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

STATUS

Recruiting
End date

Jun 1, 2024
participants needed

30
sponsor

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

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Updated on 4 October 2022

See if I qualify

measurable disease

KRAS

oxaliplatin

irinotecan

nivolumab

ipilimumab

cancer chemotherapy

adjuvant chemotherapy

immunostimulant

pdac

ki-ras

Summary

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.

Details

Condition	Colorectal Cancer, Pancreatic Cancer
Treatment	Ipilimumab, Nivolumab, KRAS peptide vaccine
Clinical Study Identifier	NCT04117087
Sponsor	Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Last Modified on	4 October 2022

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