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

NCT05858749 | Completed

• 1 other identifier: A4061100
• Study Type: observational
• Target: 494
• Locations: 1 country
• Sites: 1

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.

Conditions

Metastatic Renal Cell Carcinoma

Keywords

Kidney cancer; Metastatic renal cell carcinoma (mRCC); International Metastatic Renal Cell Carcinoma Database Consortium (IMDC); Immunotherapy.

Outcome Measures

Primary Outcomes (15)

• 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)

• 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

  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)

• 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)

• 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)

  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)

• 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)

• 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)

• 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)

Study Arms (1)

Patients with mRCC

Patients with mRCC in the IMDC

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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)

Sponsors & Collaborators

• Pfizer: lead

Study Sites (1)

Pfizer Headquarters

New York, New York, 10017, United States

Location

Related Links

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

MeSH Terms

Conditions

Carcinoma, Renal Cell; Kidney Neoplasms

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 18, 2023
• First Posted: May 15, 2023
• Study Start: June 20, 2022
• Primary Completion: November 30, 2022
• Study Completion: November 30, 2022
• Last Updated: February 27, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)