NCT05534789

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).

Terminated Results posted Last updated 20 January 2025

What this trial tests

trial in Carcinoma, Renal Cell in 106 participants. Terminated before completion.

Timeline

15 October 2022

Primary endpoint
13 December 2023

13 December 2023

Quick facts

Lead sponsor	Pfizer
Status	Terminated
Study type	OBSERVATIONAL
Enrollment	106
Start date	15 October 2022
Primary completion	13 December 2023
Estimated completion	13 December 2023
Sites	1 location across United States

Conditions studied

• Carcinoma, Renal Cell — all drugs for Carcinoma, Renal Cell →

Sponsor

Pfizer — full company profile →

Who can join

18 and older, any sex, with Carcinoma, Renal Cell. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Progression Free Survival (PFS) Primary · 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.

Group	Value	95% CI
All Participants	9.4	0.7 – 46.7

PFS Rate at Month 6 Primary · 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.

Group	Value	95% CI
All Participants	64.4

PFS Rate at Month 9 Primary · 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.

Group	Value	95% CI
All Participants	52.9

PFS Rate at Month 12 Primary · 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.

Group	Value	95% CI
All Participants	41.3

PFS Rate at Month 18 Primary · 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.

Group	Value	95% CI
All Participants	29.8

Overall Survival (OS) Secondary · 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 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.

Group	Value	95% CI
All Participants	17.5	0.3 – 47.1

OS Rate at Months 12 and 18 Secondary · 12- and 18-months post treatment initiation date (during maximum follow-up of 47.1 months)

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.

Month 12

Group	Value	95% CI
All Participants	65.4

Month 18

Group	Value	95% CI
All Participants	49.0

Number of Participants According to Different Treatments Received Secondary · From treatment initiation to end of follow-up (maximum follow-up of 47.1 months)

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.

Group	Value	95% CI
All Participants	48
All Participants	21
All Participants	24
All Participants	11

Number of Participants With Different Drug Therapies Secondary · From treatment initiation to end of follow-up (maximum follow-up of 47.1 months)

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.

Group	Value	95% CI
All Participants	46
All Participants	21
All Participants	11
All Participants	8

Best Overall Response Secondary · From treatment initiation until first documented PD or death or end of follow-up, whichever occurred first (maximum follow-up of 47.1 months)

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 no

CR

Group	Value	95% CI
All Participants	5.8

PR

Group	Value	95% CI
All Participants	35.6

SD

Group	Value	95% CI
All Participants	5.8

PD

Group	Value	95% CI
All Participants	1.9

Not Evaluable

Group	Value	95% CI
All Participants	5.8

Not Applicable

Group	Value	95% CI
All Participants	45.2

Duration of Response (DOR) Secondary · From first disease response until tumor progression (maximum follow-up of 47.1 months)

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.

Group	Value	95% CI
All Participants	9.3	2.1 – 19.8

Time to Progression (TTP) Secondary · From treatment initiation until tumor progression or end of follow-up whichever occurred first (maximum follow-up of 47.1 months)

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.

Group	Value	95% CI
All Participants	9.7	0.7 – 46.7

Sponsor's own description

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

Publications & conference data

No peer-reviewed publications indexed yet for this trial.