Study Of Cabozantinib Treatment In Patients With Unresectable, Locally Advanced Or Metastatic Renal Cell Carcinoma Who Progressed After Previous Treatment With Checkpoint Inhibitors
- Conditions
- Locally Advanced or Metastatic Renal Cell Carcinoma
- Interventions
- Drug: All authorized TKI monotherapies in advanced RCC per FDA label in advanced RCC
- Registration Number
- NCT04353765
- Lead Sponsor
- Ipsen
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 247
- 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.
- 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 & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description cabozantinib arm Cabozantinib monotherapy - non cabozantinib Tyrosine Kinase Inhibitors (TKI) arm All authorized TKI monotherapies in advanced RCC per FDA label in advanced RCC -
- Primary Outcome Measures
Name Time Method 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
Name Time Method Real-World Duration of Response From date of index treatment response and the earliest date of progressive disease 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 Time to treatment discontinuation From start of index treatment until treatment discontinuation Treatment dose reductions From start of index treatment until treatment discontinuation Number of patients who had dose reduction/change as compared to the starting dose during index period
Drug discontinuation due to its toxicity From start of index treatment until treatment discontinuation (through study completion) Number of patients discontinuing index regimens due to its toxicity
Real-World Progression Free Survival From start of index treatment until the earliest of death, end of study database, or evidence of Progressive Disease Treatment duration From start of index treatment until treatment discontinuation Rate of hospitalisations From start of index treatment until treatment discontinuation Number of patients who had been hospitalized (with reason of hospitalization when available)
Trial Locations
- Locations (1)
McKesson Life Sciences
🇺🇸The Woodlands, Texas, United States