Predictive Clinical Features for Response to Adjuvant Immunotherapy in Stage II,III and IV Resected Melanoma (Mel-ImmAdj)

September 2, 2022 updated by: Hospices Civils de Lyon
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

1000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • France
      • Pierre-Bénite, France, 69310
        • Recruiting
        • Centre hospitalier Lyon Sud
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Stage II, III and IV (resected) melanoma patients treated with surgery and adjuvant immunotherapy in the dermatology unit of Lyon-Sud hospital between January 1st of 2019 and January 1st of 2029, with no residual disease prior to immunotherapy onset.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Other
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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)
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
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)
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
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)
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospices Civils de Lyon

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2019

Primary Completion (Anticipated)

January 1, 2029

Study Completion (Anticipated)

January 1, 2039

Study Registration Dates

First Submitted

May 17, 2022

First Submitted That Met QC Criteria

September 2, 2022

First Posted (Actual)

September 6, 2022

Study Record Updates

Last Update Posted (Actual)

September 6, 2022

Last Update Submitted That Met QC Criteria

September 2, 2022

Last Verified

September 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 616

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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