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A Single Arm Trial Evaluating the Efficacy and Safety of EVX-01 in Combination With Pembrolizumab in Adults With Unresectable or Metastatic Melanoma

PHASE2RECRUITING

The purpose of this single arm, multi-national clinical trial in patients with metastatic or unresectable melanoma is to evaluate the BOR and compare it to historical data on patients on anti-PD1 treatment with pembrolizumab alone.

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Study details:

Patients will initiate treatment with pembrolizumab at the start of the trial and receive up to 18 treatment cycles (approximately 2 years). Immunization with the EVX-01 will be initiated at Week 12. In total, 10 doses of EVX-01 will be administered intramuscularly, with 6 doses given two weeks apart and 4 booster doses at later time points.

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Eligibility criteria

Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.

Inclusion criteria

  • Be at least 18 years of age on day of signing informed consent.
  • Histologically confirmed, and not amenable to local therapy, metastatic or unresectable melanoma Stage III or Stage IV, as per AJCC 8th ed. staging system.
  • Patient may not have a diagnosis of uveal or ocular melanoma.
  • Patients must be treatment naïve to checkpoint inhibitor (CPI) therapy
  • Patients must have testing for a BRAF mutation prior to study entry.
  • Have measurable disease per RECIST 1.1 as assessed by the local site investigator within 4 weeks prior to the first visit. Lesions situated in a previously irradiated area are considered measurable if progression has been demonstrated in such lesions.
  • Patients must be willing and able to provide fresh or frozen tumor tissue from an unresectable or metastatic site of disease for neoepitope and biomarker analyses. If a sufficient amount of tumor tissue from an unresectable or metastatic site is not available prior to the start of the screening phase, subjects must consent to allow the acquisition of additional tumor tissue. In addition, participants may provide additional biopsy at the time of discontinuation due to progression.
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
  • Exclusion criteria

  • Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti PD L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (e.g., CTLA-4, OX 40, CD137).
  • Has received prior systemic anti-cancer therapy including investigational agents within 4 weeks prior to treatment.
  • Has received prior radiotherapy within 2 weeks of start of study treatment. Participants must have recovered from all radiation-related toxicities, not require corticosteroids, and not have had radiation pneumonitis. A 1-week washout is permitted for palliative radiation (≤2 weeks of radiotherapy) to non-CNS disease.
  • Has received a live or live-attenuated vaccine within 30 days prior to the first dose of study intervention. Note: Administration of killed vaccines are allowed.
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    Eligibility

    Age eligible for study : 18 and older

    Healthy volunteers accepted : No

    Gender eligible for study: All

    Things to know

    Study dates

    Study start: 2022-08-30

    Primary completion: 2025-06-28

    Study completion finish: 2025-07-25

    study type

    Study type

    TREATMENT

    phase

    Phase

      PHASE2

    trial

    Trial ID

    NCT05309421

    Intervention or treatment

    DRUG: EVX-01

    DRUG: Pembrolizumab 25 MG/ML

    Conditions

    • Melanoma Stage III
    • Melanoma Stage IV

    Find a site

    Closest Location:

    Melanoma Institute Australia

    Research sites nearby

    Select from list below to view details:

    • Melanoma Institute Australia

      Wollstonecraft, New South Wales, Australia

    • Sir Charles Gairdner Hospital

      Nedlands, Western Australia, Australia

    • Ballarat Health Services (Grampians Health)

      Ballarat Central, Victoria, Australia

    • One Clinical Research

      Nedlands, Western Australia, Australia

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    Study Plan

    This section provides details of the study plan, including how the study is designed and what the study is measuring.

    How is the study designed?

    Participant Group/ArmIntervention/Treatment
    EXPERIMENTAL: EVX-01 in combination with pembrolizumab
    • EVX-01 is administered im. Pembrolizumab is administered according to label
    DRUG: EVX-01
    • Investigational drug given in combination with standard of care

    What is the study measuring?

    Primary outcome

    Primary Outcome MeasurePrimary Outcome DescriptionPrimary Outcome Time Frame
    Change in the best overall response (BOR)Composite of a BOR of complete response (CR) or PR for patients with SD at the time of first EVX-01 administration and a BOR of CR for patients with PR at the time of first EVX-01 administration, within 2 years of treatment with pembrolizumab, as per RECIST 1.1 criteriaMeasurements at Baseline through study completion (up to 102 weeks)

    Secondary outcome

    Secondary Outcome MeasureSecondary Outcome DescriptionSecondary Outcome Time Frame
    Change in overall response rateOverall response rate, defined as the proportion of the patients who have best response as CR or PR assessed 2 years after initiation of treatment with pembrolizumab, as per RECIST 1.1 criteriaMeasurements at Baseline through study completion (up to 102 weeks)
    Change in progression free survival (PFS)PFS in patients with an assessment of SD, PR, or CR at the time of first EVX-01 administration, assessed 2 years after initiation of treatment with pembrolizumab and defined as the time from the first EVX-01 administration to the first documented disease progression per RECIST 1.1. criteria or death due to any causes, whichever occurs firstMeasurements at Baseline through study completion (up to 102 weeks)
    Change in overall survival (OS)OS assessed 2 years after initiation of treatment with pembrolizumab and defined as the time from initiation of treatment of pembrolizumab to death due to any causeMeasurements at Baseline through study completion (up to 102 weeks)
    Number, type and severity of adverse events (AEs) and serious adverse events (SAEs)Number, type and severity of adverse events (AEs) and serious adverse events (SAEs) to evaluate the safety of EVX-01 in patients with metastatic or unresectable melanoma on pembrolizumab treatmentMeasurements at Baseline through study completion (up to 102 weeks)
    Immunologic response induced by EVX-01Activation and level of neoepitope specific CD4+ and CD8+ T-cells before, during and after EVX-01 immunizationMeasurements at Baseline through study completion (up to 102 weeks)
    Percentage of patients in which EVX-01 is generated, produced, and administeredPercentage of patients in which EVX-01 is generated, produced, and administered to evaluate the manufacturing feasibility of EVX-01From tumor biopsy sampling to first dose of EVX-01 (up to 16 weeks)

    Frequently Asked Questions

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    References

    Clinical Trials Gov: A Single Arm Trial Evaluating the Efficacy and Safety of EVX-01 in Combination With Pembrolizumab in Adults With Unresectable or Metastatic Melanoma

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