Actively Recruiting
A Phase I/II Study of Personalized Neoantigen Peptide-Based Vaccine with Pembrolizumab for Advanced Solid Tumors
Led by Mayo Clinic · Updated on 2026-03-12
132
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effectiveness of a personalized neoantigen peptide vaccine given alone or combined with pembrolizumab for patients with advanced solid tumors that have spread. This phase I/II trial aims to assess safety, event-free survival, disease-free survival, and immune responses in various cancers including triple-negative breast cancer and non-small cell lung cancer. The study also explores the vaccine's ability to stimulate immune responses and its persistence over time. Participants receive intravenous cyclophosphamide three days before starting vaccination. The personalized vaccine along with sargramostim is given subcutaneously on specific days during treatment cycles. Pembrolizumab is administered intravenously every 21 days in some cohorts, continuing up to two years unless disease progresses or unacceptable side effects occur. Patients may also undergo tumor biopsies, blood sample collections, and imaging scans like CT or MRI throughout the study. During the trial, participants are closely monitored with regular assessments including tumor imaging and blood tests. Follow-up visits occur 30 days after treatment and then every three months for up to two years. Researchers measure adverse events, immune responses, and survival outcomes to understand the vaccine’s safety and potential benefit. The total duration of participation varies but can last over two years including treatment and follow-up.
CONDITIONS
Brief Title
Personalized Neoantigen Peptide-Based Vaccine in Combination With Pembrolizumab for Treatment of Advanced Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Willing to provide tissue specimens and blood samples for research
- Measurable or non-measurable disease as defined by RECIST criteria
- Patients with actionable genomic abnormalities must have received and progressed on at least one prior FDA-approved targeted therapy
- Provide written informed consent
- Willing to return for follow-up visits
- Negative pregnancy test within 7 or 14 days prior to registration for persons of childbearing potential
- Willing to use effective contraception from pre-registration through 6 months after final vaccine cycle
- Willing to receive tetanus vaccination if not received within 1 year prior
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
- Anticipated life expectancy greater than 6 months
- Recovered from prior treatment toxicities to acceptable baseline status
- Laboratory values within specified limits including hemoglobin, neutrophils, platelets, bilirubin, liver enzymes, creatinine clearance, and coagulation parameters
- Successful sequencing and production of REAL-Neo vaccine
- Specific histological and staging criteria for triple-negative breast cancer and non-small cell lung cancer cohorts
- Evidence of residual disease or tumor size criteria for certain cohorts
- Patients must be willing to proceed with surgery if applicable
You will not qualify if you...
- Pregnant or nursing persons unwilling to stop breastfeeding
- Persons of childbearing potential unwilling to use adequate contraception from registration through 6 months after final vaccine cycle
- Co-morbid severe systemic illnesses or other diseases interfering with safety assessment
- Myocardial infarction within 6 months prior or congestive heart failure requiring maintenance therapy
- Immunocompromised patients including HIV positive on antiretroviral therapy
- Unrecovered acute effects of prior therapy
- Uncontrolled infections or illnesses including psychiatric or cardiovascular conditions
- Receiving other investigational agents except pembrolizumab
- Prior hypersensitivity or adverse reaction to GM-CSF
- Other active malignancy within 3 years except certain skin or cervical cancers
- Active autoimmune diseases requiring systemic treatment within 30 days prior
- Use of systemic corticosteroids or immunosuppressive medications above specified doses within 14 days prior
- Evidence of untreated or symptomatic central nervous system metastases
- Neuromuscular disorders or history of rhabdomyolysis
- Tissue or nucleic acid quality or quantity insufficient for sequencing
- Certain prior therapies within specified timeframes before registration
- CTCAE grade 3 or higher adverse events to prior checkpoint inhibitors or requiring systemic steroids
- Conditions limiting compliance with study requirements
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 2 years or until disease progression or unacceptable toxicity
Participants receive cyclophosphamide intravenously on day -3, followed by personalized neoantigen peptide vaccine with sargramostim subcutaneously on days 1, 4, 8, and 15 of the first cycle, and on day 1 of cycles 2, 5, and 8. Pembrolizumab is given intravenously on day 1 of each cycle or as clinically indicated. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Participants may undergo tumor biopsies, blood sample collections, and CT or MRI scans throughout treatment.
Multiple visits every 21 days for up to 2 years
Duration - Up to 2 years
After completion of study treatment, participants are followed up at 30 days and then every 3 months for up to 2 years from study enrollment to monitor safety and disease status.
Visits at 30 days post-treatment and every 3 months thereafter
Trial Site Locations
Total: 1 location
1
Mayo Clinic in Florida
Jacksonville, Florida, United States, 32224-9980
Actively Recruiting
Research Team
C
Clinical Trials Referral Office
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
4
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