Metastatic Renal Cell CarcinomaCABOGENNCT06548867
Retrospective Analysis of Patients With Metastatic Renal Cell Carcinoma Treated With CABOzantinib
An observational study of Metastatic Renal Cell Carcinoma, run by Gruppo Oncologico Italiano di Ricerca Clinica at 1 site in Italy.
Trial summary
CABOGEN is a Observational, retrospective, multicenter study that will enroll patients with metastatic clear cell renal carcinoma (mccRCC) treated with cabozantinib after one or more previous lines of treatment that included TKIs, immune checkpoint inhibitors or mTOR inhibitors. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Renal Cell Carcinoma
- What is being tested?
- Cabozantinib
- How many people
- 80 participants
- Where
- 1 siteItaly
- Study dates
- 28 May 2024to 30 Jun 2025
- 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: patients with metastatic clear cell renal carcinoma (mRCC) who are long-lasting responders to treatment with cabozantinib and patients who are not long-lasting responders to the cabozantinib treatment. Cabozantinib treatment receive after one or more previuos therapy for mRCC
Who may be able to join
- Age ≥ 18 years.
- Patients with histological diagnosis of predominantly clear cell carcinoma
- Availability of the tumor tissue from the primary tumor and/or a metastatic site for the genomic profiling analysis not older than 5 years.
- Evaluable disease according to RECIST criteria v 1.1
- Treatment with cabozantinib after one or more previous therapies for mRCC
- Patient progressed from the start to cabozantinib therapy within 3 months or after 9 months
- Any prognosis group according to the IMDC risk score
- Signed informed consent must be obtained for living patients. Patients who died and patient untraceable will be analyzed based on the Authorization no. 9/2016 of the Italian Data Protector Supervisor.
Who cannot join
- Non-availability of tumor tissue from the primary tumor or a metastatic site for biomarker analysis
- Patient progressed between 3 and 9 months from the beginning of treatment with cabozantinib.
- Non-availability of clinical information useful to evaluate the IMDC risk group at baseline.
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
AUSL-IRCCS of Reggio Emilia
Reggio Emilia, 42123
Carmine Pinto, MD, +39 0522296614, carmine.pinto@ausl.re.it
About this study
Official title: Retrospective Analysis of Patients With Metastatic Renal Cell Carcinoma Treated With CABOzantinib: a GENomic Signature for Describing Long-lasting Response
CABOGEN is a Observational, retrospective, multicenter study that will enroll patients with metastatic clear cell renal carcinoma (mccRCC) treated with cabozantinib after one or more previous lines of treatment that included TKIs, immune checkpoint inhibitors or mTOR inhibitors.
Read the detailed description
The aim of this study is to describe the genomic profiling of patients with metastatic renal cell carcinoma (mRCC) who are long-lasting responders to treatment with cabozantinib and patients who are not long-lasting responders to the cabozantinib treatment.
The study plan to enroll about 80 patients in 10 Italian centers:
Group A: 40 patients defined as long-lasting responders (PFS ≥ 9 months) Group B: 40 patients defined as primary refractories to cabozantinib (PFS ≤ 3 months)
Tissue samples from nephrectomy or from a metastatic site will be used to perform genomic profiling not older than 5 years.Tissue should be formalin-fixed, paraffin-embedded (FFPE).
Genomic profiling will be performed with a hybrid capture-based next-generation sequencing assay (FoundationONE). The sample will be assayed for all coding exons of 324 cancer-related genes plus select introns from 34 genes that are frequently rearranged in cancer. Sequencing will be performed to a mean exon coverage depth of >500X. The resulting sequences will be analyzed for all classes of genomic alteration, including short variant alterations, copy number alterations, and selected gene fusions or rearrangements.
- Conditions
- Metastatic Renal Cell Carcinoma
- Being tested
- Cabozantinib
- Keywords
- Metastatic Renal Cell Carcinoma, Genomic signature, long lasting response, cabozantinib treatment
- 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.
CabozantinibDrug
Patients must have been treated with cabozantinib after one or more previous therapies for mRCC, as per clinical practise.
| Study group | Role | What they receive |
|---|---|---|
| Group A: long-lasting responders | Patient long-lasting responders (PFS ≥9 months) to cabozantinib Receives: Drug: Cabozantinib | |
| Group B: primary refractories | Patient progressed from the start to cabozantinib therapy within 3 months Receives: Drug: Cabozantinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Genomic profiling
to describe genomic profiling of patients with mRCC who are long-lasting responders (PFS ≥9 months) to cabozantinib and describe genomic profiling of patients with rapid disease progression following cabozntinib therapy (PFS≤ 3 months)
Measured: 12 months
Secondary outcomes (3)
Overall Survival (OS)
to describe OS based according to detected genomic profiling
Measured: 12 months
Overall response rate (ORR)
to describe ORR according to the detected genomic profiling
Measured: 12 months
Duration of response (DOR)
to describe duration of response (DOR) according to the detected genomic profilingto describe the genomic profiling according to treatment line (second, third or subsequent) to describe anamnestic characteristics (weight, ECOG PS, sites of metastasis, response to previous treatment lines)
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2024
- Study start28 May 2024
- Primary completion30 Jun 2025 (estimated)
- Study completion30 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Renal Cell CarcinomaStudies of the same condition, open and under way.
