LATe TreatmENT Related Toxicity in Melanoma (LATENT)

NCT06414343 | Not Yet Recruiting

• 1 other identifier: CCR6009
• Study Type: observational
• Target: 400
• Locations: 1 country
• Sites: 1

Brief Summary

Recent improvements in advanced melanoma treatment with immunotherapy have dramatically improved patient survival. Longer survival however has come at a cost of toxicity. Short term side effects can occur in \>50% of patients undergoing immunotherapy treatment; however, many long-term survivors are also living with serious consequences of these treatments which may be under reported in literature. Data regarding long term toxicities, from these treatments is lacking and an area of important unmet clinical need. Therefore, in collaboration with the Clatterbridge and Christie's teams, the investigators propose to retrospectively analyse the nature, incidence, frequency, and severity of immune related toxicities in around 400 patients who received immunotherapy for advanced melanoma with ongoing durable responses to treatment of at least 3 years. The investigators will set up a collective anonymized database and record this information through review of electronic medical records of patients that meet the eligibility criteria. The investigators will also review the patterns of use of long-term immunosuppression and assess the need for specialist referrals for managing late side effects. The investigators hope that this data will help us address gaps in the management of long-term survivors by identifying areas of need and establishing a coordinated evidence based multidisciplinary service to provide personalised, risk stratified long term follow up.

Conditions

Melanoma

Outcome Measures

Primary Outcomes (1)

• To describe patterns of a range of medical late toxicities following immunotherapy treatment for advanced melanoma patients

  • Descriptive analysis of proportion of patients (%) developing immune related adverse events in those with advanced melanoma with ongoing response of at least 3 years following treatment with immune checkpoint inhibitors. Description of severity of each type of toxicity and adverse events experienced in the overall population measured as Grade 1-5 as per Common Terminology Criteria for Adverse Events (CTCAE v5.0).

  12 months

Secondary Outcomes (3)

• Exploration of differences in proportions of patients

  12 months

• Time to occurrence of irAEs

  12 months

• Descriptive analyses of the frequency of use of immunosuppressive agents

  12 months

Interventions

Observational - no intervention OTHER

Observational - no intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

This will be a collaborative multicentre non-interventional retrospective analysis of pre-recorded data collected from patient medical records by direct treating teams. The participants will be patients of at least age 18, treated for advanced and metastatic melanoma between 2005-2020 with immune checkpoint inhibitors and have ongoing response to treatment (either stable disease, partial or complete response per RECIST 1.1) for at least 3 years at the time of inclusion in the study. Patients with metastatic melanoma treated with immunotherapy will be identified from the electronic hospital records by treating clinical teams/research team at each centre and screened for eligibility.

You may qualify if:

• Histological diagnosis of melanoma
• Age 18 years or older
• Treated between January 2005- December 2020 with immune checkpoint inhibitor therapy including either Pembrolizumab, Nivolumab, Ipilimumab or combinations, for advanced melanoma (unresectable stage III or stage IV)
• Ongoing response to therapy of at least 3 years duration at point of study entry

You may not qualify if:

• Diagnoses of other concurrent malignancies needing active treatment
• Received Immune checkpoint inhibitors for non-metastatic melanoma or in the adjuvant setting only.
• Received other treatments including targeted therapy as the most recent line of treatment or following immunotherapy.
• Progression of disease on or following immunotherapy

Sponsors & Collaborators

• Royal Marsden NHS Foundation Trust: lead

Study Sites (1)

Royal Marsden NHS Foundation Trust

Chelsea, London, SW3 6JJ, United Kingdom

Location

MeSH Terms

Conditions

Melanoma

Condition Hierarchy (Ancestors)

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

Study Officials

• Kate Young, MD

  Royal Marsden NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Arjun Modi

CONTACT

020 7352 8171; arjun.modi@rmh.nhs.uk

Sowmya Cheruvu, MD

CONTACT

020 7352 8171; sowmya.cheruvu@rmh.nhs.uk

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 24, 2024
• First Posted: May 16, 2024
• Study Start: December 1, 2024
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2024
• Last Updated: June 25, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)