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

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Observational
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
View:

• 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

Locations
Other Locations
France
Centre Hospitalier Lyon Sud
RECRUITING
Pierre-bénite
Contact Information
Primary
Stéphane Dalle, PhD
stephane.dalle@chu-lyon.fr
+(33)478861679
Time Frame
Start Date: 2019-01-01
Estimated Completion Date: 2039-01-01
Participants
Target number of participants: 1000
Treatments
Non-mutated
Non mutated (BRAF or NRAS) stage II, III or IV (resected) melanoma patients treated with first line adjuvant immunotherapy (anti-PD-1 with either pembrolizumab or nivolumab)
BRAF-mutated
BRAF-mutated stage II, III or IV (resected) melanoma patients treated with first line adjuvant immunotherapy (anti-PD-1 with either pembrolizumab or nivolumab)
NRAS-mutated
NRAS-mutated (BRAF or NRAS) stage II, III or IV (resected) melanoma patients treated with first line adjuvant immunotherapy (anti-PD-1 with either pembrolizumab or nivolumab)
Related Therapeutic Areas
Sponsors
Leads: Hospices Civils de Lyon

This content was sourced from clinicaltrials.gov