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

RecruitingOBSERVATIONAL
Enrollment

1,000

Participants

Timeline

Start Date

January 1, 2019

Primary Completion Date

January 1, 2029

Study Completion Date

January 1, 2039

Conditions
Melanoma
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

Trial Locations (1)

69310

RECRUITING

Centre Hospitalier Lyon Sud, Pierre-Bénite

All Listed Sponsors
lead

Hospices Civils de Lyon

OTHER