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

Ipsen

Status: Completed

Conditions: Locally Advanced or Metastatic Renal Cell Carcinoma

Treatments: Drug: All authorized TKI monotherapies in advanced RCC per FDA label in advanced RCC; Drug: Cabozantinib monotherapy

Study type: Observational

Funder types: Industry

Identifiers

NCT04353765

F-FR-60000-066

Details and patient eligibility

About

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.

Enrollment: 247 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

247 participants in 2 patient groups

cabozantinib arm

Treatment:

Drug: Cabozantinib monotherapy

non cabozantinib Tyrosine Kinase Inhibitors (TKI) arm

Treatment:

Drug: All authorized TKI monotherapies in advanced RCC per FDA label in advanced RCC