A Study to Learn About the First and Later Lines of Medicines in Treating People With Metastatic Renal Cell Carcinoma (mRCC).

June 11, 2026 updated by: Pfizer

Clinical Effectiveness of First-Line Immuno-oncology (IO) Combination Treatment and Subsequent Lines of Therapy in Patients With Metastatic Renal Cell Carcinoma (mRCC) in the International Metastatic Renal Cell Carcinoma Database Consortium (IMDC)

The purpose of this study is to learn about the effectiveness of the first and later lines of medicines on clinical outcomes in people with mRCC.

The study includes participants who:

  • are 18 years old or above and have mRCC
  • took medicines that use the bodies immunity to fight against cancer as their first choice of treatment
  • took other medicines after taking the above first choice of treatment

This is a study that looks into the data collected through a particular database from selected academic clinical sites participating in this study. The data of interest include:

  • the length of time between the start of a patient's treatment and the end of treatment
  • the length of time between the start of treatment and death
  • physician assessment of a patient's response to treatment

We will compare the experiences of people receiving different combinations of treatments and see if there are any differences in the effectiveness of these medicines.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

494

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

  • United States
    • New York
      • New York, New York, United States, 10017
        • Pfizer Headquarters

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

This is a retrospective, longitudinal cohort study that involves the analysis of data collected through the IMDC database from selected academic clinical sites participating in this study.

Description

Inclusion Criteria:

  • Diagnosed with mRCC
  • Age 18 years or over at the time of mRCC diagnosis
  • Received IO combination treatment in 1L such as receiving ipilimumab + nivolumab or an axitinib-based regimen (ie, axitinib + pembrolizumab or axitinib + avelumab) as 1L
  • Received subsequent treatments following 1L (e.g., 2L, 3L)
  • Actively treated at an IMDC clinical center (to avoid incomplete data)

Exclusion Criteria:

- There are no exclusion criteria for this study

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

Cohorts and Interventions

Group / Cohort
Patients with mRCC
Patients with mRCC in the IMDC

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Demographical characteristics
Time Frame: From Time of Initiation of First-line (1L) Immuno-oncology (IO) combination therapy to death (up to 60 months)
Gender Age at time of 1L initiation Race Region indicator (i.e., US vs. ex-US)
From Time of Initiation of First-line (1L) Immuno-oncology (IO) combination therapy to death (up to 60 months)
Date of mRCC diagnosis
Time Frame: From Time of Initiation of 1L IO combination therapy to death (up to 60 months)
From Time of Initiation of 1L IO combination therapy to death (up to 60 months)
Prior nephrectomy status
Time Frame: From Time of Initiation of 1L IO combination therapy to death (up to 60 months)
From Time of Initiation of 1L IO combination therapy to death (up to 60 months)
Date of nephrectomy (if applicable)
Time Frame: From Time of Initiation of 1L IO combination therapy to death (up to 60 months)
From Time of Initiation of 1L IO combination therapy to death (up to 60 months)
Tumor characteristics
Time Frame: From Time of Initiation of 1L IO combination therapy to death (up to 60 months)
Histology type (i.e., clear cell vs. non-clear cell RCC) Number of metastatic sites (e.g., 1 site or more than 1 site) Site of metastases (e.g., brain, bone, lung)
From Time of Initiation of 1L IO combination therapy to death (up to 60 months)
IMDC risk score
Time Frame: From Time of Initiation of 1L IO combination therapy to death (up to 60 months)
Assessed on index date and at initiation of each LOT
From Time of Initiation of 1L IO combination therapy to death (up to 60 months)
Number of lines of therapy received by each patient
Time Frame: From Time of Initiation of 1L IO combination therapy to death (up to 60 months)
From Time of Initiation of 1L IO combination therapy to death (up to 60 months)
Treatment agents received at each line of therapy
Time Frame: From Time of Initiation of 1L IO combination therapy to death (up to 60 months)
From Time of Initiation of 1L IO combination therapy to death (up to 60 months)
Duration of each line of therapy
Time Frame: From Time of Initiation of 1L IO combination therapy to death (up to 60 months)
From Time of Initiation of 1L IO combination therapy to death (up to 60 months)
Time from discontinuation of previous line of therapy to initiation of subsequent line of therapy
Time Frame: From Time of Initiation of 1L IO combination therapy to death (up to 60 months)
From Time of Initiation of 1L IO combination therapy to death (up to 60 months)
Reason for discontinuation for each line of therapy
Time Frame: From Time of Initiation of 1L IO combination therapy to death (up to 60 months)
From Time of Initiation of 1L IO combination therapy to death (up to 60 months)
Time to treatment discontinuation (TTD)
Time Frame: From Time of Initiation of 1L IO combination therapy to death (up to 60 months)
Defined as the time from treatment initiation to discontinuation of each therapy due to any reason including progression, death, or toxicity
From Time of Initiation of 1L IO combination therapy to death (up to 60 months)
Time to next treatment (TTNT)
Time Frame: From Time of Initiation of 1L IO combination therapy to death (up to 60 months)
Defined as time from the initiation of 1L treatment to initiation of subsequent therapy or death
From Time of Initiation of 1L IO combination therapy to death (up to 60 months)
Physician-assessed best response
Time Frame: From Time of Initiation of 1L IO combination therapy to death (up to 60 months)
Overall best response rate (complete or partial) Stable disease Progressive disease
From Time of Initiation of 1L IO combination therapy to death (up to 60 months)
Overall survival
Time Frame: From Time of Initiation of 1L IO combination therapy to death (up to 60 months)
Defined as the time between initiation of 1L IO combination therapy to death
From Time of Initiation of 1L IO combination therapy to death (up to 60 months)

Collaborators and Investigators

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

Sponsor

Pfizer

Investigators

  • Study Director: Pfizer CT.gov Call Center, Pfizer

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.

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)

June 20, 2022

Primary Completion (Actual)

November 30, 2022

Study Completion (Actual)

November 30, 2022

Study Registration Dates

First Submitted

April 18, 2023

First Submitted That Met QC Criteria

May 12, 2023

First Posted (Actual)

May 15, 2023

Study Record Updates

Last Update Posted (Actual)

June 15, 2026

Last Update Submitted That Met QC Criteria

June 11, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A4061100

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

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.

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