- 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
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gruppo Oncologico Italiano di Ricerca Clinica
- Sponsor type
- University, hospital or other
- Collaborators
- Yghea, Ipsen
- Responsible party
- Sponsor
- Investigators
- Carmine Pinto, MD, Principal investigator, AUSL/IRCCS of Reggio EmiliaCristina Masini, MD, Study chair, AUSL/IRCCS of Reggio EmiliaStefania Di Girolamo, MD, Study chair, AUSL/IRCCS of Reggio Emilia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06548867
- Sponsor's protocol ID
- GOIRC-08-2018
- Acronym
- CABOGEN
- Status last verified
- Aug 2024
- First submitted
- 8 Aug 2024
- Last updated
- 12 Aug 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retrospective Analysis of Patients With Metastatic Renal Cell Carcinoma Treated With CABOzantinib: a GENomic Signature for Describing Long-lasting Response
- ClinicalTrials.gov ID
- NCT06548867
- Acronym / sponsor ID
- CABOGEN / GOIRC-08-2018
- Conditions
- Metastatic Renal Cell Carcinoma
- Keywords
- Metastatic Renal Cell Carcinoma, Genomic signature, long lasting response, cabozantinib treatment
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Gruppo Oncologico Italiano di Ricerca ClinicaUniversity, hospital or other
- Collaborators
- Yghea, Ipsen
- Study start
- 28 May 2024 (actual)
- Primary completion
- 30 Jun 2025 (estimated)
- Study completion
- 30 Jun 2025 (estimated)
- First posted
- 12 Aug 2024 (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.
CABOGEN is a Observational, retrospective, multicenter study that will enroll patients with metastatic clear cell renal carcinoma (mccRCC) treated with cabozantinib after one or more previous lines of treatment that included TKIs, immune checkpoint inhibitors or mTOR inhibitors.
Detailed description
The aim of this study is to describe the genomic profiling of patients with metastatic renal cell carcinoma (mRCC) who are long-lasting responders to treatment with cabozantinib and patients who are not long-lasting responders to the cabozantinib treatment.
The study plan to enroll about 80 patients in 10 Italian centers:
Group A: 40 patients defined as long-lasting responders (PFS ≥ 9 months) Group B: 40 patients defined as primary refractories to cabozantinib (PFS ≤ 3 months)
Tissue samples from nephrectomy or from a metastatic site will be used to perform genomic profiling not older than 5 years.Tissue should be formalin-fixed, paraffin-embedded (FFPE).
Genomic profiling will be performed with a hybrid capture-based next-generation sequencing assay (FoundationONE). The sample will be assayed for all coding exons of 324 cancer-related genes plus select introns from 34 genes that are frequently rearranged in cancer. Sequencing will be performed to a mean exon coverage depth of >500X. The resulting sequences will be analyzed for all classes of genomic alteration, including short variant alterations, copy number alterations, and selected gene fusions or rearrangements.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A: long-lasting responders | – | Drug: CabozantinibPatient long-lasting responders (PFS ≥9 months) to cabozantinib |
| Group B: primary refractories | – | Drug: CabozantinibPatient progressed from the start to cabozantinib therapy within 3 months |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients with metastatic clear cell renal carcinoma (mRCC) who are long-lasting responders to treatment with cabozantinib and patients who are not long-lasting responders to the cabozantinib treatment. Cabozantinib treatment receive after one or more previuos therapy for mRCC
Key inclusion criteria (8 listed)
- Age ≥ 18 years.
- Patients with histological diagnosis of predominantly clear cell carcinoma
- Availability of the tumor tissue from the primary tumor and/or a metastatic site for the genomic profiling analysis not older than 5 years.
- Evaluable disease according to RECIST criteria v 1.1
- Treatment with cabozantinib after one or more previous therapies for mRCC
Key exclusion criteria (3 listed)
- Non-availability of tumor tissue from the primary tumor or a metastatic site for biomarker analysis
- Patient progressed between 3 and 9 months from the beginning of treatment with cabozantinib.
- Non-availability of clinical information useful to evaluate the IMDC risk group at baseline.
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 |
|---|---|---|
| CabozantinibPatients must have been treated with cabozantinib after one or more previous therapies for mRCC, as per clinical practise. | Drug | Group A: long-lasting responders, Group B: primary refractories |
Primary outcome
Genomic profiling
Time frame: 12 months
to describe genomic profiling of patients with mRCC who are long-lasting responders (PFS ≥9 months) to cabozantinib and describe genomic profiling of patients with rapid disease progression following cabozntinib therapy (PFS≤ 3 months)
3 secondary outcomes
Overall Survival (OS)
Time frame: 12 months
Overall response rate (ORR)
Time frame: 12 months
Duration of response (DOR)
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2024.
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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.
Carmine Pinto, MD principal investigator
AUSL/IRCCS of Reggio Emilia
Cristina Masini, MD study chair
AUSL/IRCCS of Reggio Emilia
Stefania Di Girolamo, MD study chair
AUSL/IRCCS of Reggio Emilia
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 Metastatic Renal Cell Carcinoma, run by Gruppo Oncologico Italiano di Ricerca Clinica at 1 site in Italy.
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 8 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 12 Aug 2024. 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 Italy. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Carmine Pinto, MD (+39 0522296614, carmine.pinto@ausl.re.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Genomic profiling (time frame: 12 months). 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 12 Aug 2024.