Metastatic Renal Cell CarcinomaNCT05858749
A Study to Learn About the First and Later Lines of Medicines in Treating People With Metastatic Renal Cell Carcinoma (mRCC).
An observational study of Metastatic Renal Cell Carcinoma, run by Pfizer at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Renal Cell Carcinoma
- How many people
- 494 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Jun 2022to 30 Nov 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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)
Who cannot join
- There are no exclusion criteria for this study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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:
Read more
- 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.
- Conditions
- Metastatic Renal Cell Carcinoma
- Keywords
- Kidney cancer, Metastatic renal cell carcinoma (mRCC), International Metastatic Renal Cell Carcinoma Database Consortium (IMDC), Immunotherapy.
- Medical subject headings
- Carcinoma, Renal Cell, Kidney Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients with mRCC | Patients with mRCC in the IMDC |
What is being measured
The primary outcome is the main question the study is designed to answer.
Demographical characteristics
Gender Age at time of 1L initiation Race Region indicator (i.e., US vs. ex-US)
Measured: From Time of Initiation of First-line (1L) Immuno-oncology (IO) combination therapy to death (up to 60 months)
Date of mRCC diagnosis
Measured: From Time of Initiation of 1L IO combination therapy to death (up to 60 months)
Prior nephrectomy status
Measured: From Time of Initiation of 1L IO combination therapy to death (up to 60 months)
Date of nephrectomy (if applicable)
Measured: From Time of Initiation of 1L IO combination therapy to death (up to 60 months)
Tumor characteristics
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)
Measured: From Time of Initiation of 1L IO combination therapy to death (up to 60 months)
IMDC risk score
Assessed on index date and at initiation of each LOT
Measured: From Time of Initiation of 1L IO combination therapy to death (up to 60 months)
Number of lines of therapy received by each patient
Measured: From Time of Initiation of 1L IO combination therapy to death (up to 60 months)
Treatment agents received at each line of therapy
Measured: From Time of Initiation of 1L IO combination therapy to death (up to 60 months)
Duration of each line of therapy
Measured: 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
Measured: From Time of Initiation of 1L IO combination therapy to death (up to 60 months)
Reason for discontinuation for each line of therapy
Measured: From Time of Initiation of 1L IO combination therapy to death (up to 60 months)
Time to treatment discontinuation (TTD)
Defined as the time from treatment initiation to discontinuation of each therapy due to any reason including progression, death, or toxicity
Measured: From Time of Initiation of 1L IO combination therapy to death (up to 60 months)
Time to next treatment (TTNT)
Defined as time from the initiation of 1L treatment to initiation of subsequent therapy or death
Measured: From Time of Initiation of 1L IO combination therapy to death (up to 60 months)
Physician-assessed best response
Overall best response rate (complete or partial) Stable disease Progressive disease
Measured: From Time of Initiation of 1L IO combination therapy to death (up to 60 months)
Overall survival
Defined as the time between initiation of 1L IO combination therapy to death
Measured: From Time of Initiation of 1L IO combination therapy to death (up to 60 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2023
- Study start20 Jun 2022
- Primary completion30 Nov 2022
- Study completion30 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Renal Cell CarcinomaStudies of the same condition, open and under way.
- More trials run by PfizerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 494 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05858749
- Sponsor's protocol ID
- A4061100
- Status last verified
- Jun 2026
- First submitted
- 18 Apr 2023
- Last updated
- 15 Jun 2026
- Results posted
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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)
- ClinicalTrials.gov ID
- NCT05858749
- Acronym / sponsor ID
- A4061100
- Conditions
- Metastatic Renal Cell Carcinoma
- Keywords
- Kidney cancer, Metastatic renal cell carcinoma (mRCC), International Metastatic Renal Cell Carcinoma Database Consortium (IMDC), Immunotherapy.
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 494 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- 20 Jun 2022 (actual)
- Primary completion
- 30 Nov 2022 (actual)
- Study completion
- 30 Nov 2022 (actual)
- First posted
- 15 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with mRCC | – | –Patients with mRCC in the IMDC |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (1 listed)
- There are no exclusion criteria for this study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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)
Date of mRCC diagnosis
Time frame: 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)
Date of nephrectomy (if applicable)
Time frame: 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)
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
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)
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)
Duration of each line of therapy
Time frame: 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)
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)
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
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
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2026.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pfizer CT.gov Call Center study director
Pfizer
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Metastatic Renal Cell Carcinoma, run by Pfizer at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Demographical characteristics (time frame: From Time of Initiation of First-line (1L) Immuno-oncology (IO) combination therapy to death (up to 60 months)). The study lists 15 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jun 2026.