A Prospective Non-Interventional Study in Participants Receiving Nivolumab in Adjuvant Setting for Resected Melanoma in Real-World Conditions in France (AdjuMel)

A National, Prospective, Non- Interventional Study (NIS) in Patients Receiving Adjuvant Nivolumab Therapy for Resected Melanoma and Subsequent Treatments in Case of Relapse

This is an observational prospective study to estimate in real world conditions the effectiveness, the safety profile and the pattern of use of adjuvant nivolumab in adults participants with stage III/IV resected melanoma, and subsequent treatments administered in case of relapse.

Study Overview

• Status: Active, not recruiting
• Conditions: Melanoma

• Study Type: Observational
• Enrollment (Actual): 362

Contacts and Locations

Study Locations

• France
  • Lille, France, 59000
    • Local Institution

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

The study will collect data primarily from hospital based dermatology and oncology care facilities

Description

For more information regarding Bristol-Myers Squibb Clinical Trial participation,please visit www.BMSStudyConnect.com.

Inclusion Criteria:

• Participants with a primary diagnosis of melanoma with involvement of lymph nodes or metastatic disease who have undergone complete resection and have no evidence of disease
• Decision to treat with adjuvant nivolumab therapy has already been taken
• Participants who provide oral informed consent to participate in the study

Exclusion Criteria:

• Any participant with a current diagnosis of persisting advanced melanoma
• Participants with a current primary diagnosis of a cancer other than advanced melanoma, ie, a cancer other than melanoma that requires systemic or other treatment or has not been treated curatively (as per discretion of the investigator)
• Any participants currently enrolled in an interventional clinical trial for his/her melanoma treatment (note: patients who have completed their participation in an interventional trial or who are no longer receiving the study drug and are only followed up for OS/RFS can be enrolled. In case of a blinded study, the treatment arm needs to be known).
• Pregnant women
• Person under guardianship

Other protocol defined inclusion/exclusion criteria apply

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Nivolumab treatment; Administered according to the market authorization in France

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Relapse-Free Survival (RFS)	up to 60 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Progression Free Survival (PFS)	Up to 60 months
Overall Survival (OS)	Up to 60 months
Distant Metastatasis-Free Survival (DMFS)	Up to 60 months
Relapse-Free Survival 2 (RFS2)	Up to 60 months
Assessment of health related quality of life	Up to 60 Months
Assessment of sociodemographic characteristics	Up to 60 months
Assessment of clinical characteristics	Up to 60 months
Frequency of nivolumab therapy: number of infusions	Up to 60 months
Frequency of nivolumab therapy: number of dosing	Up to 60 months
Frequency of Nivolumab: pattern of use	Up to 60 months
Characteristics of nivolumab adjuvant safety profile: incidence	Up to 60 months
Characteristics of nivolumab adjuvant safety profile: grade	Up to 60 months
Characteristics of nivolumab adjuvant safety profile: type	Up to 60 months
Characteristics of nivolumab adjuvant safety profile: time to onset of select AEs	Up to 60 months
Characteristics of nivolumab adjuvant safety profile: time to onset of other immune- related AEs	Up to 60 months
Characteristics of nivolumab adjuvant safety profile: time to resolution of select AEs	Up to 60 months
Characteristics of nivolumab adjuvant safety profile: time to resolution of other immune-related AEs	Up to 60 months
Describe the use of subsequent therapies after relapse following adjuvant nivolumab	Up to 60 months
Estimate of the effectiveness of systemic therapies administered after relapse following adjuvant nivolumab, in terms of time and duration of response	Up to 60 months
Estimate of the effectiveness of systemic therapies administered after relapse following adjuvant nivolumab, in terms of overall response rate	Up to 60 months
Safety profile of systemic therapies administered after relapse in terms of severe adverse events incidence, type, management and outcome	Up to 60 months
Estimate the effectiveness of subsequents treatments administered after relapse in terms of PFS	Up to 60 months
Estimate the effectiveness of subsequents treatments administered after relapse in terms of RFS2	Up to 60 months
Estimate the effectiveness of subsequents treatments administered after relapse in terms of OS	Up to 60 months
Characteristics of nivolumab adjuvant safety profile: management	Up to 60 months
Characteristics of nivolumab adjuvant safety profile: outcome	Up to 60 months
Safety profile of systemic therapies administered after relapse in terms of severe adverse events: Incidence	Up to 60 months
Safety profile of systemic therapies administered after relapse in terms of severe adverse events: Type	Up to 60 months
Safety profile of systemic therapies administered after relapse in terms of severe adverse events: Management	Up to 60 months
Safety profile of systemic therapies administered after relapse in terms of severe adverse events: Outcome	Up to 60 months

Collaborators and Investigators

• Sponsor: Bristol-Myers Squibb

Publications and helpful links

Helpful Links

• BMS Clinical Trial Information
• FDA Safety Alerts and Recalls

Study record dates

Study Major Dates

• Study Start (Actual): September 2, 2020
• Primary Completion (Anticipated): March 15, 2027
• Study Completion (Anticipated): March 15, 2027

Study Registration Dates

• First Submitted: September 9, 2020
• First Submitted That Met QC Criteria: September 9, 2020
• First Posted (Actual): September 16, 2020

Study Record Updates

• Last Update Posted (Actual): March 21, 2022
• Last Update Submitted That Met QC Criteria: March 17, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Neuroendocrine Tumors; Nevi and Melanomas; Melanoma
• Other Study ID Numbers: CA209-7HU