Locally Advanced or Metastatic Renal Cell CarcinomaUS NIS CaboNCT04353765
Study Of Cabozantinib Treatment In Patients With Unresectable, Locally Advanced Or Metastatic Renal Cell Carcinoma Who Progressed After Previous Treatment With Checkpoint Inhibitors
An observational study of Locally Advanced or Metastatic Renal Cell Carcinoma, run by Ipsen at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Locally Advanced or Metastatic Renal Cell Carcinoma
- What is being tested?
- Cabozantinib monotherapy and All authorized TKI monotherapies in advanced RCC per FDA label in advanced RCC
- How many people
- 247 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Jan 2020to 5 Jun 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: US Oncology network
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
- Being tested
- Cabozantinib monotherapy, All authorized TKI monotherapies in advanced RCC per FDA label in advanced RCC
- Medical subject headings
- Carcinoma, Renal Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cabozantinib monotherapyDrug
Also called Cabometyx
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 RCCDrug
As per authorized FDA label in advanced RCC
| Study group | Role | What they receive |
|---|---|---|
| cabozantinib arm | Not described Receives: Drug: Cabozantinib monotherapy | |
| non cabozantinib Tyrosine Kinase Inhibitors (TKI) arm | Not described Receives: Drug: All authorized TKI monotherapies in advanced RCC per FDA label in advanced RCC |
What is being measured
The primary outcome is the main question the study is designed to answer.
6 months Real-World Response Rate
Measured: 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
Measured: From start of index treatment until end of the treatment or death whichever occurs first
Overall Survival
Measured: From start of index treatment until death or end of the study whichever occurs first
Real-World Duration of Response
Measured: From date of index treatment response and the earliest date of progressive disease
Real-World Progression Free Survival
Measured: From start of index treatment until the earliest of death, end of study database, or evidence of Progressive Disease
Time to treatment discontinuation
Measured: 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
Measured: From start of index treatment until treatment discontinuation
Treatment duration
Measured: From start of index treatment until treatment discontinuation
Rate of hospitalisations
Number of patients who had been hospitalized (with reason of hospitalization when available)
Measured: From start of index treatment until treatment discontinuation
Drug discontinuation due to its toxicity
Number of patients discontinuing index regimens due to its toxicity
Measured: From start of index treatment until treatment discontinuation (through study completion)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2020
- Study start30 Jan 2020
- Primary completion5 Jun 2020
- Study completion5 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Locally Advanced or Metastatic Renal Cell CarcinomaStudies of the same condition, open and under way.
- More trials run by IpsenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 247 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ipsen
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ipsen Medical Director, Study director, Ipsen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04353765
- Sponsor's protocol ID
- F-FR-60000-066
- Acronym
- US NIS Cabo
- Status last verified
- Nov 2021
- First submitted
- 17 Apr 2020
- Last updated
- 17 Nov 2021
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04353765
- Acronym / sponsor ID
- US NIS Cabo / F-FR-60000-066
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 247 participants (actual)
- Lead sponsor
- IpsenIndustry (pharma, biotech, devices)
- Study start
- 30 Jan 2020 (actual)
- Primary completion
- 5 Jun 2020 (actual)
- Study completion
- 5 Jun 2020 (actual)
- First posted
- 20 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- US Oncology network
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cabozantinib monotherapyAlso: CabometyxIntervention description (FDA Label): kinase inhibitor indicated for the treatment of patients with advanced renal cell carcinoma (RCC). | Drug | cabozantinib arm |
| All authorized TKI monotherapies in advanced RCC per FDA label in advanced RCCAs per authorized FDA label in advanced RCC | Drug | non cabozantinib Tyrosine Kinase Inhibitors (TKI) arm |
Primary outcome
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
9 secondary outcomes
Real-World Overall Response Rate
Time frame: From start of index treatment until end of the treatment or death whichever occurs first
Overall Survival
Time frame: From start of index treatment until death or end of the study whichever occurs first
Real-World Duration of Response
Time frame: From date of index treatment response and the earliest date of progressive disease
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
Time to treatment discontinuation
Time frame: From start of index treatment until treatment discontinuation
Treatment dose reductions
Time frame: From start of index treatment until treatment discontinuation
Treatment duration
Time frame: From start of index treatment until treatment discontinuation
Rate of hospitalisations
Time frame: From start of index treatment until treatment discontinuation
Drug discontinuation due to its toxicity
Time frame: From start of index treatment until treatment discontinuation (through study completion)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Nov 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ipsen Medical Director study director
Ipsen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Locally Advanced or Metastatic Renal Cell Carcinoma, run by Ipsen at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Nov 2021.