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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03455452
Recruitment Status : Recruiting
First Posted : March 6, 2018
Last Update Posted : February 25, 2021
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb

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
Renal Cell Carcinoma Renal Cell Cancer Adenocarcinoma Of Kidney Adenocarcinoma, Renal Cell Kidney Cancer Cancer of the Kidney

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Study Type : Observational
Estimated 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 : January 21, 2018
Estimated Primary Completion Date : March 31, 2025
Estimated Study Completion Date : March 31, 2025


Group/Cohort
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



Primary Outcome Measures :
  1. Overall Survival (OS) [ Time Frame: Up to 3 years ]
    By Cohort


Secondary Outcome Measures :
  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)



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:   Non-Probability Sample
Study Population
Adult participants who are at least 18 of age at the time of the treatment decision with the diagnosis of advanced renal cell cancer (RCC) (histologically or cytologically confirmed) and whose physician has already decided to initiate a treatment with nivolumab or with nivolumab plus ipilimumab for the first time for the treatment of RCC, according to the label approved in France.
Criteria

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

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): NCT03455452


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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France
Local Institution Recruiting
Paris, France, 75002
Local Institution Recruiting
Paris, France, 75002
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: NCT03455452    
Other Study ID Numbers: CA209-9GY
First Posted: March 6, 2018    Key Record Dates
Last Update Posted: February 25, 2021
Last Verified: February 2021

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Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Carcinoma
Adenocarcinoma
Carcinoma, Renal Cell
Kidney Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Kidney Diseases
Urologic Diseases