Personalized Neoantigen Peptide-Based Vaccine in Combination With Pembrolizumab for Treatment of Advanced Solid Tumors
Eligible age
16+ yrs
Accepts
All genders
Locations
1 state
Healthy volunteers
No
See if you qualify for this study
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About this study
This phase I/II trial tests the safety and tolerability of an experimental personalized vaccine when given by itself and with pembrolizumab in treating patients with solid tumor cancers that have spread to other places in the body (advanced). The experimental vaccine is designed target certain proteins (neoantigens) on individuals' tumor cells. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving the personalized neoantigen peptide-based vaccine with pembrolizumab may be safe and effective in treating patients with advanced solid tumors.
Sponsor: Mayo Clinic
You may qualify if…
- ✓ PHASE I PRE-REGISTRATION, ALL:
- ✓ Willing to provide tissue specimens per protocol, or have clinically collected formalin-fixed paraffin-embedded (FFPE) tissue blocks, or available sequencing data available from commercial or research tests
- ✓ NOTE 1: Includes fresh tissue specimen at pre-registration, or with or clinically collected FFPE tissue blocks for complete exome and transcriptome sequencing. Patients who had tumor sequencing under certain Mayo IRB protocols and neoantigen has been identified or REAL Neo vaccine produced are allowed to proceed to pre-registration and/or registration.
- ✓ NOTE 2: This criteria will not apply to patients who had sequencing and neoantigen prediction previously completed.
- ✓ Measurable disease as defined by RECIST (v 1.1) criteria or non-measurable disease
- ✓ NOTE: Tumor lesions in previously irradiated area are not considered measurable disease
- ✓ Patients with actionable genomic abnormality including, but not limited to EGFR, ALK, MET, ROS-1, RET, NTRK, KRAS or BRAF must have received and progressed on at least one line of prior FDA-approved targeted therapy
- ✓ Provide written informed consent. For pediatric patients (age 16-17 years):
You may not qualify if…
- ✕ ALL PHASES:
- ✕ Any of the following because study involves investigational agent whose genotoxic, mutagenic and teratogenic effects on developing fetus and newborn are unknown:
- ✕ Pregnant person
- ✕ Nursing person unwilling to stop breast feeding
- ✕ Person of childbearing potential unwilling to employ adequate contraception from registration through 6 months after final vaccine cycle
- ✕ Co-morbid systemic illnesses or other severe concurrent disease which, in judgment of investigator, would make patient inappropriate for entry into this study or interfere significantly with proper assessment of safety and toxicity of prescribed regimens
- ✕ History of myocardial infarction ≤ 6 months prior to pre-registration, or congestive heart failure requiring use of ongoing maintenance therapy for life-threatening ventricular arrhythmias.
- ✕ Immunocompromised patients and patients known to be human immunodeficiency virus (HIV) positive and currently receiving antiretroviral therapy
Where it's recruiting
Jacksonville
Source: ClinicalTrials.gov · NCT05269381 · last updated 2026-08-20