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Real-Life Effectiveness and Safety in Participants With Advanced/Metastatic Renal Cell Carcinoma Starting 1st Line Nivolumab and Ipilimumab Combination Therapy or Nivolumab Monotherapy After Prior Therapy

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ClinicalTrials.gov Identifier: NCT02940639
Recruitment Status : Recruiting
First Posted : October 21, 2016
Last Update Posted : February 23, 2021
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb

Study Description
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Brief Summary:
The purpose of this study is to estimate overall survival over a 5-year follow-up period among adult participants with advanced/metastatic kidney cancer, starting 1st line nivolumab and ipilimumab combination therapy or nivolumab monotherapy after prior therapy, in real-life conditions in Germany

Condition or disease
Renal Cell Carcinoma

Study Design
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Study Type : Observational
Estimated Enrollment : 490 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: A National, Prospective, Non-Interventional Study (NIS) in Patients With Advanced/Metastatic Renal Cell Carcinoma Starting 1st Line Nivolumab and Ipilimumab Combination Therapy or Nivolumab Monotherapy After Prior Therapy
Actual Study Start Date : October 27, 2016
Estimated Primary Completion Date : January 31, 2027
Estimated Study Completion Date : January 31, 2027

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort
Cohort 1
Participants with advanced/metastatic renal cell cancer (RCC) starting nivolumab monotherapy after prior therapy
Cohort 2
Participants with advanced/metastatic RCC starting 1st line therapy with nivolumab and ipilimumab combination therapy, in intermediate/poor risk participants


Outcome Measures
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Primary Outcome Measures :
  1. Overall Survival (OS) [ Time Frame: Approximately 5 years ]
    In participants with nivolumab and ipilimumab or nivolumab therapy


Secondary Outcome Measures :
  1. Overall Survival (OS) [ Time Frame: Approximately 5 years ]
    Separate by nivolumab and ipilimumab or nivolumab therapy, estimated overall lines of therapy, per line of therapy, per cohort, per index date (initial diagnosis vs start of therapy in the trial) and per subgroups of interest.

  2. Progression-Free Survival (PFS) [ Time Frame: Approximately 5 years ]
  3. Overall response rate (ORR) [ Time Frame: Approximately 5 years ]
  4. Best Overall Response (BOR) [ Time Frame: Approximately 5 years ]
  5. Best Overall Response Rate (BORR) [ Time Frame: Approximately 5 years ]
  6. Duration of Response [ Time Frame: Approximately 5 years ]
  7. Distribution of socio-demographic characteristics [ Time Frame: Approximately 5 years ]
    Socio-demographic characteristics (Gender, Height, Weight, Age) will be summarized using descriptive statistics.

  8. Distribution of clinical characteristics [ Time Frame: Approximately 5 years ]
    Clinical characteristics (Initial Diagnosis of RCC, Histological subtypes, Performance status, Comorbidities, history of cancer) will be summarized using descriptive statistics

  9. Distribution of Renal Cell Carcinoma (RCC) Treatment History [ Time Frame: At Baseline ]
  10. Distribution of Nivolumab Treatment Characteristics [ Time Frame: At initiation - index date, baseline ]
    Nivolumab monotherapy (cohort 1) or nivolumab and ipilimumab combination therapy (cohort 2)

  11. Distribution of Treatment Patterns [ Time Frame: Approximately 5 years ]
    Details on prior and evolution of current treatment patterns

  12. Incidence rate of Adverse Events (AEs), treatment-related AEs, select AEs and other immune-related AEs [ Time Frame: Approximately 5 years ]
  13. Distribution of Adverse Events (AE) characteristics [ Time Frame: Approximately 5 years ]
  14. Distribution of severity of Adverse Events (AEs) [ Time Frame: Approximately 5 years ]
  15. Distribution of management of Adverse Events (AEs) [ Time Frame: Approximately 5 years ]
  16. Quality of Life as assessed by Functional Assessment of Cancer Therapy - Kidney Symptom Index (FKSI-19) Questionnaire [ Time Frame: Approximately 5 years ]
  17. Utility as assessed by European Quality of Life-5 Dimensions (EQ-5D) Questionnaire [ Time Frame: Approximately 5 years ]

Eligibility Criteria
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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:   Probability Sample
Study Population
Adult participants who are at least 18 years of age at the time of the treatment decision with the diagnosis of advanced/metastatic RCC (histologically or cytologically confirmed) and whose physician has already decided to initiate a treatment with 1st line nivolumab and ipilimumab nivolumab combination therapy in intermediate/poor risk participants according to International Metastatic RCC Database Consortium (IMDC) score or with nivolumab monotherapy after prior therapy for the first time for the treatment of advanced/metastatic RCC, according to the label approved in Germany.
Criteria

Inclusion Criteria:

Adult participants, at least 18 years of age at time of treatment decision

  • Diagnosis of advanced/metastatic renal cell carcinoma (RCC) (confirmed by histology or cytology)
  • Treatment decision to initiate a treatment with nivolumab and ipilimumab or nivolumab for the first time for the treatment of advanced/metastatic RCC (according to the label approved in Germany) has already been taken
  • Signed informed consent

Exclusion Criteria:

  • Participants with a diagnosis of a cancer other than advanced/metastatic advanced RCC within the past five years, ie, a cancer other than advanced/metastatic RCC that requires systemic or other treatment. Participants that have been treated curatively more than five years ago with no evidence of recurrence and prostate cancer patients in active surveillance can be included.
  • Participants previously treated with nivolumab and/or ipilimumab
  • Participants currently included in an interventional clinical trial for their locally advanced or metastatic RCC. Participants 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.
Contacts and Locations
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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): NCT02940639


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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Germany
Local Institution Recruiting
Jena, Germany, 07743
Contact: Site 0001         
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
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Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
More Information
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Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT02940639    
Other Study ID Numbers: CA209-653
First Posted: October 21, 2016    Key Record Dates
Last Update Posted: February 23, 2021
Last Verified: February 2021
Additional relevant MeSH terms:
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Carcinoma
Carcinoma, Renal Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
 Kidney Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Kidney Diseases
Urologic Diseases