A Study of Patients Receiving Adjuvant Nivolumab Therapy for Melanoma That Has Been Removed

Melanoma Clinical Trial

Official title:

An Observational Study in Patients Receiving Adjuvant Nivolumab Therapy for Resected Melanoma

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03771859
• Other study ID #: CA209-8RX
• Status: Active, not recruiting
• Start date: January 16, 2019
• Est. completion date: December 30, 2025

Study information

• Verified date: September 2021
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 152
• Est. completion date: December 30, 2025
• Est. primary completion date: December 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Melanoma

Locations

Country	Name	City	State
Belgium	Local Institution	Aalst
Belgium	Local Institution	Antwerpen
Belgium	Local Institution	Bouge
Belgium	Local Institution	Brugge
Belgium	Local Institution	Brussel
Belgium	Local Institution	Brussels
Belgium	Local Institution	Edegem
Belgium	Local Institution	Gent
Belgium	Local Institution	Hasselt
Belgium	Local Institution	La Louviere
Belgium	Local Institution	Liege
Belgium	Local Institution	Sint-Niklaas
Belgium	Local Institution	Turnhout
Luxembourg	Local Institution	Luxembourg

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Countries where clinical trial is conducted

Belgium,  Luxembourg, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	RFS (relapse free survival)		5 years
Secondary	DMFS (distant metastasis free survival)		5 years
Secondary	OS (overall survival)		5 years
Secondary	Distribution of sociodemographic characteristics in participants initiating nivolumab		5 years
Secondary	Distribution of clinical characteristics in participants initiating nivolumab		5 years
Secondary	Distribution of treatment patterns in participants initiating nivolumab		5 years
Secondary	QOL (quality of life) of patients with resected melanoma receiving adjuvant nivolumab therapy by using the EuroQOL-5D (EQ-5D)	The EQ-5D is a standardized 3-level, 5-dimensional multi-attribute utility questionnaire that measures mobility, self-care, usual activities, pain/discomfort and anxiety/depression, where each dimension is rated by individuals as no problems, slight problems, moderate problems, severe problems, and extreme problems.	5 years
Secondary	The European Organization for Research and Treatment of Cancer (EORTC) QLQ C-30 questionnaire	The EORTC-QLQ-C30 questionnaire is a 30-item instrument that comprises 5 functional scales (physical functioning, cognitive functioning, emotional functioning, social functioning and global quality of life) as well as nine symptom scales (fatigue, pain, nausea/vomiting, dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties).	5 years
Secondary	Functional Assessment of Cancer Therapy-Melanoma (FACT-M) questionnaires	The FACT-M is a frequently used melanoma specific questionnaire which has been validated to assess HRQOL for patients with all stages of melanoma. Besides general questions on Physical Well-Being, Social/Family Well-Being, Emotional Well-Being, and Functional Well-Being, it also contains specific questions related to melanoma, including a subscale on the melanoma surgery	5 years
Secondary	Incidence of AE's		5 years
Secondary	Incidence of SAE's		5 years

External Links

•   BMS Clinical Trial Information
•   FDA Safety Alerts and Recalls