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
![]() |
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. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT02940639 |
Recruitment Status :
Active, not recruiting
First Posted : October 21, 2016
Last Update Posted : May 25, 2022
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease |
---|
Renal Cell Carcinoma |
Study Type : | Observational |
Actual Enrollment : | 499 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 : | December 15, 2025 |
Estimated Study Completion Date : | December 15, 2025 |

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
|
- Overall Survival (OS) [ Time Frame: Approximately 5 years ]In participants with nivolumab and ipilimumab or nivolumab therapy
- 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.
- Progression-Free Survival (PFS) [ Time Frame: Approximately 5 years ]
- Overall response rate (ORR) [ Time Frame: Approximately 5 years ]
- Best Overall Response (BOR) [ Time Frame: Approximately 5 years ]
- Best Overall Response Rate (BORR) [ Time Frame: Approximately 5 years ]
- Duration of Response [ Time Frame: Approximately 5 years ]
- Distribution of socio-demographic characteristics [ Time Frame: Approximately 5 years ]Socio-demographic characteristics (Gender, Height, Weight, Age) will be summarized using descriptive statistics.
- 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
- Distribution of Renal Cell Carcinoma (RCC) Treatment History [ Time Frame: At Baseline ]
- Distribution of Nivolumab Treatment Characteristics [ Time Frame: At initiation - index date, baseline ]Nivolumab monotherapy (cohort 1) or nivolumab and ipilimumab combination therapy (cohort 2)
- Distribution of Treatment Patterns [ Time Frame: Approximately 5 years ]Details on prior and evolution of current treatment patterns
- Incidence rate of Adverse Events (AEs), treatment-related AEs, select AEs and other immune-related AEs [ Time Frame: Approximately 5 years ]
- Distribution of Adverse Events (AE) characteristics [ Time Frame: Approximately 5 years ]
- Distribution of severity of Adverse Events (AEs) [ Time Frame: Approximately 5 years ]
- Distribution of management of Adverse Events (AEs) [ Time Frame: Approximately 5 years ]
- Quality of Life as assessed by Functional Assessment of Cancer Therapy - Kidney Symptom Index (FKSI-19) Questionnaire [ Time Frame: Approximately 5 years ]
- Utility as assessed by European Quality of Life-5 Dimensions (EQ-5D) Questionnaire [ Time Frame: Approximately 5 years ]

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Probability Sample |
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.

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
Germany | |
Local Institution | |
Jena, Germany, 07743 |
Study Director: | Bristol-Myers Squibb | Bristol-Myers Squibb |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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: | May 25, 2022 |
Last Verified: | May 2022 |
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 |