Kidney CancerPhase 4CABOLDNCT06934057
Cabozantinib and Nivolumab Among Older Patients With Renal Cell Carcinoma
A Phase 4 study testing Nivolumab and Cabozantinib in people with Kidney Cancer and Renal Cell Cancer, run by Gustave Roussy, Cancer Campus, Grand Paris at 7 sites in France.
Trial summary
The goal of the study is to describe real-life use and exposition to nivolumab-cabozantinib among older patients with metastatic clear-cell renal cell cancer Read more about this study
- Who is it for?
- Ages 70 years and older
- Conditions the study is for
- Kidney Cancer, Renal Cell Cancer
- What is being tested?
- Nivolumab and Cabozantinib
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 7 sitesFrance
- Study dates
- 16 May 2025to Apr 2028
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
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 70 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Patients ≥ 70 years-old
- Confirmed advanced or metastatic renal-cell carcinoma
- Patients not previously treated in metastatic setting
- Performance Status 0 to 2
- Sexually active male patients must agree to use condom during the study and for at least 5 months after the last study treatment administration. Also, it is recommended their women of childbearing potential partner use a highly effective method of contraception.
- Patient should understand, sign, and date the written informed consent form prior to any protocol-specific procedures performed. Patient should be able and willing to comply with study visits and procedures as per protocol.
- Patients must be affiliated to a social security system or beneficiary of the same
Who cannot join
- Participation in another clinical study with an investigational product during the last four weeks and while on study treatment (Patients may be included in CABOLD if they are included in the arm B of CARE1 study EUCT N° 2023-503317-29-00)
- Performance Status > 2
- Any condition that represent a contraindication to Cabozantinib and/or Nivolumab, as described in summaries of products characteristics, including symptomatic untreated brain metastasis or active auto-immune disease requiring systemic immunosuppressant/modulator (thyroid or adrenal disorder are not an exclusion criteria)
- Any severe cardiovascular or thrombo-embolic event in the last three months
- Any situation for which exclusive palliative care intervention is recommended
- Patient under guardianship or deprived of his liberty by a judicial or administrative decision or incapable of giving its consent
Trial locations and contacts
7 sites in 1 country. Contact the study team or a site near you to ask about taking part.
7 sites in 1 country
France7 sites, 7 recruiting
- Not yet recruiting
Institut de Cancérologie de l'Ouest - Angers
Angers, 49055
Elouen BOUGHALEM, MD, +33 2 41 35 27 00, Elouen.boughalem@ico.unicancer.fr
- Not yet recruiting
Centre Georges François Leclerc
Dijon, 21079
Leila BENGRINE, MD, +33 380737528, lbengrine@cgfl.fr
- Not yet recruiting
Centre Léon Bérard
Lyon, 69373
Helen BOYLE, MD, +33 426556752, helen.boyle@lyon.unicancer.fr
- Not yet recruiting
Hôpital Tenon
Paris, 75020
Djamel GHEBRIOU, MD, +33 156017724, djamel.ghebriou@aphp.fr
- Not yet recruiting
Institut Universitaire Du Cancer Toulouse- Oncopole Claudius Regaud
Toulouse, 31059
Loïc MOUREY, MD, +33 531155156, mourey.loic@iuct-oncopole.fr
- Not yet recruiting
CHU Tours - Hôpital Bretonneau
Tours, 37044
Mathilde CANCEL, MD, +33 2 47 47 99 99, m.cancel@chu-tours.fr
- Recruiting
Gustave Roussy
Villejuif, 94800
Maxime FRELAUT, MD, +33 142115760, Maxime.frelaut@gustaveroussy.fr
About this study
Official title: Cabozantinib and Nivolumab Among Older Patients With Renal-cell Carcinoma, a Prospective Cohort With Geriatric, Pharmacologic and Patient-reported-outcome Evaluation
The goal of the study is to describe real-life use and exposition to nivolumab-cabozantinib among older patients with metastatic clear-cell renal cell cancer
Read the detailed description
This study will be a prospective, multicentric, single-arm cohort. Patients will receive Nivolumab-Cabozantinib association per standard. All patients will benefit of geriatric evaluation (G-CODE) at inclusion, and a multimodal and reinforced follow-up, including medical oncologist, geriatrician nurse of doctor, phone calls, and optional pharmacological follow-up for Cabozantinib.
- Conditions
- Kidney Cancer, Renal Cell Cancer
- Being tested
- Nivolumab, Cabozantinib
- Keywords
- renal cell carcinoma, kidney cancer, cabozantinib, nivolumab, elderly patients, geriatric population
- Medical subject headings
- Kidney Neoplasms, Carcinoma, Renal Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NivolumabDrug
Also called OPDIVO
Briefly, nivolumab is administered as an approximately 30-minute (240mg every 2 weeks) or 60-minute (480mg every 4 weeks) IV infusion.
