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

Locally Advanced or Metastatic Renal Cell Carcinoma Clinical Trial

— US NIS Cabo  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04353765
• Other study ID #: F-FR-60000-066
• Status: Completed
• Start date: January 30, 2020
• Est. completion date: June 5, 2020

Study information

• Verified date: November 2021
• Source: Ipsen
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 247
• Est. completion date: June 5, 2020
• Est. primary completion date: June 5, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Renal Cell
• Locally Advanced or Metastatic Renal Cell Carcinoma

Intervention

Drug:
• Cabozantinib monotherapy
Intervention description (FDA Label): kinase inhibitor indicated for the treatment of patients with advanced renal cell carcinoma (RCC).
• All authorized TKI monotherapies in advanced RCC per FDA label in advanced RCC
As per authorized FDA label in advanced RCC

Locations

Country	Name	City	State
United States	McKesson Life Sciences	The Woodlands	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Ipsen

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Real-World Overall Response Rate		From start of index treatment until end of the treatment or death whichever occurs first
Secondary	Overall Survival		From start of index treatment until death or end of the study whichever occurs first
Secondary	Real-World Duration of Response		From date of index treatment response and the earliest date of progressive disease
Secondary	Real-World Progression Free Survival		From start of index treatment until the earliest of death, end of study database, or evidence of Progressive Disease
Secondary	Time to treatment discontinuation		From start of index treatment until treatment discontinuation
Secondary	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
Secondary	Treatment duration		From start of index treatment until treatment discontinuation
Secondary	Rate of hospitalisations	Number of patients who had been hospitalized (with reason of hospitalization when available)	From start of index treatment until treatment discontinuation
Secondary	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)