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)

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

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 Overview

• Status: Completed
• Conditions: Locally Advanced or Metastatic Renal Cell Carcinoma
• Intervention / Treatment: Drug: Cabozantinib monotherapy; Drug: All authorized TKI monotherapies in advanced RCC per FDA label in advanced RCC

• Study Type: Observational
• Enrollment (Actual): 247

Contacts and Locations

Study Locations

• United States
  • Texas
    • The Woodlands, Texas, United States, 77380
      • McKesson Life Sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

US Oncology network

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
cabozantinib arm	Drug: Cabozantinib monotherapy; Intervention description (FDA Label): kinase inhibitor indicated for the treatment of patients with advanced renal cell carcinoma (RCC).; Other Names: Cabometyx
non cabozantinib Tyrosine Kinase Inhibitors (TKI) arm	Drug: All authorized TKI monotherapies in advanced RCC per FDA label in advanced RCC; As per authorized FDA label in advanced RCC

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
6 months Real-World Response Rate	From start of index treatment until 6 months of follow up or end of the treatment or death whichever occurs first

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Real-World Overall Response Rate		From start of index treatment until end of the treatment or death whichever occurs first
Overall Survival		From start of index treatment until death or end of the study whichever occurs first
Real-World Duration of Response		From date of index treatment response and the earliest date of progressive disease
Real-World Progression Free Survival		From start of index treatment until the earliest of death, end of study database, or evidence of Progressive Disease
Time to treatment discontinuation		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	From start of index treatment until treatment discontinuation
Treatment duration		From start of index treatment until treatment discontinuation
Rate of hospitalisations	Number of patients who had been hospitalized (with reason of hospitalization when available)	From start of index treatment until treatment discontinuation
Drug discontinuation due to its toxicity	Number of patients discontinuing index regimens due to its toxicity	From start of index treatment until treatment discontinuation (through study completion)

Collaborators and Investigators

• Sponsor: Ipsen

Study record dates

Study Major Dates

• Study Start (Actual): January 30, 2020
• Primary Completion (Actual): June 5, 2020
• Study Completion (Actual): June 5, 2020

Study Registration Dates

• First Submitted: April 17, 2020
• First Submitted That Met QC Criteria: April 17, 2020
• First Posted (Actual): April 20, 2020

Study Record Updates

• Last Update Posted (Actual): November 17, 2021
• Last Update Submitted That Met QC Criteria: November 11, 2021
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Kidney Diseases; Urologic Diseases; Adenocarcinoma; Neoplasms, Glandular and Epithelial; Kidney Neoplasms; Carcinoma, Renal Cell; Carcinoma
• Other Study ID Numbers: F-FR-60000-066

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes