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

Sponsor
Bristol-Myers Squibb (Industry)
Overall Status
Recruiting
CT.gov ID
NCT03455452
Collaborator
(none)
600
Enrollment
2
Locations
86.3
Anticipated Duration (Months)
300
Patients Per Site
3.5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    600 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official 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
    Actual Study Start Date :
    Jan 21, 2018
    Anticipated Primary Completion Date :
    Mar 31, 2025
    Anticipated Study Completion Date :
    Mar 31, 2025

    Arms and Interventions

    Arm Intervention/Treatment
    Cohort 1: Nivolumab

    Participants diagnosed with advanced renal cell carcinoma (RCC) and whose physician has decided to initiate a treatment with Nivolumab for the first time for the treatment of RCC
    Cohort 2: Nivolumab + Ipilimumab

    Participants diagnosed with advanced RCC and whose physician has decided to start a new systemic therapy with nivolumab + ipilimumab for the first time for the treatment of RCC

    Outcome Measures

    Primary Outcome Measures

    1. Overall Survival (OS) [Up to 3 years]

      By Cohort

    Secondary Outcome Measures

    1. Overall Survival (OS) [Up to 3 years]

    2. Progression Free Survival (PFS) [Up to 3 years]

    3. Overall Response Rate (ORR) [Up to 3 years]

    4. Best Overall Response Rate (BORR) [Up to 3 years]

    5. Best Overall Response (BOR) [Up to 3 years]

    6. Distribution of socio-demographic characteristics of participants [Approximately 3 years]

    7. Distribution of clinical characteristics of participants [Approximately 3 years]

    8. Distribution of management of participants with treatment-related adverse events (AEs) [Approximately 3 years]

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

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

    11. Distribution of treatment patterns in participants with advanced Renal Cell Carcinoma (RCC) [Approximately 3 years]

    12. Distribution of incidence of AEs [Approximately 3 years]

    13. Distribution of Severity of AEs [Approximately 3 years]

    14. Distribution of management of AEs [Approximately 3 years]

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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Local Institution Paris France 75002
    2 Local Institution Paris France 75002

    Sponsors and Collaborators

    • Bristol-Myers Squibb

    Investigators

    • Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Bristol-Myers Squibb
    ClinicalTrials.gov Identifier:
    NCT03455452
    Other Study ID Numbers:
    • CA209-9GY
    First Posted:
    Mar 6, 2018
    Last Update Posted:
    Feb 25, 2021
    Last Verified:
    Feb 1, 2021
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Carcinoma
    Adenocarcinoma
    Carcinoma, Renal Cell
    Kidney Neoplasms

    Study Results

    No Results Posted as of Feb 25, 2021