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NCT Number: NCT05527795

Predictive Clinical Features for Response to Adjuvant Immunotherapy in Stage II,III and IV Resected Melanoma

Surgical excision is the treatment of choice for stage II, III and resectable stage IV melanoma and is curative in most cases. Given the recent success of immunotherapy for the treatment of patients with advanced metastatic melanoma, the use of immunotherapy has been evaluated in the adjuvant setting for patients at high risk of recurrence. In this context, Nivolumab prolonged Recurrence-Free Survival (RFS) while reducing toxicity compared with Ipilimumab in a phase III clinical trial, and was subsequently FDA-approved in December 2017 for adjuvant treatment of locally advanced melanoma with metastatic lymph node involvement after resection of cutaneous lesions. While a fraction of patients benefit from adjuvant PD-1 immunotherapy, approximately 40% of patients are still relapsing despite this adjuvant treatment, without being able to identify them early and with poor understanding of resistance mechanisms. Additionally, about 15% of the patients will develop serious adverse effects driven by immunotherapy and often discontinuing or even contraindicating the onset of subsequent treatments, hence affecting global patients care. It is therefore of prime importance to identify clinical features able to predict response and toxicities to adjuvant immunotherapy in melanoma.

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Key information

Conditions

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

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Centre Hospitalier Lyon Sud

Pierre-Bénite, 69310, France

Location status: Recruiting

Location contact

Stéphane Dalle, MD, PhD

CONTACT

[email protected]

+(33)478861679

Who can participate

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

Inclusion criteria

  • Patients diagnosed with stage II, III or IV (resected) melanoma
  • Treated by surgery and adjuvant immunotherapy between January 1st of 2019 and January 1st of 2029
  • Gave informed consent to allow the use of biological samples for research purpose
  • Has read the information sheet regarding this study
  • With tumor samples available at the biobank center

Exclusion criteria

  • Patients under 18 years old
  • Patients placed under the judicial protection
  • Opposed to this study

Treatment and study plan

Frequency and duration of response to adjuvant immunotherapy according to clinical features

Other
  • Frequency of relapse to adjuvant immunotherapy according to clinical features
  • Duration of relapse as defined by the time (days) between adjuvant immunotherapy onset and relapse date according to clinical features

Frequency of each type of relapse (i. e. local, distant, unique or multiple) to adjuvant therapy according to clinical features

Other

Percentages of each type of relapse (i. e. local, distant, unique or multiple) according to clinical features

Duration of relapse-free survival according to clinical features

Other

Duration of relapse-free survival as defined by the time (days) between adjuvant immunotherapy onset and relapse date.

Duration of overall survival according to clinical features

Other

Duration of relapse-free survival as defined by the time (days) between adjuvant immunotherapy onset and the date of death (irrespectively of the cause) 10 years after inclusion in the study. Alive or lost to follow-up patients will be censored at the date of the last follow-up visit.

Overall response rate

Other

Response rate to adjuvant immunotherapy and to treatment lines subsequent to relapse. Response rate to adjuvant immunotherapy is defined by the absence of relapse as assessed by the physician following the first year of adjuvant therapy. Response to treatment after relapse is defined as partial or complete response as assessed by the physician following the first year of adjuvant therapy.

Frequency of adverse events according to clinical features

Other

Rate of adverse events according to their nature and grade (as defined by CTCAE V 5.0) and according to clinical features

Primary outcomes

  1. Duration of response to adjuvant immunotherapy according to clinical features.

    Time frame: 1 year

    • Duration of response as defined by the time (days) between adjuvant immunotherapy onset and relapse date according to clinical features.

Study contacts

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

Stéphane Dalle, PhD

CONTACT

[email protected]

+(33)478861679

Sponsors and collaborators

Lead sponsor

Hospices Civils de Lyon

Other

Registry information

Acronym: Mel-ImmAdj

Important dates

Study start
2019
Primary completion
2029
Study completion
2039
First posted
Sep 6, 2022
Registry last updated
Sep 6, 2022

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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