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Cancer Vaccine
Cancer Vaccine + Pembrolizumab for Advanced Cancers (PNeoVCA Trial)
Phase 1
Recruiting
Led By Yanyan Lou
Research Sponsored by Mayo Clinic
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
PRE-REGISTRATION COHORT 1 ONLY: Has cancer progression after at least one line of standard of care systemic treatment
PRE-REGISTRATION: Eastern Cooperative Oncology Group (ECOG) of 0 or 1
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years from first vaccine administration
Awards & highlights
PNeoVCA Trial Summary
This trial is testing a new, personalized cancer vaccine given with another immunotherapy drug. The goal is to see if it's safe and effective in treating patients with advanced solid tumors.
Who is the study for?
Adults with advanced solid tumors that have spread and are not treatable by surgery. Participants must have a life expectancy over 6 months, adequate organ function, and agree to use effective contraception. They should be willing to provide tissue samples for research and not have other active cancers or severe diseases.Check my eligibility
What is being tested?
The trial is testing the safety of a new personalized cancer vaccine combined with Pembrolizumab (an existing immunotherapy drug) in patients with various types of advanced solid tumors. The vaccine targets specific proteins on tumor cells to help the immune system fight cancer.See study design
What are the potential side effects?
Possible side effects include reactions at the injection site, flu-like symptoms from the vaccine, and typical immunotherapy-related issues like fatigue, skin rash, diarrhea, liver inflammation from Pembrolizumab.
PNeoVCA Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My cancer has worsened after receiving standard treatment.
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I am fully active or restricted in physically strenuous activity but can do light work.
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My cancer is advanced and cannot be removed by surgery.
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My kidneys work well enough, with a creatinine clearance of 50 ml/min or more.
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My kidney function, measured by creatinine levels or clearance, is within the required range.
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I have a specific gene change in my cancer and it has worsened after treatment with an FDA-approved targeted therapy.
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I am 18 years old or older.
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I am 18 years old or older.
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I am fully active or restricted in physically strenuous activity but can do light work.
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I have a specific gene change in my cancer and it has worsened despite treatment.
PNeoVCA Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 2 years from first vaccine administration
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 years from first vaccine administration
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Incidence of adverse events
Secondary outcome measures
Immunogenicity responders
The number and percentage of participants who completed the sequencing with satisfactory data quality registration and identified at least 10 actionable peptides, meet the eligibility criteria for registration, and able to initiate vaccine production
Other outcome measures
Immunity persistency
Objective response rate (ORR)
Pre-existing Immunity
PNeoVCA Trial Design
1Treatment groups
Experimental Treatment
Group I: Treatment (cyclophosphamide, vaccine, pembrolizumab)Experimental Treatment4 Interventions
Patients receive cyclophosphamide IV on day -3. Patients then receive personalized neoantigen vaccine with sargramostim SC on days 1, 4, 8, and 15 of cycle 1 and day 1 of cycles thereafter. Patients also receive pembrolizumab IV over 30 minutes on day 1. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Patients may undergo blood sample collection during screening, cycle 1 days -3, 1, 8, 15, 22, cycles 2, 3, 4, 5, 7, 8 and 9+ day 1 and 30 days after last dose of GM-CSF or pembrolizumab and may undergo tissue biopsy during screening, week 25 or at the time of disease progression. Patients also undergo CT or MRI during screening, week 9 then every 9 weeks, and 30 days after last dose of GM-CSF or pembrolizumab.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Sargramostim
FDA approved
Pembrolizumab
FDA approved
Cyclophosphamide
FDA approved
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)NIH
13,664 Previous Clinical Trials
40,925,970 Total Patients Enrolled
Mayo ClinicLead Sponsor
3,210 Previous Clinical Trials
3,767,121 Total Patients Enrolled
Yanyan LouPrincipal InvestigatorMayo Clinic
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My cancer has worsened after receiving standard treatment.I had a severe reaction to previous immunotherapy that needed steroids or stopped treatment.I am fully active or restricted in physically strenuous activity but can do light work.I have recovered from side effects of my previous cancer treatments.Your liver enzyme levels (AST and ALT) are not too high.I haven't taken steroids or immunosuppressants in the last 14 days.My cancer is advanced and cannot be removed by surgery.I have a neuromuscular disorder or a history of rhabdomyolysis.I have recovered from side effects of my previous cancer treatments.I have had chemotherapy, experimental drugs, radiation, major surgery, or a live vaccine within the last 30 days.I have an autoimmune disease treated within the last 30 days.Your hemoglobin level is at least 9.0 grams per deciliter.Your absolute neutrophil count is at least 1500 per cubic millimeter.My cancer has worsened after receiving at least one standard treatment.Your platelet count is 100,000 per cubic millimeter or higher.My kidneys work well enough, with a creatinine clearance of 50 ml/min or more.I do not have any severe illnesses that would prevent me from following the study's requirements.Women who can have children must have a recent negative pregnancy test before joining the study.Before joining the study, you need to have at least 100,000 platelets per cubic millimeter of blood.I do not have any severe illnesses besides my current condition.You have signs of leptomeningeal disease.Your absolute neutrophil count is 1500/mm^3 or higher.Your total bilirubin level is not higher than 1.5 times the upper limit of normal.I have brain metastases that are untreated, cause symptoms, or need steroids.I am immunocompromised or HIV positive and on antiretroviral therapy.Your liver enzymes (ALT and AST) are not more than 3 times the upper limit of normal (5 times the upper limit of normal if you have liver involvement).My cancer is advanced or has spread and cannot be removed by surgery.My cancer is advanced or has spread, and it's a type that can be treated with pembrolizumab.I am willing to get a tetanus shot if I haven't had one in the last year.I still have side effects from my last treatment that haven’t gone back to normal.I have had a heart attack in the last 6 months or have heart failure needing ongoing treatment.My cancer is advanced or has spread and cannot be surgically removed.I have a soft tissue lesion that can be biopsied.I have not had any other cancer within the last 3 years.I am not on any experimental drugs for my cancer, except pembrolizumab.My kidney function, measured by creatinine levels or clearance, is within the required range.My cancer is advanced or has spread, and it's a type that can be treated with pembrolizumab.I have a specific gene change in my cancer and it has worsened after treatment with an FDA-approved targeted therapy.I am nursing and not willing to stop breastfeeding.I have other serious illnesses besides my current condition.I am on long-term steroids or immunosuppressants for an autoimmune disease.Your hemoglobin level should be at least 9.0 grams per deciliter to participate in the study before signing up.Your total bilirubin levels should be less than or equal to 1.5 times the upper limit of normal.I am 18 years old or older.I am 18 years old or older.You have a disease that can be measured using specific criteria called RECIST (version 1.1).My cancer is advanced or has spread and cannot be removed by surgery.I have a soft tissue lesion that can be biopsied.My blood clotting tests are normal or I'm on blood thinners.My doctor agrees I can have pembrolizumab with or without chemotherapy.I am willing to get a tetanus shot if I haven't had one in the last year.My REAL-Neo vaccine has been successfully sequenced and produced.I am fully active or restricted in physically strenuous activity but can do light work.My doctor thinks Pembrolizumab alone is a good treatment option for me.I have a specific gene change in my cancer and it has worsened despite treatment.Your blood clotting tests should be within a certain range.You have a measurable disease based on specific medical criteria.My doctor thinks Pembrolizumab alone is a good treatment option for me.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (cyclophosphamide, vaccine, pembrolizumab)
Awards:
This trial has 3 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Approved for 20 Other Conditions - This treatment demonstrated efficacy for 20 other conditions.
- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Does this trial welcome new participants?
"According to the clinicaltrials.gov registry, this study is actively seeking subjects for enrollment. It was initially disclosed on March 31st 2022 and underwent its most recent update on April 8th 2022."
Answered by AI
Has the Neoantigen Peptide Vaccine been cleared for commercial use by the FDA?
"Due to the limited evidence for safety and efficacy, Neoantigen Peptide Vaccine was rated a 1 on our team's scale."
Answered by AI
How many participants are being included in this investigation?
"Affirmative, according to records hosted on clinicaltrials.gov this medical research is still open for recruitment of participants. The trial was posted on March 31st 2022 and most recently updated April 8th 2022; 36 people are needed from 1 centre."
Answered by AI
Who else is applying?
What state do they live in?
California
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
2
What site did they apply to?
Mayo Clinic in Florida
How responsive is this trial?
Typically responds via
Phone Call
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