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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

152 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-01-16

Study Completion Date

2025-12-30

Brief Summary

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

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Detailed Description

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

Conditions

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Melanoma

Study Design

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Observational Model Type

COHORT

Study Time Perspective

OTHER

Study Groups

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Participants who initiate adjuvant treatment with nivolumab

No interventions assigned to this group

Eligibility Criteria

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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).

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No