Clinical trial NCT05858749: A Study to Learn About the First and Later Lines of Medicines in Treating People With Metastatic Renal Cell Carcinoma (mRCC).
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)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Metastatic Renal Cell Carcinoma
Keywords: Kidney cancer
Metastatic renal cell carcinoma (mRCC)
International Metastatic Renal Cell Carcinoma Database Consortium (IMDC)
Immunotherapy.
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2023-05-15
Enrollment: 494
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
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.

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.


Eligibility criteria: 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

Primary outcomes:
measure: Demographical characteristics
timeFrame: From Time of Initiation of First-line (1L) Immuno-oncology (IO) combination therapy to death (up to 60 months)
measure: Date of mRCC diagnosis
timeFrame: From Time of Initiation of 1L IO combination therapy to death (up to 60 months)
measure: Prior nephrectomy status
timeFrame: From Time of Initiation of 1L IO combination therapy to death (up to 60 months)
measure: Date of nephrectomy (if applicable)
timeFrame: From Time of Initiation of 1L IO combination therapy to death (up to 60 months)
measure: Tumor characteristics
timeFrame: From Time of Initiation of 1L IO combination therapy to death (up to 60 months)
measure: IMDC risk score
timeFrame: From Time of Initiation of 1L IO combination therapy to death (up to 60 months)
measure: Number of lines of therapy received by each patient
timeFrame: From Time of Initiation of 1L IO combination therapy to death (up to 60 months)
measure: Treatment agents received at each line of therapy
timeFrame: From Time of Initiation of 1L IO combination therapy to death (up to 60 months)
measure: Duration of each line of therapy
timeFrame: From Time of Initiation of 1L IO combination therapy to death (up to 60 months)
measure: Time from discontinuation of previous line of therapy to initiation of subsequent line of therapy
timeFrame: From Time of Initiation of 1L IO combination therapy to death (up to 60 months)
measure: Reason for discontinuation for each line of therapy
timeFrame: From Time of Initiation of 1L IO combination therapy to death (up to 60 months)
measure: Time to treatment discontinuation (TTD)
timeFrame: From Time of Initiation of 1L IO combination therapy to death (up to 60 months)
measure: Time to next treatment (TTNT)
timeFrame: From Time of Initiation of 1L IO combination therapy to death (up to 60 months)
measure: Physician-assessed best response
timeFrame: From Time of Initiation of 1L IO combination therapy to death (up to 60 months)
measure: Overall survival
timeFrame: From Time of Initiation of 1L IO combination therapy to death (up to 60 months)
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Pfizer Headquarters
state: New York
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: