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Completed

NCT Number: NCT04353765

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.

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Key information

Conditions

Locally Advanced or Metastatic Renal Cell Carcinoma Adenocarcinoma Carcinoma Carcinoma, Renal Cell Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Kidney Neoplasms Male Urogenital Diseases Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Urogenital Diseases Urogenital Neoplasms Urologic Diseases Urologic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

McKesson Life Sciences

The Woodlands, Texas, 77380, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cabozantinib monotherapy

Drug

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

Other names: Cabometyx

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

Drug

As per authorized FDA label in advanced RCC

Primary outcomes

  1. 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

  1. Real-World Overall Response Rate

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

  2. Overall Survival

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

  3. Real-World Duration of Response

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

  4. 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

  5. Time to treatment discontinuation

    Time frame: From start of index treatment until treatment discontinuation

  6. Treatment dose reductions

    Time frame: 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

  7. Treatment duration

    Time frame: From start of index treatment until treatment discontinuation

  8. Rate of hospitalisations

    Time frame: From start of index treatment until treatment discontinuation

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

  9. Drug discontinuation due to its toxicity

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

    Number of patients discontinuing index regimens due to its toxicity

Sponsors and collaborators

Lead sponsor

Ipsen

Industry

Registry information

Official study 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

Acronym: US NIS Cabo

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Apr 20, 2020
Registry last updated
Nov 17, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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