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

Recruiting · NCT05527795 · Observational (researchers observe without assigning treatment) · Lead sponsor: Hospices Civils de Lyon

View the official record on ClinicalTrials.gov →

Melanoma

Interventions studied

Duration of overall survival according to clinical featuresDuration of relapse-free survival according to clinical featuresFrequency and duration of response to adjuvant immunotherapy according to clinical featuresFrequency of adverse events according to clinical featuresFrequency of each type of relapse (i. e. local, distant, unique or multiple) to adjuvant therapy according to clinical featuresOverall response rate

What this trial is about

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.

Who can take part

Age range

18 Years and older

Sex

All (male and female)

Healthy volunteers

No - a diagnosis or condition is required

Phase

Not specified

Study type

Observational (researchers observe without assigning treatment)

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

Where it is running

1 location listed.

Centre Hospitalier Lyon Sud - Pierre-Bénite, France

Read the full protocol, contacts and eligibility on ClinicalTrials.gov →