteria

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 palliative or adjuvant radiation or gamma knife radiosurgery
Any chemotherapy
Within 4 weeks prior to first dose of study drug
Any investigational cytotoxic drug
Systemic or topical steroids corticosteroids at immunosuppressive doses (> 10 mg/day of prednisone or equivalent). Inhaled or topical steroids, and adrenal replacement steroid doses ≤ 10 mg daily prednisone equivalent, are permitted in the absence of active autoimmune disease
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
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
Prior treatment with immunotherapy agents (including, anti-PD-1, anti-PD-L1
Has a pulse oximetry < 92% on room air
Requires the use of home oxygen
anti-PD-L2, anti-cytotoxic T-lymphocyte-associated protein 4 (CTLA4), etc.)
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 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 Investigator
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 ascites
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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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