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Clinical Trial Finder

Search Results

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

Study Purpose

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

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Observational
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT03771859
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Bristol-Myers Squibb
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Bristol-Myers Squibb
Principal Investigator Affiliation Bristol-Myers Squibb
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Active, not recruiting
Countries Belgium, Luxembourg
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Melanoma
Study Website: View Trial Website
Additional Details

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

Arms & Interventions

Arms

: Participants who initiate adjuvant treatment with nivolumab

Interventions

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Local Institution, Aalst, Belgium

Status

Address

Local Institution

Aalst, , 9300

Local Institution, Antwerpen, Belgium

Status

Address

Local Institution

Antwerpen, , 2020

Local Institution, Bouge, Belgium

Status

Address

Local Institution

Bouge, , 5004

Local Institution, Brugge, Belgium

Status

Address

Local Institution

Brugge, , B-8000

Local Institution, Brussels, Belgium

Status

Address

Local Institution

Brussels, , 1000

Local Institution, Brussel, Belgium

Status

Address

Local Institution

Brussel, , 1090

Local Institution, Edegem, Belgium

Status

Address

Local Institution

Edegem, , 2650

Local Institution, Gent, Belgium

Status

Address

Local Institution

Gent, , 9000

Local Institution, Hasselt, Belgium

Status

Address

Local Institution

Hasselt, , 3500

Local Institution, La Louviere, Belgium

Status

Address

Local Institution

La Louviere, , 7100

Local Institution, Liege, Belgium

Status

Address

Local Institution

Liege, , 4000

Local Institution, Sint-Niklaas, Belgium

Status

Address

Local Institution

Sint-Niklaas, , 9100

Local Institution, Turnhout, Belgium

Status

Address

Local Institution

Turnhout, , 2300

Local Institution, Luxembourg, Luxembourg

Status

Address

Local Institution

Luxembourg, , 1210

Resources

  • Patient and Caregiver Survey
  • Clinical Trial Endpoints
  • Research Resources
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The content provided on clinical trials is for informational purposes only and is not a substitute for medical consultation with your healthcare provider. We do not recommend or endorse any specific study and you are advised to discuss the information shown with your healthcare provider. While we believe the information presented on this website to be accurate at the time of writing, we do not guarantee that its contents are correct, complete, or applicable to any particular individual situation. We strongly encourage individuals to seek out appropriate medical advice and treatment from their physicians. We cannot guarantee the availability of any clinical trial listed and will not be responsible if you are considered ineligible to participate in a given clinical trial. We are also not liable for any injury arising as a result of participation.

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