Clinical trial NCT04175262: Clinical Outcomes For Patients With Metastatic Renal Cell Carcinoma (mRCC) Who Received Sunitinib After 1st Line Immune-oncology (IO) Treatments
Official title: Clinical Effectiveness of Second-Line Sunitinib Following Immune-oncologic (IO) Therapy in Patients With Metastatic Renal Cell Carcinoma in the International Metastatic Renal Cell Carcinoma Database (IMDC)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Metastatic Renal Cell Carcinoma (mRCC)
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
Collaborators: name: International Metastatic Renal Cell Carcinoma Database Consortium (IMDC)
name: Analysis Group, Inc.
First posted: 2019-11-25
Enrollment: 102
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: patients with diagnosis of mRCC who initiated sunitinib as 2nd line treatment

Brief summary: The study aims to assess clinical outcomes in mRCC patients treated with sunitinib in second-line following IO therapy in real world clinical practices.


Eligibility criteria: Inclusion Criteria:

* Patients must meet all of the following inclusion criteria to be eligible for inclusion in the study:

  * Diagnosed with mRCC
  * Received IO therapy as 1L therapy
  * Received sunitinib as 2L therapy
  * Age 18 years or over at the time of mRCC diagnosis
  * Actively treated at an IMDC clinical center (to avoid incomplete data)

Exclusion Criteria:

None

Primary outcomes:
measure: Overall Survival (OS) After Initiation of Second Line Sunitinib Therapy
timeFrame: From the date of initiation of second line sunitinib to the date of death or censored date, up to a maximum of approximately 5.5 years (from the data collected and observed retrospectively for approximately 4 months)
measure: Time to Treatment Discontinuation (TTD) of Second Line Sunitinib Therapy
timeFrame: From the date of initiation of second line sunitinib to discontinuation or censored date, up to a maximum of approximately 5.5 years (from the data collected and observed retrospectively for approximately 4 months)
measure: Time to Treatment Discontinuation (TTD) of First Line Immune-Oncologic Therapy
timeFrame: From the initiation of immune-oncologic therapy to discontinuation of immune-oncologic therapy (approximately up to 2 years)
measure: Number of Participants Classified According to Reasons for Second-Line Sunitinib Treatment Discontinuation
timeFrame: From the date of initiation of second line sunitinib to discontinuation or censored date, up to a maximum of approximately 5.5 years (from the data collected and observed retrospectively for approximately 4 months)
measure: Objective Response Rate (ORR) After Initiation of Second Line Sunitinib Therapy
timeFrame: From the date of initiation of second line sunitinib to the date of PR and CR or censored date, up to a maximum of approximately 5.5 years (from the data collected and observed retrospectively for approximately 4 months)
measure: Percentage of Participants With Progressive Disease (PD) After Initiation of Second Line Sunitinib Therapy
timeFrame: From the date of initiation of second line sunitinib to occurrence of disease progression, up to a maximum of approximately 5.5 years (from the data collected and observed retrospectively for approximately 4 months)
measure: Percentage of Participants With Stable Disease (SD) After Initiation of Second Line Sunitinib Therapy
timeFrame: From the date of initiation of second line sunitinib to the date stable disease or censored date, up to a maximum of approximately 5.5 years (from the data collected and observed retrospectively for approximately 4 months)
measure: Time From First Line Immune-Oncologic Therapy Discontinuation to Initiation of Second Line Sunitinib Therapy
timeFrame: From the discontinuation of immune-oncologic therapy to the initiation of sunitinib therapy (approximately up to 2 years)
measure: Number of Participants Classified According to Reasons for First-Line Immune-Oncologic Treatment Discontinuation
timeFrame: From the date of initiation of first line Immune-Oncologic to discontinuation or follow-up (approximately up to 2 years)
Secondary outcomes:
Other outcomes:
Locations:
city: Calgary
country: Canada
facility: University of Calgary
state: Alberta
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: