Working…
Help guide our efforts to modernize ClinicalTrials.gov.
Send us your comments by March 14, 2020.
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 3 for:    Renal Cancer | 936558 | France
Previous Study | Return to List | Next Study

An Observational Study of Nivolumab in Participants With Advanced Kidney Cancer

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 : August 17, 2018
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb

Tracking Information
First Submitted Date February 21, 2018
First Posted Date March 6, 2018
Last Update Posted Date August 17, 2018
Actual Study Start Date January 12, 2018
Estimated Primary Completion Date January 18, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: February 28, 2018)
Overall Survival (OS) [ Time Frame: up to 3 years ]
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT03455452 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: August 16, 2018)
  • Progression Free Survival (PFS) [ Time Frame: Up to 3 years ]
  • Overall Response Rate (ORR) [ Time Frame: Up to 3 years ]
  • Best Overall Response Rate (BORR) [ Time Frame: Up to 3 years ]
  • Best Overall Response (BOR) [ Time Frame: Up to 3 years ]
  • 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
  • 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
  • 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
  • Distribution of management of treatment-related Adverse Events (AE) [ Time Frame: Approximately 3 years ]
  • 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
  • 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
  • Distribution of incidence of treatment-related Adverse Events (AE) [ Time Frame: Approximately 3 years ]
  • Distribution of severity of treatment-related Adverse Events (AE) [ Time Frame: Approximately 3 years ]
  • 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)
  • 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")
Original Secondary Outcome Measures
 (submitted: February 28, 2018)
  • Progression Free Survival (PFS) [ Time Frame: Up to 3 years ]
  • Overall Response Rate (ORR) [ Time Frame: Up to 3 years ]
  • Best Overall Response Rate (BORR) [ Time Frame: Up to 3 years ]
  • Best Overall Response (BOR) [ Time Frame: Up to 3 years ]
  • 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
  • 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
  • Distribution of treatment patterns [ Time Frame: Approximately 3 years ]
    Details on prior and evolution of current treatment patterns
  • Distribution of management of treatment-related Adverse Events (AE) [ Time Frame: Approximately 3 years ]
  • 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
  • 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
  • Distribution of incidence of treatment-related Adverse Events (AE) [ Time Frame: Approximately 3 years ]
  • Distribution of severity of treatment-related Adverse Events (AE) [ Time Frame: Approximately 3 years ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title An Observational Study of Nivolumab in Participants With Advanced Kidney Cancer
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
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.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition
  • Renal Cell Carcinoma
  • Renal Cell Cancer
  • Adenocarcinoma Of Kidney
  • Adenocarcinoma, Renal Cell
  • Kidney Cancer
  • Cancer of the Kidney
Intervention Other: Non-interventional
Non-interventional
Study Groups/Cohorts 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
Intervention: Other: Non-interventional
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: February 28, 2018)
323
Original Estimated Enrollment Same as current
Estimated Study Completion Date January 18, 2022
Estimated Primary Completion Date January 18, 2022   (Final data collection date for primary outcome measure)
Eligibility 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

Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
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 #.
Listed Location Countries France
Removed Location Countries  
 
Administrative Information
NCT Number NCT03455452
Other Study ID Numbers CA209-9GY
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Responsible Party Bristol-Myers Squibb
Study Sponsor Bristol-Myers Squibb
Collaborators Not Provided
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
PRS Account Bristol-Myers Squibb
Verification Date August 2018