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Real-Life Efficacy and Safety of Nivolumab Monotherapy or in Combination With Ipilimumab in Patients With Advanced (Unresectable or Metastatic) Melanoma and in Patients With Adjuvant Nivolumab Therapy (NICO)

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ClinicalTrials.gov Identifier: NCT02990611
Recruitment Status : Recruiting
First Posted : December 13, 2016
Last Update Posted : October 19, 2018
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb

Brief Summary:
Real-Life Efficacy and Safety of Nivolumab monotherapy or in combination with Ipilimumab in patients with Advanced (Unresectable or Metastatic) Melanoma and in patients with adjuvant Nivolumab therapy

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

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Study Type : Observational
Estimated Enrollment : 800 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: A National Prospective, Non-interventional Study (NIS) of Nivolumab (BMS-936558 Monotherapy or in Combination With Ipilimumab in Patients With Advanced (Unresectable or Metastatic) Melanoma and in Patients With Adjuvant Nivolumab Therapy
Actual Study Start Date : December 5, 2016
Estimated Primary Completion Date : August 31, 2024
Estimated Study Completion Date : December 31, 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Melanoma

Group/Cohort Intervention/treatment
Nivolumab monotherapy
Patients who start treatment with nivolumab monotherapy for the first time
Other: Non_Interventional
Non-Interventional

Nivolumab/Ipilimumab combination therapy
Patients who start treatment with the combination therapy of nivolumab with ipilimumab
Other: Non-Interventional
Non-Interventional

Adjuvant Nivolumab therapy
Patients who start adjuvant therapy with nivolumab after complete tumor resection
Other: Non-Interventional
Non-Interventional




Primary Outcome Measures :
  1. Overall Survival (OS) of nivolumab/ipilimumab combination therapy [ Time Frame: 5 years ]
    For cohorts 1 and 2

  2. Relapse Free Survival (RFS) of nivolumab adjuvant therapy [ Time Frame: 5 years ]
    Adjuvant cohort


Secondary Outcome Measures :
  1. Overall Survival (OS) of nivolumab monotherapy [ Time Frame: 5 years ]
  2. Progression-Free Survival (PFS) [ Time Frame: 5 years ]
  3. Overall response rate (ORR) [ Time Frame: 5 years ]
  4. Best Overall Response (BOR) [ Time Frame: 5 years ]
  5. Best Overall Response Rate (BORR) [ Time Frame: 5 years ]
  6. Distribution of Gender in adult patients with advanced Melanoma initiating nivolumab monotherapy [ Time Frame: 5 years ]
  7. Distribution of Height in adult patients with advanced Melanoma initiating nivolumab monotherapy [ Time Frame: 5 years ]
  8. Distribution of Weight in adult patients with advanced Melanoma initiating nivolumab monotherapy [ Time Frame: 5 years ]
  9. Distribution of Age in adult patients with advanced Melanoma initiating nivolumab monotherapy [ Time Frame: 5 years ]
  10. Distribution of Gender in adult patients with advanced Melanoma initiating nivolumab/ipilimumab combination therapy [ Time Frame: 5 years ]
  11. Distribution of Height in adult patients with advanced Melanoma initiating nivolumab/ipilimumab combination therapy [ Time Frame: 5 years ]
  12. Distribution of Weight in adult patients with advanced Melanoma initiating nivolumab/ipilimumab combination therapy [ Time Frame: 5 years ]
  13. Distribution of Age in adult patients with advanced Melanoma initiating nivolumab/ipilimumab combination therapy [ Time Frame: 5 years ]
  14. Distribution of Initial Diagnosis of Melanoma in adult patients with advanced Melanoma initiating nivolumab monotherapy [ Time Frame: 5 years ]
  15. Distribution of Histological Subtypes in adult patients with advanced Melanoma initiating nivolumab monotherapy [ Time Frame: 5 years ]
  16. Distribution of Performance Status in adult patients with advanced Melanoma initiating nivolumab monotherapy [ Time Frame: 5 years ]
  17. Distribution of Comorbidities in adult patients with advanced Melanoma initiating nivolumab monotherapy [ Time Frame: 5 years ]
  18. Distribution of History of Cancer in adult patients with advanced Melanoma initiating nivolumab monotherapy [ Time Frame: 5 years ]
  19. Distribution of Initial Diagnosis of Melanoma in adult patients with advanced Melanoma initiating nivolumab/ipilimumab combination therapy [ Time Frame: 5 years ]
  20. Distribution of Histological Subtypes in adult patients with advanced Melanoma initiating nivolumab/ipilimumab combination therapy [ Time Frame: 5 years ]
  21. Distribution of Performance Status in adult patients with advanced Melanoma initiating nivolumab/ipilimumab combination therapy [ Time Frame: 5 years ]
  22. Distribution of Comorbidities in adult patients with advanced Melanoma initiating nivolumab/ipilimumab combination therapy [ Time Frame: 5 years ]
  23. Distribution of History of Cancer in adult patients with advanced Melanoma initiating nivolumab/ipilimumab combination therapy [ Time Frame: 5 years ]
  24. Composite of variation in treatment patterns in adult patients diagnosed with advanced melanoma [ Time Frame: 5 years ]
    overall dosing, regimen, indication, treatment, rationales, management and characteristics

  25. Distribution of incidence of Adverse Events (AEs) [ Time Frame: 5 years ]
  26. Distribution of severity of Adverse Events (AEs) [ Time Frame: 5 years ]
  27. Distribution of management of Adverse Events (AEs) [ Time Frame: 5 years ]
  28. European Organization for Research and Treatment of Cancer (EORTC) quality of life questionnaire (QLQ C-30) [ Time Frame: 5 years ]


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:   Probability Sample
Study Population
Data of patients will be collected who are treated in office-based practices and outpatients dept. of clinics across Germany
Criteria

Inclusion Criteria:

  • ≥ 18 years
  • advanced melanoma (Stage III/Stage IV)
  • histologically confirmed diagnosis
  • treatment decision for nivolumab mono- or combination therapy already taken
  • primary diagnosis of advanced melanoma after complete surgical tumor resection and no evidence of disease (cohort 3 only)

Exclusion Criteria:

  • current primary diagnosis of a cancer other than advanced melanoma, that requires systemic or other treatment
  • previous treatment with nivolumab, for nivolumab monotherapy cohort only
  • current active participation in an interventional clinical trial for treatment of advanced melanoma
  • Patients with a current diagnosis of persisting advanced melanoma or a cancer other than advanced melanoma that requires systemic or other treatment or has not been treated curatively (as per discretion of the investigator) (cohort 3 only)

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): NCT02990611


Contacts
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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 #.

Locations
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Germany
Local Institution Recruiting
Essen, Germany, 45147
Contact: Site 0001         
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: NCT02990611    
Other Study ID Numbers: CA209-654
First Posted: December 13, 2016    Key Record Dates
Last Update Posted: October 19, 2018
Last Verified: October 2018
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
Ipilimumab
Antineoplastic Agents, Immunological
Antineoplastic Agents