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An Observational Study of Nivolumab in Participants With Advanced Kidney Cancer

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ClinicalTrials.gov Identifier: NCT03455452
Recruitment Status : Recruiting
First Posted : March 6, 2018
Last Update Posted : August 17, 2018
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 renal cell carcinoma, who start a new systemic therapy with nivolumab for the first time and within the market authorization approval, following a first or second-line therapy.

Condition or disease Intervention/treatment
Renal Cell Carcinoma Renal Cell Cancer Adenocarcinoma Of Kidney Adenocarcinoma, Renal Cell Kidney Cancer Cancer of the Kidney Other: Non-interventional

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Study Type : Observational
Estimated Enrollment : 323 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: A National, Prospective, Non-Interventional Study (NIS) of Nivolumab (BMS-936558) in Patients With Advanced Renal Cell Carcinoma in Second or Third Line Setting in Real Life
Actual Study Start Date : January 12, 2018
Estimated Primary Completion Date : January 18, 2022
Estimated Study Completion Date : January 18, 2022


Group/Cohort Intervention/treatment
Renal Cell Carcinoma (RCC) Participants
Participants diagnosed with advanced RCC and whose physician has decided to initiate a treatment with Nivolumab for the first time for the treatment of RCC
Other: Non-interventional
Non-interventional




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

Secondary Outcome Measures :
  1. Progression Free Survival (PFS) [ Time Frame: Up to 3 years ]
  2. Overall Response Rate (ORR) [ Time Frame: Up to 3 years ]
  3. Best Overall Response Rate (BORR) [ Time Frame: Up to 3 years ]
  4. Best Overall Response (BOR) [ Time Frame: Up to 3 years ]
  5. Distribution of socio-demographic characteristics in adult patients with advanced Renal Cell Carcinoma (RCC) [ Time Frame: Approximately 3 years ]
    Socio-demographic characteristics will be summarized using descriptive statistics

  6. Distribution of clinical characteristics in adult patients with advanced Renal Cell Carcinoma (RCC) [ Time Frame: Approximately 3 years ]
    Clinical characteristics will be summarized using descriptive statistics

  7. Distribution of treatment patterns in adult patients with advanced Renal Cell Carcinoma (RCC) [ Time Frame: Approximately 3 years ]
    Treatment patterns will be evaluated using descriptive statistics

  8. Distribution of management of treatment-related Adverse Events (AE) [ Time Frame: Approximately 3 years ]
  9. Memorial Sloan Kettering Cancer Center (MSKCC) score [ Time Frame: At baseline ]
    Questionnaire to determine overall survival based on clinical and laboratory data in metastatic RCC patients

  10. International Metastatic Renal Cell Carcinoma Database Consortium (IMDC) score [ Time Frame: At baseline ]
    Questionnaire to determine overall survival based on clinical and laboratory data in metastatic RCC patients

  11. Distribution of incidence of treatment-related Adverse Events (AE) [ Time Frame: Approximately 3 years ]
  12. Distribution of severity of treatment-related Adverse Events (AE) [ Time Frame: Approximately 3 years ]
  13. Quality of Life (QoL) scores (EQ-5D utility) [ 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)

  14. Quality of Life (QoL) scores (FKSI-19) [ 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")



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 patients who are at least 18 of age at the time of the treatment decision with the diagnosis of advanced RCC (histologically or cytologically confirmed) and whose physician has already decided to initiate a treatment with nivolumab for the first time for the treatment of RCC.
Criteria

Inclusion Criteria:

  • Adult patients with the diagnosis of advanced RCC (histologically or cytologically) whose physician has already decided to initiate a treatment with nivolumab as second or third line therapy for the first time for the treatment of RCC, according to the label approved in France

Exclusion Criteria:

  • Patients with a 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
  • Patients previously treated with anti-PD1, anti-PDL1 or anti-CTLA4 therapy
  • Patients currently included in an interventional clinical trial for their advanced or RCC. Patients 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

Other protocol defined inclusion/exclusion criteria could apply


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     History of Changes
Other Study ID Numbers: CA209-9GY
First Posted: March 6, 2018    Key Record Dates
Last Update Posted: August 17, 2018
Last Verified: August 2018

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Studies a U.S. FDA-regulated Drug Product: No
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
Nivolumab
Antineoplastic Agents, Immunological
Antineoplastic Agents