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

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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

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

Intervention:

  • Other: Non-interventional

Purpose: 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.

Study Type: Observational

Clinical Trials Identifier NCT 8-digits: NCT03455452

Sponsor: Bristol-Myers Squibb

Primary Outcome Measures:

  • Measure: Overall Survival (OS)
  • Time Frame: up to 3 years
  • Safety Issue:

Secondary Outcome Measures:

  • Measure: Progression Free Survival (PFS)
  • Time Frame: Up to 3 years
  • Safety Issue:
  • Measure: Overall Response Rate (ORR)
  • Time Frame: Up to 3 years
  • Safety Issue:
  • Measure: Best Overall Response Rate (BORR)
  • Time Frame: Up to 3 years
  • Safety Issue:
  • Measure: Best Overall Response (BOR)
  • Time Frame: Up to 3 years
  • Safety Issue:
  • Measure: Distribution of socio-demographic characteristics in adult patients with advanced Renal Cell Carcinoma (RCC)
  • Time Frame: Approximately 3 years
  • Safety Issue:
  • Measure: Distribution of clinical characteristics in adult patients with advanced Renal Cell Carcinoma (RCC)
  • Time Frame: Approximately 3 years
  • Safety Issue:
  • Measure: Distribution of treatment patterns in adult patients with advanced Renal Cell Carcinoma (RCC)
  • Time Frame: Approximately 3 years
  • Safety Issue:
  • Measure: Distribution of management of treatment-related Adverse Events (AE)
  • Time Frame: Approximately 3 years
  • Safety Issue:
  • Measure: Memorial Sloan Kettering Cancer Center (MSKCC) score
  • Time Frame: At baseline
  • Safety Issue:
  • Measure: International Metastatic Renal Cell Carcinoma Database Consortium (IMDC) score
  • Time Frame: At baseline
  • Safety Issue:
  • Measure: Distribution of incidence of treatment-related Adverse Events (AE)
  • Time Frame: Approximately 3 years
  • Safety Issue:
  • Measure: Distribution of severity of treatment-related Adverse Events (AE)
  • Time Frame: Approximately 3 years
  • Safety Issue:
  • Measure: Quality of Life (QoL) scores (EQ-5D utility)
  • Time Frame: Approximately 3 years
  • Safety Issue:
  • Measure: Quality of Life (QoL) scores (FKSI-19)
  • Time Frame: Approximately 3 years
  • Safety Issue:

Estimated Enrollment: 323

Study Start Date: January 12, 2018

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Eligibility:

  • Age: minimum 18 Years maximum N/A
  • Gender: All

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:

  • 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

Contact:

  • Recruiting sites have contact information. Please contact the sites directly. If there is no contact information,
  • please email:

Locations:

  • Local Institution
  • Paris 75002 France
  • Local Institution
  • Paris 75002 France

View trial on ClinicalTrials.gov

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