Study Of Cabozantinib Treatment In Patients With Unresectable, Locally Advanced Or Metastatic Renal Cell Carcinoma Who Progressed After Previous Treatment With Checkpoint Inhibitors

Ipsen247 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

247

Conditions

Locally Advanced or Metastatic Renal Cell Carcinoma

Interventions

Cabozantinib monotherapyDRUG

Intervention description (FDA Label): kinase inhibitor indicated for the treatment of patients with advanced renal cell carcinoma (RCC).

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

6 months Real-World Response Rate

Time frame: From start of index treatment until 6 months of follow up or end of the treatment or death whichever occurs first

Secondary Outcomes

Real-World Overall Response Rate

Time frame: From start of index treatment until end of the treatment or death whichever occurs first

Overall Survival

Time frame: From start of index treatment until death or end of the study whichever occurs first

Real-World Duration of Response

Time frame: From date of index treatment response and the earliest date of progressive disease

Real-World Progression Free Survival

Time frame: From start of index treatment until the earliest of death, end of study database, or evidence of Progressive Disease

Time to treatment discontinuation

Time frame: From start of index treatment until treatment discontinuation

Treatment dose reductions

Number of patients who had dose reduction/change as compared to the starting dose during index period

Time frame: From start of index treatment until treatment discontinuation

Treatment duration

Time frame: From start of index treatment until treatment discontinuation

Rate of hospitalisations

Number of patients who had been hospitalized (with reason of hospitalization when available)

Time frame: From start of index treatment until treatment discontinuation

Drug discontinuation due to its toxicity

Number of patients discontinuing index regimens due to its toxicity

Time frame: From start of index treatment until treatment discontinuation (through study completion)

Study Of Cabozantinib Treatment In Patients With Unresectable, Locally Advanced Or Metastatic Renal Cell Carcinoma Who Progressed After Previous Treatment With Checkpoint Inhibitors

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes