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

NCT02940639•Bristol-Myers Squibb

View on ClinicalTrials.gov

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

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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.

Locations (1)

Local Institution - 0001

Jena, Germany

Key Dates

Start Date

October 27, 2016

Primary Completion Date

June 3, 2025

Completion Date

June 3, 2025

Last Updated

July 11, 2025

Enrollment

499

ACTUAL participants

Conditions

Renal Cell Carcinoma

Association Between Galectin-3 Levels and Outcomes in Patients With Renal Cell Carcinoma, Transitional Cell Carcinoma , Non Small Cell Lung Cancer, and Hepatocellular Carcinoma, Treated With PD-1/PDL-1 Inhibitors

NCT07485114

Renal Cell Carcinoma (Kidney Cancer)Non Small Cell Lung Cancer+2 more

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RECRUITINGNA

Ketogenic Dietary Intervention to Improve Response to Immunotherapy in Patients With Metastatic Melanoma and Metastatic Kidney Cancer

NCT06391099

Clinical Stage IV Cutaneous Melanoma AJCC v8Metastatic Cutaneous Melanoma+2 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: July 11, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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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

Inclusion Criteria

Exclusion Criteria

Association Between Galectin-3 Levels and Outcomes in Patients With Renal Cell Carcinoma, Transitional Cell Carcinoma , Non Small Cell Lung Cancer, and Hepatocellular Carcinoma, Treated With PD-1/PDL-1 Inhibitors

Ketogenic Dietary Intervention to Improve Response to Immunotherapy in Patients With Metastatic Melanoma and Metastatic Kidney Cancer

Neoadjuvant of Axitinib Plus PD-1 to Improve Disease Free Survival of Patients With Renal Cell Carcinoma

A Clinical Study of Belzutifan and Zanzalintinib in People With Recurrent Kidney Cancer Following Adjuvant Therapy (MK-6482-033)

Immune Checkpoint Inhibitor Response in Solid Tumors Using a Live Tumor Diagnostic Platform

Open-Label Phase 1/2 Study of NEO-811 in Subjects With Locally Advanced or Metastatic Non-Resectable Clear Cell Renal Cell Carcinoma