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Completed

NCT Number: NCT02990611

Observational Study of Nivolumab Monotherapy or in Combination With Ipilimumab in Participants With Advanced Melanoma and in Participants With Adjuvant Nivolumab Therapy

The purpose of this study is to describe the safety and effectiveness of nivolumab treatment, either in monotherapy or in combination with ipilimumab, overall and according to various subgroups of interest, in participants with advanced melanoma and in participants with adjuvant nivolumab therapy.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Local Institution - 0001

Essen, 45147, Germany

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

For Cohort 1 and 2: (Recruitment ended by 02/20/2020)

  • Advanced melanoma (Stage III/Stage IV)
  • Histologically confirmed diagnosis
  • Treatment decision for nivolumab monotherapy or nivolumab/ipilimumab combination therapy has already been taken

For Cohort 3: (Recruitment ended by 08/31/2020)

  • Primary diagnosis of advanced melanoma after complete surgical tumor resection and no evidence of disease
  • Treatment decision for adjuvant nivolumab therapy has already been taken

Exclusion criteria

For Cohort 1 and 2: (Recruitment ended by 02/20/2020)

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

For Cohort 3: (Recruitment ended by 08/31/2020)

  • 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)
  • Current active participation in an interventional clinical trial

Other protocol-defined inclusion/exclusion criteria apply

Treatment and study plan

Primary outcomes

  1. Overall survival (OS) of nivolumab/ipilimumab combination therapy

    Time frame: 5 years

  2. Relapse free survival (RFS) of adjuvant nivolumab therapy

    Time frame: 5 years

Secondary outcomes

  1. Overall survival (OS) of nivolumab monotherapy

    Time frame: 5 years

  2. Overall survival (OS) of nivolumab monotherapy or nivolumab/ipilimumab combination therapy, according to other subgroups of interest

    Time frame: 5 years

  3. Progression-free survival (PFS) of nivolumab monotherapy or nivolumab/ipilimumab combination therapy

    Time frame: 5 years

  4. Overall response rate (ORR) of nivolumab monotherapy or nivolumab/ipilimumab combination therapy

    Time frame: 5 years

  5. Best overall response (BOR) of nivolumab monotherapy and of nivolumab/ipilimumab combination therapy

    Time frame: 5 years

  6. Best overall response rate (BORR) of nivolumab monotherapy or nivolumab/ipilimumab combination therapy

    Time frame: 5 years

  7. Duration of response of monotherapy and combination therapy

    Time frame: Up to 5 years

  8. Distribution of sociodemographic characteristics: Age

    Time frame: 5 years

  9. Distribution of sociodemographic characteristics: Gender

    Time frame: 5 years

  10. Distribution of sociodemographic characteristics: BMI

    Time frame: 5 years

  11. Distribution of clinical characteristics: Initial diagnosis of melanoma

    Time frame: 5 years

  12. Distribution of clinical characteristics: Diagnosis of advanced melanoma

    Time frame: 5 years

  13. Distribution of clinical characteristics: Duration of disease from date of initial melanoma diagnosis to initial treatment in study, or date of study entry (if untreated)

    Time frame: 5 years

  14. Distribution of clinical characteristics: Surgery of complete tumor resection and no evidence of disease

    Time frame: 5 years

  15. Distribution of clinical characteristics: Clinical code and staging melanoma subtypes

    Time frame: 5 years

  16. Distribution of clinical characteristics: Comorbidities

    Time frame: 5 years

  17. Distribution of clinical characteristics: Diagnostic procedures

    Time frame: 5 years

  18. Distribution of clinical characteristics: Mutation status

    Time frame: 5 years

  19. Distribution of clinical characteristics: Performance status as measured by Eastern Cancer Oncology Group (ECOG) scale

    Time frame: 5 years

  20. Distribution of clinical characteristics: Medical history

    Time frame: 5 years

  21. Distribution of clinical characteristics: Concomitant medication

    Time frame: 5 years

  22. Distribution of clinical characteristics: History of cancer

    Time frame: 5 years

  23. Distribution of clinical characteristics: Previous enrollment in an interventional study randomized controlled trials (RCTS)

    Time frame: 5 years

  24. Distribution of treatment patterns: Type of treatment previously received

    Time frame: 5 years

  25. Distribution of treatment patterns: Stage of melanoma

    Time frame: 5 years

  26. Distribution of treatment patterns: Current treatment details

    Time frame: 5 years

  27. European Organization for Research and Treatment of Cancer (EORTC) quality of life questionnaire (QLQ C-30)

    Time frame: 5 years

  28. Incidence of adverse events (AEs)

    Time frame: 5 years

  29. Severity of adverse events (AEs)

    Time frame: 5 years

  30. Distribution of management of adverse events (AEs)

    Time frame: 5 years

  31. Overall survival (OS) of adjuvant therapy

    Time frame: 5 years

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study 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

Acronym: NICO

Important dates

Study start
2016
Primary completion
2025
Study completion
2025
First posted
Dec 13, 2016
Registry last updated
Jul 11, 2025

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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