NCT02940639Completed
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
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
Source: ClinicalTrials.gov · Last updated 11 Jul 2025
Brief summary (registry, in English)
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
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 499 (actual)
- First submitted
- 12 Oct 2016
- Start date
- 27 Oct 2016
- Primary completion date
- 3 Jun 2025
- Lead sponsor
- Bristol-Myers Squibb
- Diseases
- Kidney cancer
- NCT number
- NCT02940639
What you commit to
- Study type: Observational
- Participants enrolled: 499
- From 27 Oct 2016 to the primary completion date, 3 Jun 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
Other illness
- 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.
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| - Coordinator of this site? Confirm its status | Jena | Germany | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.