Status:
UNKNOWN
A Study of Patients Receiving Adjuvant Nivolumab Therapy for Melanoma That Has Been Removed
Lead Sponsor:
Bristol-Myers Squibb
Conditions:
Melanoma
Eligibility:
All Genders
18+ years
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
- 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
- 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
Key Trial Info
Start Date :
January 16 2019
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 30 2025
Estimated Enrollment :
152 Patients enrolled
Trial Details
Trial ID
NCT03771859
Start Date
January 16 2019
End Date
December 30 2025
Last Update
September 14 2021
Active Locations (14)
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1
Local Institution
Aalst, Belgium, 9300
2
Local Institution
Antwerp, Belgium, 2020
3
Local Institution
Bouge, Belgium, 5004
4
Local Institution
Bruges, Belgium, B-8000