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Completed

NCT Number: NCT03504696

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

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.

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Key information

Conditions

Melanoma Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Germ Cell and Embryonal Neoplasms, Nerve Tissue Neuroectodermal Tumors Neuroendocrine Tumors Nevi and Melanomas Skin Diseases Skin Neoplasms Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Local Institution

Nantes, 44093, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Non-Interventional

Other

Non-interventional

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study 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

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Apr 20, 2018
Registry last updated
Apr 27, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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