An Observational Study of Adjuvant (Post-surgery) Therapy With Nivolumab for Resected (Completely Removed) Melanoma in Australia

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

COMPLETED

Total Enrollment

150 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-12-12

Study Completion Date

2024-05-31

Brief Summary

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This study is designed to estimate the effectiveness of nivolumab when given to participants after removing their cancer with surgery, over a 5-year follow-up, in real-world conditions in Australia.

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Detailed Description

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Conditions

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Melanoma

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Adjuvant nivolumab therapy

Participants receiving nivolumab as an adjuvant therapy according to the market authorization in Australia

nivolumab

Intervention Type DRUG

Administered as adjuvant therapy as per the market authorization in Australia

Interventions

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nivolumab

Administered as adjuvant therapy as per the market authorization in Australia

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Adults with a primary diagnosis of melanoma with involvement of lymph nodes or metastatic disease who have undergone complete surgical removal and have no evidence of disease
* Decision to treat with adjuvant nivolumab therapy has already been taken
* Ability to provide written informed consent to participate in the study

Exclusion Criteria

* Adults with a current diagnosis of persisting advanced melanoma
* Adults currently enrolled in an interventional clinical trial for his/her melanoma treatment

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No