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Completed

NCT Number: NCT03455452

Non-Interventional Study (NIS) of Nivolumab With or Without Ipilimumab in Participants With Advanced Kidney Cancer

This is a French, nationwide, prospective, observational, multi-center study in participants diagnosed with advanced renal cell carcinoma, who start a new systemic therapy with nivolumab with or without ipilimumab for the first time and within the market authorization approval.

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Key information

Conditions

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

Paris, 75002, France

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

-Adult participants with the diagnosis of advanced renal cell cancer (RCC) (histologically or cytologically) whose physician has already decided to initiate a treatment with nivolumab with or without ipilimumab for the first time for the treatment of RCC, according to the label approved in France

NOTE: Nivolumab with ipilimumab is indicated for the first-line treatment of adult participants with intermediate/poor-risk advanced RCC

Exclusion criteria

  • Primary diagnosis of a cancer other than advanced RCC within the past five years, ie, a cancer other than RCC that requires systemic or other treatment
  • Previously treated with anti-PD1, anti-programmed death-ligand 1 (anti-PDL1) or anti-CTLA4 therapy
  • Currently included in an interventional clinical trial for advanced or RCC. Participants who have completed participation in an interventional trial; or who are not receiving study drug anymore and who are only followed-up for overall survival (OS) can be enrolled
  • Pregnant women and participants under guardianship

Treatment and study plan

Primary outcomes

  1. Overall Survival (OS)

    Time frame: Up to 3 years

    By Cohort

Secondary outcomes

  1. Overall Survival (OS)

    Time frame: Up to 3 years

  2. Progression Free Survival (PFS)

    Time frame: Up to 3 years

  3. Overall Response Rate (ORR)

    Time frame: Up to 3 years

  4. Best Overall Response Rate (BORR)

    Time frame: Up to 3 years

  5. Best Overall Response (BOR)

    Time frame: Up to 3 years

  6. Distribution of socio-demographic characteristics of participants

    Time frame: Approximately 3 years

  7. Distribution of clinical characteristics of participants

    Time frame: Approximately 3 years

  8. Distribution of management of participants with treatment-related adverse events (AEs)

    Time frame: Approximately 3 years

  9. Distribution of management of participants according to Memorial Sloan Kettering Cancer Center (MSKCC) score

    Time frame: At baseline

  10. Distribution of management of participants according to International Metastatic Renal Cell Carcinoma Database Consortium (IMDC) score

    Time frame: At baseline

  11. Distribution of treatment patterns in participants with advanced Renal Cell Carcinoma (RCC)

    Time frame: Approximately 3 years

  12. Distribution of incidence of AEs

    Time frame: Approximately 3 years

  13. Distribution of Severity of AEs

    Time frame: Approximately 3 years

  14. Distribution of management of AEs

    Time frame: Approximately 3 years

  15. Health-related quality of life of participants using Functional Assessment of Cancer Therapy -Kidney Symptom Index (FKSI-19) questionnaires

    Time frame: Approximately 3 years

    The FKSI-19 will be graded by the patient on a scale from 0 to 4 (range "not at all to very much")

  16. Health-related quality of life of participants using European Quality of Life-5 Dimensions (EQ-5D) questionnaires

    Time frame: Approximately 3 years

    The EQ-5D descriptive system consists of 5 dimensions: Mobility, Self-Care, Usual Activities, Pain/Discomfort, and Anxiety/Depression, each with 3 levels (eg, no problems, moderate problems, extreme problems)

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) With or Without Ipilimumab (BMS-734016) in Patients With Advanced Renal Cell Carcinoma in Real Life Setting

Acronym: WITNESS

Important dates

Study start
2018
Primary completion
2025
Study completion
2025
First posted
Mar 6, 2018
Registry last updated
Jun 16, 2026

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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