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

May 18, 2022 updated by: Bristol-Myers Squibb

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

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

Study Overview

Status

Active, not recruiting

Conditions

Study Type

Observational

Enrollment (Actual)

499

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Jena, Germany, 07743
        • Local Institution

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall Survival (OS)
Time Frame: Approximately 5 years
In participants with nivolumab and ipilimumab or nivolumab therapy
Approximately 5 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Approximately 5 years
Progression-Free Survival (PFS)
Time Frame: Approximately 5 years
Approximately 5 years
Overall response rate (ORR)
Time Frame: Approximately 5 years
Approximately 5 years
Best Overall Response (BOR)
Time Frame: Approximately 5 years
Approximately 5 years
Best Overall Response Rate (BORR)
Time Frame: Approximately 5 years
Approximately 5 years
Duration of Response
Time Frame: Approximately 5 years
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.
Approximately 5 years
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
Approximately 5 years
Distribution of Renal Cell Carcinoma (RCC) Treatment History
Time Frame: At Baseline
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)
At initiation - index date, baseline
Distribution of Treatment Patterns
Time Frame: Approximately 5 years
Details on prior and evolution of current treatment patterns
Approximately 5 years
Incidence rate of Adverse Events (AEs), treatment-related AEs, select AEs and other immune-related AEs
Time Frame: Approximately 5 years
Approximately 5 years
Distribution of Adverse Events (AE) characteristics
Time Frame: Approximately 5 years
Approximately 5 years
Distribution of severity of Adverse Events (AEs)
Time Frame: Approximately 5 years
Approximately 5 years
Distribution of management of Adverse Events (AEs)
Time Frame: Approximately 5 years
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
Approximately 5 years
Utility as assessed by European Quality of Life-5 Dimensions (EQ-5D) Questionnaire
Time Frame: Approximately 5 years
Approximately 5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bristol-Myers Squibb

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 27, 2016

Primary Completion (Anticipated)

December 15, 2025

Study Completion (Anticipated)

December 15, 2025

Study Registration Dates

First Submitted

October 12, 2016

First Submitted That Met QC Criteria

October 19, 2016

First Posted (Estimate)

October 21, 2016

Study Record Updates

Last Update Posted (Actual)

May 25, 2022

Last Update Submitted That Met QC Criteria

May 18, 2022

Last Verified

May 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CA209-653

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Renal Cell Carcinoma

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in South Africa

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe