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Cancer Vaccine

Cancer Vaccine + Pembrolizumab for Advanced Cancers (PNeoVCA Trial)

Phase 1 & 2

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

Must not have

REGISTRATION: CTCAE >= Grade 3 treatment-emergent adverse event (TEAE) to prior checkpoint inhibitor, TEAE requiring systemic corticosteroids, or permanent treatment discontinuation due to toxicity

PRE-REGISTRATION: Uncontrolled illness including, but not limited to ongoing or active infection, psychiatric illness/social situations, congestive heart failure with New York Heart Association class III or IV, moderate to severe objective evidence of cardiovascular disease, stroke =< 3 months prior to pre-registration, significant cardiac arrhythmia or unstable angina, any other conditions that would limit compliance with study requirements

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 2 years from first vaccine administration

Awards & highlights

No Placebo-Only Group

Approved for 20 Other Conditions

All Individual Drugs Already Approved

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.

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.

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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I had a severe reaction to previous immunotherapy that needed steroids or stopped treatment.

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I do not have any severe illnesses that would prevent me from following the study's requirements.

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I have a neuromuscular disorder or a history of rhabdomyolysis.

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I have had chemotherapy, experimental drugs, radiation, major surgery, or a live vaccine within the last 30 days.

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I have brain metastases that are untreated, cause symptoms, or need steroids.

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I am immunocompromised or HIV positive and on antiretroviral therapy.

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I still have side effects from my last treatment that haven’t gone back to normal.

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I have had a heart attack in the last 6 months or have heart failure needing ongoing treatment.

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I am not on any experimental drugs for my cancer, except pembrolizumab.

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I am nursing and not willing to stop breastfeeding.

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I am on long-term steroids or immunosuppressants for an autoimmune disease.

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 years from first vaccine administration for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Incidence of adverse events

Secondary study objectives

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 study objectives

Immunity persistency

Objective response rate (ORR)

Pre-existing Immunity

Awards & Highlights

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.

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

Cyclophosphamide

FDA approved

Pembrolizumab

FDA approved

Sargramostim

FDA approved

0 / 21Eligibility criteria met