Clinical trial NCT04353765: Study Of Cabozantinib Treatment In Patients With Unresectable, Locally Advanced Or Metastatic Renal Cell Carcinoma Who Progressed After Previous Treatment With Checkpoint Inhibitors
Official title: Non - Interventional, Retrospective Study Of Cabozantinib Treatment In Patients With Unresectable, Locally Advanced Or Metastatic Renal Cell Carcinoma Who Progressed After Previous Treatment With Checkpoint Inhibitors
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Locally Advanced or Metastatic Renal Cell Carcinoma
Lead sponsor: Ipsen
Sponsor class: INDUSTRY
First posted: 2020-04-20
Enrollment: 247
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: US Oncology network

Brief summary: To understand the epidemiology, treatment patterns and outcomes of patients with metastatic Renal Cell Carcinoma (mRCC). Data from mRCC patients who received cabozantinib versus non-cabozantinib Tyrosine Kinase Inhibitor (TKI) (a type of targeted cancer drug) immediately after Check Point Inhibitor (CPI) treatment (a type of immunotherapy that blocks proteins that stop the immune system from attacking the cancer cells) in US community oncology practices will be analyzed.


Eligibility criteria: Inclusion Criteria:

* Evidence of metastatic Renal Cell Carcinoma (mRCC) during the study period (May 01, 2016 to March 31, 2020);
* Patients who received cabozantinib or non-cabozantinib TKI regimens during identification period (May 01, 2016 to September 30, 2019);
* Patients who received CPIs, as monotherapy, or in combination with a cytotoxic T-lymphocyte-associated antigen 4 (CTLA-4) inhibitor (e.g. ipilimumab+nivolumab), as the latest treatment for mRCC administrated before cabozantinib or other TKI therapy;
* Patients ≥ 18 years of age as of their index date
* Patients who received care at a US Oncology Network site
* Patients with ≥ 2 visits within the US Oncology Network.

Exclusion Criteria:

* Patients enrolled in a clinical trial at any time during index period
* Patients receiving treatment for another documented primary cancer diagnoses during the study period

Primary outcomes:
measure: 6 months Real-World Response Rate
timeFrame: From start of index treatment until 6 months of follow up or end of the treatment or death whichever occurs first
Secondary outcomes:
measure: Real-World Overall Response Rate
timeFrame: From start of index treatment until end of the treatment or death whichever occurs first
measure: Overall Survival
timeFrame: From start of index treatment until death or end of the study whichever occurs first
measure: Real-World Duration of Response
timeFrame: From date of index treatment response and the earliest date of progressive disease
measure: Real-World Progression Free Survival
timeFrame: From start of index treatment until the earliest of death, end of study database, or evidence of Progressive Disease
measure: Time to treatment discontinuation
timeFrame: From start of index treatment until treatment discontinuation
measure: Treatment dose reductions
timeFrame: From start of index treatment until treatment discontinuation
measure: Treatment duration
timeFrame: From start of index treatment until treatment discontinuation
measure: Rate of hospitalisations
timeFrame: From start of index treatment until treatment discontinuation
measure: Drug discontinuation due to its toxicity
timeFrame: From start of index treatment until treatment discontinuation (through study completion)
Other outcomes:
Locations:
city: The Woodlands
country: United States
facility: McKesson Life Sciences
state: Texas
Study officials:
affiliation: Ipsen
name: Ipsen Medical Director
role: STUDY_DIRECTOR
References: