NCT04550247Active, not recruiting
A Prospective Non-Interventional Study in Participants Receiving Nivolumab in Adjuvant Setting for Resected Melanoma in Real-World Conditions in France
A National, Prospective, Non- Interventional Study (NIS) in Patients Receiving Adjuvant Nivolumab Therapy for Resected Melanoma and Subsequent Treatments in Case of Relapse
Source: ClinicalTrials.gov · Last updated 21 Mar 2022 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
This is an observational prospective study to estimate in real world conditions the effectiveness, the safety profile and the pattern of use of adjuvant nivolumab in adults participants with stage III/IV resected melanoma, and subsequent treatments administered in case of relapse.
- Status (registry)
- Active, not recruiting
- Study type
- Observational
- Enrollment
- 362 (actual)
- First submitted
- 9 Sept 2020
- Start date
- 2 Sept 2020
- Primary completion date
- 15 Mar 2027
- Lead sponsor
- Bristol-Myers Squibb
- Diseases
- Melanoma
- NCT number
- NCT04550247
What you commit to
- Study type: Observational
- Participants enrolled: 362
- From 2 Sept 2020 to the primary completion date, 15 Mar 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Any participants 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 OS/RFS can be enrolled. In case of a blinded study, the treatment arm needs to be known).
Other illness
- Participants with a current primary diagnosis of a cancer other than advanced melanoma, ie, a cancer other than melanoma that requires systemic or other treatment or has not been treated curatively (as per discretion of the investigator)
Other
- Any participant with a current diagnosis of persisting advanced melanoma
- Pregnant women
- Person under guardianship
- Other protocol defined inclusion/exclusion criteria apply
Who the study is looking for
- Participants 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
- Participants who provide oral informed consent to participate in the study
Criteria the registry did not label
- For more information regarding Bristol-Myers Squibb Clinical Trial participation,please visit www.BMSStudyConnect.com.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Local Institution Coordinator of this site? Confirm its status | Lille | France | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.