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NCT Number: NCT06710093

Power of Liquid Biopsy Tracking in Immunotherapy Treated Stage IV Melanoma

The advent of immune ICI has remarkably improved survival in advanced melanoma patients in the last decade. Long term responders following 2 years of treatment with immunotherapy go on to surveillance with frequent radiological imaging every 3-6 months up to 5-10 years. This not only exposes patients with a relatively low risk of recurrence to significant amounts of ionising radiation, but also increases the burden and cost on already stretched radiology departments. Therefore, this study aims to assess the feasibility and patient experience of using ctDNA with minimally invasive liquid biopsy assays as a biomarker for detecting disease relapse or progression at the point of radiological progression. Data from this pilot study will help to design a future validation study for establishing optimal liquid biopsy for surveillance in advanced melanoma patients.

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Key information

Conditions

Metastatic Melanoma Melanoma Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Germ Cell and Embryonal Neoplasms, Nerve Tissue Neuroectodermal Tumors Neuroendocrine Tumors Nevi and Melanomas Skin Diseases Skin Neoplasms Skin and Connective Tissue Diseases

Age range

16 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

This prospective study will measure ctDNA in a simple plasma sample and using a dried blood spot assay, collected at the time of radiological disease progression. We will investigate the use of tumour informed and tumour naïve approaches, assessing targeted sequencing, copy number variations using whole genome low depth sequencing, fragmentomics and methylation as potential methods to improve molecular recurrence detection. We will also collect urine samples to investigate the use of cfDNA to detect relapse in the brain, which has been noted to be more challenging to detect using ctDNA in the blood than other sites of relapse.

In addition, we will investigate the use of novel immunophenotyping technology through a collaboration with MelioHealth (IMU) in the same setting. The IMU platform combines high resolution cellular analysis and machine learning to enable high-content, high-throughput and real-time cellular immunophenotyping from less than 2ml of whole blood. We hypothesize that disease relapse following immunotherapy may detectably trigger a patient's immune system memory, which may be particularly important for those patients who do not shed ctDNA.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Histologically proven melanoma
  • Unresectable stage III or stage IV disease, with confirmed radiological disease progression within 1 month of recruitment
  • Patient has received at least 1 cycle of immunotherapy with checkpoint inhibitors for melanoma
  • Undergoing standard of care active treatment with regular interval imaging or routine imaging surveillance following treatment completion/cessation
  • Age over 16
  • Not previously diagnosed with HIV, Hepatitis B or C (does not need testing)

Exclusion criteria

  • Not on routine surveillance with interval imaging per standard of care
  • Unable to provide informed consent due to psychological, medical or cognitive conditions.
  • Unable to comply with schedule of study samples to be collected. Concurrent active malignancies needing treatment

Treatment and study plan

Primary outcomes

  1. Proportion of patients with measurable ctDNA at the point of radiological disease progression

    Time frame: 1 year

    Proportion positive of ctDNA assays vs. standard imaging including CT, MRI or PET scans depending upon site of disease relapse

Secondary outcomes

  1. Patient acceptance of liquid biopsy measured by proportion of enrolled patients to those invited to participate in the study

    Time frame: 1 year

    Patient satisfaction with using liquid biopsy for each assay measured by a question on satisfaction (Yes/No/Undecided)

  2. Cost of standard imaging pathway and additional cost of using liquid biopsy testing

    Time frame: 1 year

    To assess the cost of standard imaging pathway and additional cost of using liquid biopsy testing

  3. Proportion of patients with positive tests in the different liquid biopsy assays to detect disease relapse

    Time frame: 1 year

    To assess the sensitivity of different liquid biopsy assays, including plasma vs blood spot for measuring ctDNA at point of disease progression

Study contacts

Contact information is provided by the study sponsor or research team.

Arjun Modi, MSc

CONTACT

[email protected]

020 7352 8171

Laura Boddy

CONTACT

[email protected]

020 7352 8171

Sponsors and collaborators

Lead sponsor

Royal Marsden NHS Foundation Trust

Other

Registry information

Acronym: PerceIVe

Important dates

Study start
2025
Primary completion
2028
Study completion
2029
First posted
Nov 29, 2024
Registry last updated
Nov 29, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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