Clinical trial NCT03771859: A Study of Patients Receiving Adjuvant Nivolumab Therapy for Melanoma That Has Been Removed
Official title: An Observational Study in Patients Receiving Adjuvant Nivolumab Therapy for Resected Melanoma
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Melanoma
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2018-12-11
Enrollment: 152
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: PROBABILITY_SAMPLE
Study population: Adults with melanoma with involvement of lymph nodes or metastatic disease who have undergone complete resection, and who receive adjuvant nivolumab under real-world conditions in Belgium or Luxembourg. Patients will be enrolled after complete surgical resection and following a screen procedure (according to standard practice) that shows no evidence of disease. Patients currently enrolled in an interventional clinical trial will not be eligible.

Brief summary: An observational study of melanoma participants who are eligible for and who have initiated treatment with adjuvant nivolumab as part of routine clinical practice.

Detailed description: Participants receiving adjuvant nivolumab therapy could be enrolled prospectively and retrospectively.

Eligibility criteria: Inclusion Criteria:

* Patients 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
* At least 18 years of age at the time of treatment decision
* Patients who provide written informed consent to participate in the study (for retrospectively enrolled patients who are deceased at time of study start, a consent waiver will be sought)

Exclusion Criteria:

* Any patient with a diagnosis of persisting advanced melanoma prior to first administration of nivolumab
* Any patient 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 Overall Survival (OS)/ Relapse Free Survival (RFS) can be enrolled. In case of a blinded study, the treatment arm needs to be known).

Other protocol defined inclusion/exclusion criteria could apply

Primary outcomes:
measure: RFS (relapse free survival)
timeFrame: 5 years
Secondary outcomes:
measure: DMFS (distant metastasis free survival)
timeFrame: 5 years
measure: OS (overall survival)
timeFrame: 5 years
measure: Distribution of sociodemographic characteristics in participants initiating nivolumab
timeFrame: 5 years
measure: Distribution of clinical characteristics in participants initiating nivolumab
timeFrame: 5 years
measure: Distribution of treatment patterns in participants initiating nivolumab
timeFrame: 5 years
measure: QOL (quality of life) of patients with resected melanoma receiving adjuvant nivolumab therapy by using the EuroQOL-5D (EQ-5D)
timeFrame: 5 years
measure: The European Organization for Research and Treatment of Cancer (EORTC) QLQ C-30 questionnaire
timeFrame: 5 years
measure: Functional Assessment of Cancer Therapy-Melanoma (FACT-M) questionnaires
timeFrame: 5 years
measure: Incidence of AE's
timeFrame: 5 years
measure: Incidence of SAE's
timeFrame: 5 years
Other outcomes:
Locations:
city: Aalst
country: Belgium
facility: Local Institution
city: Antwerpen
country: Belgium
facility: Local Institution
city: Bouge
country: Belgium
facility: Local Institution
city: Brugge
country: Belgium
facility: Local Institution
city: Brussels
country: Belgium
facility: Local Institution
city: Brussel
country: Belgium
facility: Local Institution
city: Edegem
country: Belgium
facility: Local Institution
city: Gent
country: Belgium
facility: Local Institution
city: Hasselt
country: Belgium
facility: Local Institution
city: La Louviere
country: Belgium
facility: Local Institution
city: Liege
country: Belgium
facility: Local Institution
city: Sint-Niklaas
country: Belgium
facility: Local Institution
city: Turnhout
country: Belgium
facility: Local Institution
city: Luxembourg
country: Luxembourg
facility: Local Institution
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: