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Effectiveness, Safety and Use of Nivolumab Administered During the French Temporary Authorization for Use in Patients With Advanced Melanoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03504696
Recruitment Status : Completed
First Posted : April 20, 2018
Last Update Posted : April 27, 2018
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb

Brief Summary:
This study will be conducted with the aim of estimating the effectiveness, safety, patterns of use of nivolumab, and characteristics of patients with unresectable or metastatic melanoma, treated with nivolumab monotherapy in the ATU setting.

Condition or disease Intervention/treatment
Melanoma Other: Non-interventional

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Study Type : Observational
Actual Enrollment : 400 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Effectiveness, Safety and Use of Nivolumab Administered During the French Temporary Authorization for Use in Patients With Advanced (Unresectable or Metastatic) Melanoma: A Multicentric, Observational Study
Actual Study Start Date : December 20, 2016
Actual Primary Completion Date : February 20, 2018
Actual Study Completion Date : February 20, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Melanoma
Drug Information available for: Nivolumab

Group/Cohort Intervention/treatment
Patients with Advanced Melanoma
RIC-Mel patients with advanced (unresectable or metastatic) melanoma treated with nivolumab in the context of nivolumab ATU program (occurred from 12-Sep-2014 to 31-Aug-2015)
Other: Non-interventional
Non-interventional




Primary Outcome Measures :
  1. Overall survival (OS) at 1 year [ Time Frame: at 1 year ]
    Overall survival (OS) for adult patients with advanced (unresectable or metastatic) melanoma treated with nivolumab in the ATU (Temporary Authorization for Use) program

  2. Distribution of demographic characteristics of patients with advanced melanoma treated with nivolumab monotherapy in the ATU program [ Time Frame: at baseline ]
    Distribution of demographic characteristics of patients with advanced melanoma treated with nivolumab monotherapy in the ATU program using descriptive statistics

  3. Distribution of clinical characteristics in patients with advanced melanoma treated with nivolumab monotherapy [ Time Frame: at baseline ]
    Clinical characteristics will be summarized using descriptive statistics.

  4. Overall survival (OS) at 2 years [ Time Frame: at 2 years ]
    Overall survival (OS) for adult patients with advanced (unresectable or metastatic) melanoma treated with nivolumab in the ATU (Temporary Authorization for Use) program


Secondary Outcome Measures :
  1. Progression-free survival (PFS) [ Time Frame: 1 year and 2 years ]
    (PFS) will be measured by the time since nivolumab initiation to either the first disease progression date or last known tumor assessment date, or death

  2. Objective response rate (ORR) [ Time Frame: 1 year and 2 years ]
    ORR is the proportion of patients with an objective response. Objective response is measured by the sum of partial responses plus complete responses as assessed by (RECIST 1.1) Response Evaluation Criteria In Solid Tumors

  3. Progression-free survival (PFS) as assessed by RECIST 1.1 [ Time Frame: at 1 year ]
    PFS measured by time since index date (initial treatment with nivolumab) to either the first disease progression date or last known tumor assessment date, or death due to any cause, whichever occurs first as assessed by RECIST 1.1

  4. Distribution of treatment patterns [ Time Frame: up to 2 years ]
    Details on Prior and Evolution of Current Treatment Patterns will be summarized using descriptive statistics.

  5. Incidence of select Grade 3, 4, or 5 adverse events (AEs) [ Time Frame: up to 2 years ]
    Select AEs include pulmonary, endocrine, gastrointestinal, hepatic, renal, cutaneous, and infusion reactions



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
RIC-Mel patients with advanced (unresectable or metastatic) melanoma treated with nivolumab in the context of nivolumab ATU program (occurred from 12-Sep-2014 to 31-Aug-2015).
Criteria

Inclusion Criteria:

  • Patients included in RIC-Mel Database:

    • Diagnosed with melanoma and cared for in the participating sites
    • Patients who have been given appropriate information about RIC-Mel Database aims and who have provided their written consent for data collection and processing before any data collection is carried out
  • Patients included in French nivolumab ATU program

Exclusion Criteria:

• Patients included in RIC-Mel database having initiated nivolumab before 12-Sep-2014 or after 31-Aug-2015, or in the context of a clinical trial

Other protocol defined inclusion/exclusion criteria could apply


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03504696


Locations
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France
Local Institution
Nantes Cedex 1, France, 44093
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
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Study Director: Bristol-Myers Squibb Bristol-Myers Squibb

Additional Information:
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Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT03504696     History of Changes
Other Study ID Numbers: CA209-555
First Posted: April 20, 2018    Key Record Dates
Last Update Posted: April 27, 2018
Last Verified: April 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Melanoma
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Nevi and Melanomas
Nivolumab
Antineoplastic Agents, Immunological
Antineoplastic Agents