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

Sponsor

Pfizer (Industry)

Overall Status

Completed

CT.gov ID

NCT05858749

Collaborator

(none)

494

Enrollment

Location

5.4

Actual Duration (Months)

92.2

Patients Per Site Per Month

Study Details

Study Description

Brief 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 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.

Condition or Disease	Intervention/Treatment	Phase
Metastatic Renal Cell Carcinoma

Study Design

Study Type:

Observational

Actual Enrollment :

494 participants

Observational Model:

Cohort

Time Perspective:

Retrospective

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)

Actual Study Start Date :

Jun 20, 2022

Actual Primary Completion Date :

Nov 30, 2022

Actual Study Completion Date :

Nov 30, 2022

Arms and Interventions

Arm	Intervention/Treatment
Patients with mRCC Patients with mRCC in the IMDC

Outcome Measures

Primary Outcome Measures

Demographical characteristics [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 [From Time of Initiation of 1L IO combination therapy to death (up to 60 months)]
Prior nephrectomy status [From Time of Initiation of 1L IO combination therapy to death (up to 60 months)]
Date of nephrectomy (if applicable) [From Time of Initiation of 1L IO combination therapy to death (up to 60 months)]
Tumor characteristics [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 [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 [From Time of Initiation of 1L IO combination therapy to death (up to 60 months)]
Treatment agents received at each line of therapy [From Time of Initiation of 1L IO combination therapy to death (up to 60 months)]
Duration of each line of therapy [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 [From Time of Initiation of 1L IO combination therapy to death (up to 60 months)]
Reason for discontinuation for each line of therapy [From Time of Initiation of 1L IO combination therapy to death (up to 60 months)]
Time to treatment discontinuation (TTD) [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) [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 [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 [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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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)