Clinical trial · Observational
Power of Liquid Biopsy Tracking in Immunotherapy Treated Stage IV Melanoma
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Metastatic Melanoma | Melanoma | CURATED_BROADER | 0.78 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (1)
- label
- Histologically proven melanoma
- description
- Unresectable stage III or stage IV disease, with confirmed radiological disease progression within 1 month of recruitment
Primary outcomes (1)
- measure
- Proportion of patients with measurable ctDNA at the point of radiological disease progression
- timeFrame
- 1 year
- description
- Proportion positive of ctDNA assays vs. standard imaging including CT, MRI or PET scans depending upon site of disease relapse
Secondary outcomes (3)
- measure
- Patient acceptance of liquid biopsy measured by proportion of enrolled patients to those invited to participate in the study
- timeFrame
- 1 year
- description
- Patient satisfaction with using liquid biopsy for each assay measured by a question on satisfaction (Yes/No/Undecided)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 16 Years
Show eligibility criteria text
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
References
Publications (10)
- BACKGROUNDPascual J, Attard G, Bidard FC, Curigliano G, De Mattos-Arruda L, Diehn M, Italiano A, Lindberg J, Merker JD, Montagut C, Normanno N, Pantel K, Pentheroudakis G, Popat S, Reis-Filho JS, Tie J, Seoane J, Tarazona N, Yoshino T, Turner NC. ESMO recommendations on the use of circulating tumour DNA assays for patients with cancer: a report from the ESMO Precision Medicine Working Group. Ann Oncol. 2022 Aug;33(8):750-768. doi: 10.1016/j.annonc.2022.05.520. Epub 2022 Jul 6. PMID 35809752
- BACKGROUNDLarkin J, Chiarion-Sileni V, Gonzalez R, Grob JJ, Rutkowski P, Lao CD, Cowey CL, Schadendorf D, Wagstaff J, Dummer R, Ferrucci PF, Smylie M, Hogg D, Hill A, Marquez-Rodas I, Haanen J, Guidoboni M, Maio M, Schoffski P, Carlino MS, Lebbe C, McArthur G, Ascierto PA, Daniels GA, Long GV, Bastholt L, Rizzo JI, Balogh A, Moshyk A, Hodi FS, Wolchok JD. Five-Year Survival with Combined Nivolumab and Ipilimumab in Advanced Melanoma. N Engl J Med. 2019 Oct 17;381(16):1535-1546. doi: 10.1056/NEJMoa1910836. Epub 2019 Sep 28. PMID 31562797
- BACKGROUNDTeixido C, Castillo P, Martinez-Vila C, Arance A, Alos L. Molecular Markers and Targets in Melanoma. Cells. 2021 Sep 5;10(9):2320. doi: 10.3390/cells10092320. PMID 34571969
- BACKGROUNDLee JH, Menzies AM, Carlino MS, McEvoy AC, Sandhu S, Weppler AM, Diefenbach RJ, Dawson SJ, Kefford RF, Millward MJ, Al-Ogaili Z, Tra T, Gray ES, Wong SQ, Scolyer RA, Long GV, Rizos H. Longitudinal Monitoring of ctDNA in Patients with Melanoma and Brain Metastases Treated with Immune Checkpoint Inhibitors. Clin Cancer Res. 2020 Aug 1;26(15):4064-4071. doi: 10.1158/1078-0432.CCR-19-3926. Epub 2020 Apr 22. PMID 32321716
- BACKGROUNDSyeda MM, Wiggins JM, Corless BC, Long GV, Flaherty KT, Schadendorf D, Nathan PD, Robert C, Ribas A, Davies MA, Grob JJ, Gasal E, Squires M, Marker M, Garrett J, Brase JC, Polsky D. Circulating tumour DNA in patients with advanced melanoma treated with dabrafenib or dabrafenib plus trametinib: a clinical validation study. Lancet Oncol. 2021 Mar;22(3):370-380. doi: 10.1016/S1470-2045(20)30726-9. Epub 2021 Feb 12.