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Completed

NCT Number: NCT02940639

Real-Life Effectiveness and Safety in Participants With Advanced/Metastatic Renal Cell Carcinoma Starting 1st Line Nivolumab and Ipilimumab Combination Therapy or Nivolumab Monotherapy After Prior Therapy

The purpose of this study is to estimate overall survival over a 5-year follow-up period among adult participants with advanced/metastatic kidney cancer, starting 1st line nivolumab and ipilimumab combination therapy or nivolumab monotherapy after prior therapy, in real-life conditions in Germany

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Key information

Conditions

Renal Cell Carcinoma Adenocarcinoma Carcinoma Carcinoma, Renal Cell Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Kidney Neoplasms Male Urogenital Diseases Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Urogenital Diseases Urogenital Neoplasms Urologic Diseases Urologic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Local Institution - 0001

Jena, 07743, Germany

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

Adult participants, at least 18 years of age at time of treatment decision

  • Diagnosis of advanced/metastatic renal cell carcinoma (RCC) (confirmed by histology or cytology)
  • Treatment decision to initiate a treatment with nivolumab and ipilimumab or nivolumab for the first time for the treatment of advanced/metastatic RCC (according to the label approved in Germany) has already been taken
  • Signed informed consent

Exclusion criteria

  • Participants with a diagnosis of a cancer other than advanced/metastatic advanced RCC within the past five years, ie, a cancer other than advanced/metastatic RCC that requires systemic or other treatment. Participants that have been treated curatively more than five years ago with no evidence of recurrence and prostate cancer patients in active surveillance can be included.
  • Participants previously treated with nivolumab and/or ipilimumab
  • Participants currently included in an interventional clinical trial for their locally advanced or metastatic RCC. Participants who have completed their participation in an interventional trial; or who are not receiving study drug anymore and who are only followed-up for OS can be enrolled.

Treatment and study plan

Primary outcomes

  1. Overall Survival (OS)

    Time frame: Approximately 5 years

    In participants with nivolumab and ipilimumab or nivolumab therapy

Secondary outcomes

  1. Overall Survival (OS)

    Time frame: Approximately 5 years

    Separate by nivolumab and ipilimumab or nivolumab therapy, estimated overall lines of therapy, per line of therapy, per cohort, per index date (initial diagnosis vs start of therapy in the trial) and per subgroups of interest.

  2. Progression-Free Survival (PFS)

    Time frame: Approximately 5 years

  3. Overall response rate (ORR)

    Time frame: Approximately 5 years

  4. Best Overall Response (BOR)

    Time frame: Approximately 5 years

  5. Best Overall Response Rate (BORR)

    Time frame: Approximately 5 years

  6. Duration of Response

    Time frame: Approximately 5 years

  7. Distribution of socio-demographic characteristics

    Time frame: Approximately 5 years

    Socio-demographic characteristics (Gender, Height, Weight, Age) will be summarized using descriptive statistics.

  8. Distribution of clinical characteristics

    Time frame: Approximately 5 years

    Clinical characteristics (Initial Diagnosis of RCC, Histological subtypes, Performance status, Comorbidities, history of cancer) will be summarized using descriptive statistics

  9. Distribution of Renal Cell Carcinoma (RCC) Treatment History

    Time frame: At Baseline

  10. Distribution of Nivolumab Treatment Characteristics

    Time frame: At initiation - index date, baseline

    Nivolumab monotherapy (cohort 1) or nivolumab and ipilimumab combination therapy (cohort 2)

  11. Distribution of Treatment Patterns

    Time frame: Approximately 5 years

    Details on prior and evolution of current treatment patterns

  12. Incidence rate of Adverse Events (AEs), treatment-related AEs, select AEs and other immune-related AEs

    Time frame: Approximately 5 years

  13. Distribution of Adverse Events (AE) characteristics

    Time frame: Approximately 5 years

  14. Distribution of severity of Adverse Events (AEs)

    Time frame: Approximately 5 years

  15. Distribution of management of Adverse Events (AEs)

    Time frame: Approximately 5 years

  16. Quality of Life as assessed by Functional Assessment of Cancer Therapy - Kidney Symptom Index (FKSI-19) Questionnaire

    Time frame: Approximately 5 years

  17. Utility as assessed by European Quality of Life-5 Dimensions (EQ-5D) Questionnaire

    Time frame: Approximately 5 years

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study title

A National, Prospective, Non-Interventional Study (NIS) in Patients With Advanced/Metastatic Renal Cell Carcinoma Starting 1st Line Nivolumab and Ipilimumab Combination Therapy or Nivolumab Monotherapy After Prior Therapy

Important dates

Study start
2016
Primary completion
2025
Study completion
2025
First posted
Oct 21, 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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