Clinical Trial Finder

Comments

For patients with metastatic MSS CRC who have progressed on 2 or more lines of chemotherapy, with KRAS mutation expression.
Three immunotherapies:
– Pooled mutant-KRAS peptide vaccine (KRAS peptide vaccine) with poly-ICLC adjuvant (targeted immunotherapy, therapeutic vaccine)
– nivolumab (anti PD-1, Opdivo)
– ipilimumab (anti CTLA-4, Yervoy)

4 weeks wash-out from other therapies required, no prior immunotherapy allowed.
Measurable disease, lesion for biopsy required.

Contacts

Inclusion Criteria

Inclusion Criteria:

PDAC or metastatic MSS CRC Cohort:

* 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 exposure to 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. * 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. Reinduction Treatment Cohort: * Have a single site of locoregional recurrence or distant metastasis noted on imaging > 12 months after the first dose of the mutant KRAS peptide vaccine with poly-ICLC adjuvant.
* Have completed definitive treatment for solitary recurrence per standard-of-care (e.g. surgical resection, radiation, and/or chemotherapy) 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 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.
* PDAC or metastatic MSS CRC Cohort: 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 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 and Reinduction Treatment Cohorts, any peritoneal involvement by the tumor. * For metastatic MSS CRC and Reinduction Treatment Cohorts, any radiological or clinical pleural effusions or ascites. * For metastatic MSS CRC and Reinduction Treatment Cohorts, patients on parenteral nutrition. * For metastatic MSS CRC and Reinduction Treatment Cohorts, patients with any single liver metastases greater than 5 cm or greater > 50% liver involvement.
* For metastatic MSS CRC and Reinduction Treatment Cohorts, history of malignant bowel obstruction.