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

Metastatic Renal Cell Carcinoma Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05858749
• Other study ID #: A4061100
• Status: Completed
• Start date: June 20, 2022
• Est. completion date: November 30, 2022

Study information

• Verified date: May 2023
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 494
• Est. completion date: November 30, 2022
• Est. primary completion date: November 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Renal Cell
• Metastatic Renal Cell Carcinoma

Locations

Country	Name	City	State
United States	Pfizer Headquarters	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Demographical characteristics	Gender Age at time of 1L initiation Race Region indicator (i.e., US vs. ex-US)	From Time of Initiation of First-line (1L) Immuno-oncology (IO) combination therapy to death (up to 60 months)
Primary	Date of mRCC diagnosis		From Time of Initiation of 1L IO combination therapy to death (up to 60 months)
Primary	Prior nephrectomy status		From Time of Initiation of 1L IO combination therapy to death (up to 60 months)
Primary	Date of nephrectomy (if applicable)		From Time of Initiation of 1L IO combination therapy to death (up to 60 months)
Primary	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)	From Time of Initiation of 1L IO combination therapy to death (up to 60 months)
Primary	IMDC risk score	Assessed on index date and at initiation of each LOT	From Time of Initiation of 1L IO combination therapy to death (up to 60 months)
Primary	Number of lines of therapy received by each patient		From Time of Initiation of 1L IO combination therapy to death (up to 60 months)
Primary	Treatment agents received at each line of therapy		From Time of Initiation of 1L IO combination therapy to death (up to 60 months)
Primary	Duration of each line of therapy		From Time of Initiation of 1L IO combination therapy to death (up to 60 months)
Primary	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)
Primary	Reason for discontinuation for each line of therapy		From Time of Initiation of 1L IO combination therapy to death (up to 60 months)
Primary	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	From Time of Initiation of 1L IO combination therapy to death (up to 60 months)
Primary	Time to next treatment (TTNT)	Defined as time from the initiation of 1L treatment to initiation of subsequent therapy or death	From Time of Initiation of 1L IO combination therapy to death (up to 60 months)
Primary	Physician-assessed best response	Overall best response rate (complete or partial) Stable disease Progressive disease	From Time of Initiation of 1L IO combination therapy to death (up to 60 months)
Primary	Overall survival	Defined as the time between initiation of 1L IO combination therapy to death	From Time of Initiation of 1L IO combination therapy to death (up to 60 months)

External Links

•   To obtain contact information for a study center near you, click here.