Carcinoma, Renal CellNCT05534789
Treatment Patterns and Clinical Outcomes Among Patients With Advanced Renal Cell Carcinoma (aRCC) Receiving Systemic First-line (1st Line) Anti-cancer Treatment Under Daily Routine in Germany: Retrospective Medical Chart Review (RENALISTIC Study).
An observational study of Carcinoma, Renal Cell, run by Pfizer at 1 site in United States.
Trial summary
The purpose of this study is to learn about the treatments used in for advanced renal cell carcinoma as well as effectiveness of these treatments in the real world. Study participants must be: At least 18 years of age or older. Confirmed renal cell carcinoma Received first line treatment Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Carcinoma, Renal Cell
- How many people
- 106 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Oct 2022to 13 Dec 2023
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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: Participants who received first line treatment for advanced renal call carcinoma
Who may be able to join
- Participants diagnosed with locally advanced or metastatic renal cell carcinoma
- Participants with full medical information is available regarding all treatments before, during and after 1st line
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Outcomes and Therapy Management Among Patients With Advanced Renal Cell Carcinoma (aRCC) Receiving Systemic First-line (1L) Anti-cancer Treatment Under Daily Routine in Germany: Retrospective Chart Review (RENALISTIC Study)
The purpose of this study is to learn about the treatments used in for advanced renal cell carcinoma as well as effectiveness of these treatments in the real world. Study participants must be:
At least 18 years of age or older. Confirmed renal cell carcinoma Received first line treatment
- Conditions
- Carcinoma, Renal Cell
- Keywords
- Real World Chart Review, Retrospective, Germany
- Medical subject headings
- Carcinoma, Renal Cell
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression Free Survival (PFS)
PFS was defined as time from treatment initiation of systemic 1-L therapy start date to documented date of tumor progression or date of death. Disease progression (PD) was defined as greater than equal to (>=) 20% increase in sum of diameters of the target lesions taking as reference the smallest sum on study (this included the baseline sum if that was the smallest on study) or unequivocal progression in non-target lesions or appearance of 1 or more new lesions. Analysis was performed by Kaplan-Meier method.
Measured: From treatment initiation date until PD, death or end of follow-up period whichever was earlier (maximum follow-up of 47.1 months)
PFS Rate at Month 6
PFS was defined as time from treatment initiation of systemic 1-L therapy start date to documented date of tumor progression or date of death. Disease progression (PD) was defined as greater than equal to (>=) 20% increase in sum of diameters of the target lesions taking as reference the smallest sum on study (this included the baseline sum if that was the smallest on study) or unequivocal progression in non-target lesions or appearance of 1 or more new lesions. PFS rate was percentage of participants with PFS.
Measured: 6 months post treatment initiation date (during maximum follow-up of 47.1 months)
PFS Rate at Month 9
PFS was defined as time from treatment initiation of systemic 1-L therapy start date to documented date of tumor progression or date of death. Disease progression (PD) was defined as greater than equal to (>=) 20% increase in sum of diameters of the target lesions taking as reference the smallest sum on study (this included the baseline sum if that was the smallest on study) or unequivocal progression in non-target lesions or appearance of 1 or more new lesions. PFS rate was percentage of participants with PFS.
Measured: 9 months post treatment initiation date (during maximum follow-up of 47.1 months)
PFS Rate at Month 12
PFS was defined as time from treatment initiation of systemic 1-L therapy start date to documented date of tumor progression or date of death. Disease progression (PD) was defined as greater than equal to (>=) 20% increase in sum of diameters of the target lesions taking as reference the smallest sum on study (this included the baseline sum if that was the smallest on study) or unequivocal progression in non-target lesions or appearance of 1 or more new lesions. PFS rate was percentage of participants with PFS.
Measured: 12 months post treatment initiation date (during maximum follow-up of 47.1 months)
PFS Rate at Month 18
PFS was defined as time from treatment initiation of systemic 1-L therapy start date to documented date of tumor progression or date of death. Disease progression (PD) was defined as greater than equal to (>=) 20% increase in sum of diameters of the target lesions taking as reference the smallest sum on study (this included the baseline sum if that was the smallest on study) or unequivocal progression in non-target lesions or appearance of 1 or more new lesions. PFS rate was percentage of participants with PFS.
Measured: 18 months post treatment initiation date (during maximum follow-up of 47.1 months)
Secondary outcomes (12)
Overall Survival (OS)
OS was defined as time from treatment initiation of systemic 1-L therapy to date of death due to any cause or last day of contact. Analysis was performed by Kaplan-Meier method.
Measured: From treatment initiation to death due to any cause or last day of contact, whichever occurred first (maximum follow-up of 47.1 months)
OS Rate at Months 12 and 18
OS was defined as time from treatment initiation of systemic 1-L therapy to date of death due to any cause or last day of contact. OS rate was measured as percentage of participants alive at specified time points.
Measured: 12- and 18-months post treatment initiation date (during maximum follow-up of 47.1 months)
Number of Participants According to Different Treatments Received
Number of participants were classified according to different drug groups prescribed: Immune checkpoint inhibitors + Tyrosine kinase inhibitor (ICI +TKI), ICI+ICI, TKI alone and ICI alone.
Measured: From treatment initiation to end of follow-up (maximum follow-up of 47.1 months)
Number of Participants With Different Drug Therapies
Number of participants were classified according to different drug regimen therapies prescribed: pembrolizumab + axitinib, nivolumab + ipilimumab, sunitinib, nivolumab, cabozantinib, tivozanib, pembrolizumab, pazopanib, axitinib and avelumab + axitinib.
Measured: From treatment initiation to end of follow-up (maximum follow-up of 47.1 months)
Best Overall Response
Best overall response was documented as the best response documented in the participant record. CR was defined as complete resolution of all visible disease as per the treating physician's opinion. PR was defined as partial reduction in size of visible disease in some or all areas without any areas of increase in visible disease. Disease progression (PD) was defined as greater than equal to (>=) 20% increase in sum of diameters of the target lesions taking as reference the smallest sum on study (this included the baseline sum if that was the smallest on study) or unequivocal progression in non-target lesions or appearance of 1 or more new lesions. Stable disease was defined as not qualifying for CR, PR, PD. In this outcome measure percentage of participants with best responses are recorded.
Measured: From treatment initiation until first documented PD or death or end of follow-up, whichever occurred first (maximum follow-up of 47.1 months)
Duration of Response (DOR)
DOR was defined as time from first disease response (CR/PR) to tumor progression among participants with a documented response and also had a documented date of response. CR was defined as complete resolution of all visible disease as per the treating physician's opinion. PR was defined as partial reduction in size of visible disease in some or all areas without any areas of increase in visible disease. Analysis was performed by Kaplan-Meier method.
Measured: From first disease response until tumor progression (maximum follow-up of 47.1 months)
Time to Progression (TTP)
TTP was defined as time from start of treatment of systemic 1 L therapy up to tumor progression without including deaths. Disease progression (PD) was defined as greater than equal to (>=) 20% increase in sum of diameters of the target lesions taking as reference the smallest sum on study (this included the baseline sum if that was the smallest on study) or unequivocal progression in non-target lesions or appearance of 1 or more new lesions. Analysis was performed by Kaplan-Meier method.
Measured: From treatment initiation until tumor progression or end of follow-up whichever occurred first (maximum follow-up of 47.1 months)
Time to Next Therapy (TTNT)
TTNT was defined as time from last systemic 1 L therapy administered up to start of next therapy among those participants who completed 1L therapy. Analysis was performed by Kaplan-Meier method.
Measured: From last systemic 1 L therapy to start of new therapy (maximum follow-up of 47.1 months)
Number of Participants With at Least 1 Dose Modification or Drug Discontinuation
A dose modification was defined as dose reduction of 1 or all drugs. Number of participants with dose modifications or with an interim/permanent discontinuation of one or all drugs of a therapy were reported in this outcome measure.
