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)
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Metastatic Renal Cell Carcinoma
- Sponsor
- Pfizer
- Enrollment
- 494
- Locations
- 1
- Primary Endpoint
- Demographical characteristics
- Status
- Completed
- Last Updated
- 2 years ago
Overview
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.
Investigators
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
Outcomes
Primary Outcomes
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)
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
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)
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)
Date of nephrectomy (if applicable)
Time Frame: From Time of Initiation of 1L IO combination therapy to death (up to 60 months)
Prior nephrectomy status
Time Frame: From Time of Initiation of 1L IO combination therapy to death (up to 60 months)
Duration of each line of therapy
Time Frame: 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
Time Frame: From Time of Initiation of 1L IO combination therapy to death (up to 60 months)
Date of mRCC diagnosis
Time Frame: From Time of Initiation of 1L IO combination therapy to death (up to 60 months)
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)
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)
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
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
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
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