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Trial record 50 of 2318 for:    melanoma

The Effectiveness of Nivolumab Monotherapy as First-Line Therapy in Adults With Advanced Melanoma in Germany

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03205722
Recruitment Status : Not yet recruiting
First Posted : July 2, 2017
Last Update Posted : October 4, 2017
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
A retrospective, observational study based on chart reviews for patients with advanced melanoma treated with nivolumab monotherapy prescribed as first-line therapy between June 2015 and June 2016, conducted in a representative sample of sites in Germany.

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

Study Design

Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: The Effectiveness of Nivolumab (OPDIVO®) Monotherapy as First-Line Therapy in Adults With Advanced (Unresectable or Metastatic) Melanoma: An Early Retrospective, Observational Study in Germany
Anticipated Study Start Date : November 1, 2017
Estimated Primary Completion Date : January 31, 2018
Estimated Study Completion Date : January 31, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Melanoma
Drug Information available for: Nivolumab
U.S. FDA Resources

Groups and Cohorts

Group/Cohort Intervention/treatment
Melanoma patients with 1st-line Nivo treatment
Non-Interventional. Patients with advanced melanoma treated with nivolumab monotherapy prescribed as first-line therapy between June 2015 and June 2016.
Other: Non-Interventional
Non-Interventional


Outcome Measures

Primary Outcome Measures :
  1. Overall Survival (OS) [ Time Frame: Approximately 23 months ]
    OS for adult patients with advanced (unresectable or metastatic) melanoma treated with nivolumab monotherapy as first-line therapy from date of advanced diagnosis, and from the start of treatment with nivolumab over the first 23 months after treatment initiation, overall.


Secondary Outcome Measures :
  1. OS from date of advanced diagnosis [ Time Frame: Approximately 23 months ]
  2. progression-free survival (PFS) [ Time Frame: Approximately 23 months ]
  3. best overall response rate (BORR) [ Time Frame: Approximately 23 months ]
  4. best overall response (BOR) [ Time Frame: Approximately 23 months ]
  5. Distribution of Best Overall Response (BOR) by Severity of melanoma at initiation of treatment [ Time Frame: Approximately 23 months ]
  6. Best Overall Response (BOR) in patients greater than or equal to 65 years old [ Time Frame: Approximately 23 months ]
  7. Best Overall Response (BOR) in Eastern Cooperative Oncology Group (ECOG) performance status greater than or equal to 2 [ Time Frame: Approximately 23 months ]
  8. Distribution of Best Overall Response (BOR) by Mutational status [ Time Frame: Approximately 23 months ]
  9. Best Overall Response (BOR) in Patients with brain metastases [ Time Frame: Approximately 23 months ]
  10. Distribution of Best Overall Response (BOR) by Melanoma subtype [ Time Frame: Approximately 23 months ]
  11. Distribution of incidence of Adverse Events (AEs) [ Time Frame: Approximately 23 months ]
  12. Distribution of severity of Adverse Events (AEs) [ Time Frame: Approximately 23 months ]
  13. Distribution of management of Adverse Events (AEs) [ Time Frame: Approximately 23 months ]
  14. Distribution of socio-demographic characteristics in adult patients with advanced melanoma treated with nivolumab monotherapy as first-line therapy [ Time Frame: Approximately 23 months ]
    Socio-demographic characteristics (Gender, Height, Weight, Age) will be summarized using descriptive statistics

  15. Distribution of clinical characteristics in adult patients with advanced melanoma treated with nivolumab monotherapy as first-line therapy [ Time Frame: Approximately 23 months ]
    Clinical characteristics (Initial Diagnosis of melanoma, Histological subtypes, Performance status, Comorbidities, history of cancer) will be summarized using descriptive statistics

  16. Distribution of Treatment Patterns [ Time Frame: Approximately 23 months ]
    Details on Prior and Evolution of Current Treatment Patterns will be summarized using descriptive statistics.

  17. Distribution of Healthcare Resource Utilization [ Time Frame: Approximately 23 months ]
    Healthcare Resource Utilization will be summarized using descriptive statistics

  18. Duration of nivolumab treatment [ Time Frame: Approximately 23 months ]

Eligibility Criteria

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
all patients diagnosed with advanced melanoma who were initiated with nivolumab monotherapy as their first-line therapy in Germany between June 2015 and June 2016.
Criteria

Inclusion Criteria:

  • Adult patients with a primary diagnosis of advanced melanoma (histologically confirmed stage III [unresectable] or stage IV skin, ocular, or mucosal melanoma)
  • Newly initiated with nivolumab monotherapy as their first-line therapy for previously untreated advanced melanoma between June 2015 and June 2016
  • At least 18 years of age at time of treatment decision

Exclusion Criteria:

  • Patients with a current primary diagnosis of a cancer other than advanced melanoma ie, a cancer other than melanoma that requires systemic or other treatment
  • Patients currently included in an interventional clinical trial for his/her locally advanced or metastatic melanoma. Patients who have completed their participation in an interventional trial; or who are not receiving study drug anymore and who are only followed-up for overall survival can be enrolled. In case of a blinded study, the treatment arm (ie, type of administered treatment) needs to be known.
  • Patients < 18 years of age at time of treatment initiation

Other protocol defined inclusion/exclusion criteria could apply

Contacts and Locations

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): NCT03205722


Contacts
Contact: Recruiting sites have contact information. Please contact the sites directly. If there is no contact information, please email: Clinical.Trials@bms.com
Contact: First line of the email MUST contain NCT # and Site #

Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
More Information

Additional Information:
Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT03205722     History of Changes
Other Study ID Numbers: CA209-939
First Posted: July 2, 2017    Key Record Dates
Last Update Posted: October 4, 2017
Last Verified: October 2017

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