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

NCT04353765 | Completed FDA Drug

• 1 other identifier: F-FR-60000-066
• Study Type: observational
• Target: 247
• Locations: 1 country
• Sites: 1

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.

Conditions

Locally Advanced or Metastatic Renal Cell Carcinoma

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (9)

• 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

Study Arms (2)

cabozantinib arm

Drug: Cabozantinib monotherapy

non cabozantinib Tyrosine Kinase Inhibitors (TKI) arm

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

Interventions

Cabozantinib monotherapy DRUG

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

Also known as: Cabometyx

cabozantinib arm

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

As per authorized FDA label in advanced RCC

non cabozantinib Tyrosine Kinase Inhibitors (TKI) arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

US Oncology network

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Ipsen: lead

Study Sites (1)

McKesson Life Sciences

The Woodlands, Texas, 77380, United States

Location

MeSH Terms

Conditions

Carcinoma, Renal Cell

Interventions

cabozantinib

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Kidney Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases

Study Officials

• Ipsen Medical Director

  Ipsen

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 17, 2020
• First Posted: April 20, 2020
• Study Start: January 30, 2020
• Primary Completion: June 5, 2020
• Study Completion: June 5, 2020
• Last Updated: November 17, 2021

Record last verified: 2021-11

Locations

US (1)