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

NCT05527795 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 1000

Last updated 2022-09-06

No results posted yet for this study

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.

Conditions

Interventions

OTHER

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

* 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

OTHER

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

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

OTHER

Duration of relapse-free survival according to clinical features

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

OTHER

Duration of overall survival according to clinical features

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.

OTHER

Overall response rate

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.

OTHER

Frequency of adverse events according to clinical features

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

Sponsors & Collaborators

  • Hospices Civils de Lyon

    lead OTHER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-01-01
Primary Completion
2029-01-01
Completion
2039-01-01

Countries

  • France

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05527795 on ClinicalTrials.gov