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Completed

NCT Number: NCT05858749

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

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Pfizer Headquarters

New York, 10017, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Demographical characteristics

    Time frame: 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)

  2. Date of mRCC diagnosis

    Time frame: From Time of Initiation of 1L IO combination therapy to death (up to 60 months)

  3. Prior nephrectomy status

    Time frame: From Time of Initiation of 1L IO combination therapy to death (up to 60 months)

  4. Date of nephrectomy (if applicable)

    Time frame: From Time of Initiation of 1L IO combination therapy to death (up to 60 months)

  5. Tumor characteristics

    Time frame: 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)

  6. IMDC risk score

    Time frame: 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

  7. Number of lines of therapy received by each patient

    Time frame: From Time of Initiation of 1L IO combination therapy to death (up to 60 months)

  8. Treatment agents received at each line of therapy

    Time frame: From Time of Initiation of 1L IO combination therapy to death (up to 60 months)

  9. Duration of each line of therapy

    Time frame: From Time of Initiation of 1L IO combination therapy to death (up to 60 months)

  10. Time from discontinuation of previous line of therapy to initiation of subsequent line of therapy

    Time frame: From Time of Initiation of 1L IO combination therapy to death (up to 60 months)

  11. Reason for discontinuation for each line of therapy

    Time frame: From Time of Initiation of 1L IO combination therapy to death (up to 60 months)

  12. Time to treatment discontinuation (TTD)

    Time frame: 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

  13. Time to next treatment (TTNT)

    Time frame: 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

  14. Physician-assessed best response

    Time frame: 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

  15. Overall survival

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study 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)

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
May 15, 2023
Registry last updated
Jun 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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