Measured: From treatment initiation to end of follow-up (maximum follow-up of 47.1 months)
Number of Participants Continuing Therapy After Dose Modification
A dose modification was defined as dose reduction of 1 or all drugs. Number of participants with dose modification of one or two drugs but continuing therapy were reported in this outcome measure.
Measured: From treatment initiation to end of follow-up (maximum follow-up of 47.1 months)
Number of Participants With Discontinuation of One or Two Drugs
Number of participants with discontinuation of one or two drugs were reported in this outcome measure.
Measured: From treatment initiation to end of follow-up (maximum follow-up of 47.1 months)
Number of Participants Continuing Therapy After Temporary/Permanent Discontinuation of Single Drugs
Number of participants continuing therapy after temporary/permanent discontinuation of single drugs are reported in this outcome measure.
Measured: From treatment initiation to end of follow-up (maximum follow-up of 47.1 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2022
- Study start15 Oct 2022
- Primary completion13 Dec 2023
- Study completion13 Dec 2023
Why it stopped: The trial prematurely terminated due to the inability to recruit the planned number of participants. The decision to terminate the trial was not based on any safety and/or efficacy concerns.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Carcinoma, Renal CellStudies 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
- 106 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
- NCT05534789
- Sponsor's protocol ID
- A4061099
- Status last verified
- Nov 2024
- First submitted
- 6 Sep 2022
- Last updated
- 20 Jan 2025
- Results posted
- Yes, on ClinicalTrials.gov
- 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 20 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Outcomes and Therapy Management Among Patients With Advanced Renal Cell Carcinoma (aRCC) Receiving Systemic First-line (1L) Anti-cancer Treatment Under Daily Routine in Germany: Retrospective Chart Review (RENALISTIC Study)
- ClinicalTrials.gov ID
- NCT05534789
- Acronym / sponsor ID
- A4061099
- Conditions
- Carcinoma, Renal Cell
- Keywords
- Real World Chart Review, Retrospective, Germany
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: The trial prematurely terminated due to the inability to recruit the planned number of participants. The decision to terminate the trial was not based on any safety and/or efficacy concerns.
- Enrolment
- 106 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- 15 Oct 2022 (actual)
- Primary completion
- 13 Dec 2023 (actual)
- Study completion
- 13 Dec 2023 (actual)
- First posted
- 10 Sep 2022 (actual)
- Results
- Posted 20 Jan 2025
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 treatments used in for advanced renal cell carcinoma as well as effectiveness of these treatments in the real world. Study participants must be:
At least 18 years of age or older. Confirmed renal cell carcinoma Received first line treatment
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants who received first line treatment for advanced renal call carcinoma
Key inclusion criteria (2 listed)
- Participants diagnosed with locally advanced or metastatic renal cell carcinoma
- Participants with full medical information is available regarding all treatments before, during and after 1st line
Key exclusion criteria (0 listed)
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
Progression Free Survival (PFS)
Time frame: From treatment initiation date until PD, death or end of follow-up period whichever was earlier (maximum follow-up of 47.1 months)
PFS was defined as time from treatment initiation of systemic 1-L therapy start date to documented date of tumor progression or date of death. Disease progression (PD) was defined as greater than equal to (>=) 20% increase in sum of diameters of the target lesions taking as reference the smallest sum on study (this included the baseline sum if that was the smallest on study) or unequivocal progression in non-target lesions or appearance of 1 or more new lesions. Analysis was performed by Kaplan-Meier method.
PFS Rate at Month 6
Time frame: 6 months post treatment initiation date (during maximum follow-up of 47.1 months)
PFS was defined as time from treatment initiation of systemic 1-L therapy start date to documented date of tumor progression or date of death. Disease progression (PD) was defined as greater than equal to (>=) 20% increase in sum of diameters of the target lesions taking as reference the smallest sum on study (this included the baseline sum if that was the smallest on study) or unequivocal progression in non-target lesions or appearance of 1 or more new lesions. PFS rate was percentage of participants with PFS.
PFS Rate at Month 9
Time frame: 9 months post treatment initiation date (during maximum follow-up of 47.1 months)
PFS was defined as time from treatment initiation of systemic 1-L therapy start date to documented date of tumor progression or date of death. Disease progression (PD) was defined as greater than equal to (>=) 20% increase in sum of diameters of the target lesions taking as reference the smallest sum on study (this included the baseline sum if that was the smallest on study) or unequivocal progression in non-target lesions or appearance of 1 or more new lesions. PFS rate was percentage of participants with PFS.
PFS Rate at Month 12
Time frame: 12 months post treatment initiation date (during maximum follow-up of 47.1 months)
PFS was defined as time from treatment initiation of systemic 1-L therapy start date to documented date of tumor progression or date of death. Disease progression (PD) was defined as greater than equal to (>=) 20% increase in sum of diameters of the target lesions taking as reference the smallest sum on study (this included the baseline sum if that was the smallest on study) or unequivocal progression in non-target lesions or appearance of 1 or more new lesions. PFS rate was percentage of participants with PFS.
PFS Rate at Month 18
Time frame: 18 months post treatment initiation date (during maximum follow-up of 47.1 months)
PFS was defined as time from treatment initiation of systemic 1-L therapy start date to documented date of tumor progression or date of death. Disease progression (PD) was defined as greater than equal to (>=) 20% increase in sum of diameters of the target lesions taking as reference the smallest sum on study (this included the baseline sum if that was the smallest on study) or unequivocal progression in non-target lesions or appearance of 1 or more new lesions. PFS rate was percentage of participants with PFS.
12 secondary outcomes
Overall Survival (OS)
Time frame: From treatment initiation to death due to any cause or last day of contact, whichever occurred first (maximum follow-up of 47.1 months)
OS Rate at Months 12 and 18
Time frame: 12- and 18-months post treatment initiation date (during maximum follow-up of 47.1 months)
Number of Participants According to Different Treatments Received
Time frame: From treatment initiation to end of follow-up (maximum follow-up of 47.1 months)
Number of Participants With Different Drug Therapies
Time frame: From treatment initiation to end of follow-up (maximum follow-up of 47.1 months)
Best Overall Response
Time frame: From treatment initiation until first documented PD or death or end of follow-up, whichever occurred first (maximum follow-up of 47.1 months)
Duration of Response (DOR)
Time frame: From first disease response until tumor progression (maximum follow-up of 47.1 months)
Time to Progression (TTP)
Time frame: From treatment initiation until tumor progression or end of follow-up whichever occurred first (maximum follow-up of 47.1 months)
Time to Next Therapy (TTNT)
Time frame: From last systemic 1 L therapy to start of new therapy (maximum follow-up of 47.1 months)
Number of Participants With at Least 1 Dose Modification or Drug Discontinuation
Time frame: From treatment initiation to end of follow-up (maximum follow-up of 47.1 months)
Number of Participants Continuing Therapy After Dose Modification
Time frame: From treatment initiation to end of follow-up (maximum follow-up of 47.1 months)
Number of Participants With Discontinuation of One or Two Drugs
Time frame: From treatment initiation to end of follow-up (maximum follow-up of 47.1 months)
Number of Participants Continuing Therapy After Temporary/Permanent Discontinuation of Single Drugs
Time frame: From treatment initiation to end of follow-up (maximum follow-up of 47.1 months)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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 Carcinoma, Renal Cell, 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 2 inclusion and 0 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: stopped early, as of the sponsor's last update on 20 Jan 2025. 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?
Yes. Results are posted in the registry (first posted 20 Jan 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Progression Free Survival (PFS) (time frame: From treatment initiation date until PD, death or end of follow-up period whichever was earlier (maximum follow-up of 47.1 months)). The study lists 5 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 20 Jan 2025.