CabozantinibDrug
Also called CABOMETYX
Cabozantinib is a medication that is taken orally every day, once a day away from meals at the initial dose of 40 mg/day.
| Study group | Role | What they receive |
|---|---|---|
| Cabozantinib-Nivolumab | Experimental | The patient will be treated according to standard of care Nivolumab Cabozantinib. Receives: Drug: Nivolumab; Drug: Cabozantinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Starting dose of Cabozantinib
Primary outcome measure is treatment patterns, which includes starting dose of cabozantinib.
Measured: 24 weeks after treatment start
Dose interruption of Cabozantinib
Primary outcome measure is treatment patterns of Cabozantinib, which includes the proportion of patients who experience any temporary dose interruption within the first 24 weeks of treatment.
Measured: 24 weeks after treatment start
Dose modifications of Cabozantinib
Primary outcome measure is treatment patterns, which includes the proportion of patients who experience any form of dose modification of Cabozantinib related to all grade toxicity within the first 24 weeks of treatment.
Measured: 24 weeks after treatment start
Secondary outcomes (8)
Overall response rate based on radiological evaluation
Overall response rate based on best radiological response rate with local RECIST 1.1 evaluation observed in the 12 months of the study
Measured: 12 months after treatment start
Overall-survival
Defined as the time between the date of inclusion and the date of death whatever the cause. Patients alive at the date of last follow-up visit will be censored at that date.
Measured: 12 months after treatment start
Progression free survival
Progression free survival, defined by the time between inclusion date and the date of observation of a progression of the disease according to RECIST 1.1 or death of the patient (all causes combined) or date of last follow-up if the patient is alive without progression or lost to follow up.
Measured: 12 months after treatment start
Duration of response
It is defined as the time from first radiological evidence of response (partial or complete response) to disease progression or death among patients who achieve complete or partial response.
Measured: 12 months after treatment start
Frequency of adverse events according to CTCAE V5
Tolerance is evaluated based on physicians reports.
Measured: 12 months after treatment start
Frequency of adverse events according to PRO-CTCAE
Tolerance is evaluated based on patients reports.
Measured: 12 months after treatment start
Quality of life - Patient-related outcomes - FACT-G
Patients reported quality of life is evaluated based on Functional Assessment of Cancer Therapy - General (FACT-G) questionnaire. It is an 27 item questionnaire, ranging from 0 to 108 score. Higher scores indicate better quality of life
Measured: At baseline, and every 3 months after treatment start, up to 12 months after treatment start
Quality of life - Patient-related outcomes - FACIT TS-G
Patients reported quality of life is evaluated based on Functional Assessment of Chronic Illness Therapy - Treatment Satisfaction - General (FACIT TS-G) questionnaire. The score range goes from 0 to 70 score. Higher scores indicate greater satisfaction with treatment
Measured: Every 3 months after treatment start, up to 12 months after treatment start
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2025
- Study start16 May 2025
- Primary completionApr 2028 (estimated)
- Study completionApr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney CancerStudies of the same condition, open and under way.
- More trials run by Gustave Roussy, Cancer Campus, Grand ParisThe 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gustave Roussy, Cancer Campus, Grand Paris
- Sponsor type
- University, hospital or other
- Collaborators
- Ipsen
- Responsible party
- Sponsor
- Investigators
- Maxime FRELAUT, MD, Principal investigator, Gustave Roussy, Cancer Campus, Grand Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06934057
- Sponsor's protocol ID
- 2024-516650-22-00
- Other IDs
- 2024/3873
- Acronym
- CABOLD
- Status last verified
- Sep 2025
- First submitted
- 9 Apr 2025
- Last updated
- 24 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cabozantinib and Nivolumab Among Older Patients With Renal-cell Carcinoma, a Prospective Cohort With Geriatric, Pharmacologic and Patient-reported-outcome Evaluation
- ClinicalTrials.gov ID
- NCT06934057
- Acronym / sponsor ID
- CABOLD / 2024-516650-22-00
- Conditions
- Kidney Cancer, Renal Cell Cancer
- Keywords
- renal cell carcinoma, kidney cancer, cabozantinib, nivolumab, elderly patients, geriatric population
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Gustave Roussy, Cancer Campus, Grand ParisUniversity, hospital or other
- Collaborators
- Ipsen
- Study start
- 16 May 2025 (actual)
- Primary completion
- Apr 2028 (estimated)
- Study completion
- Apr 2028 (estimated)
- First posted
- 18 Apr 2025 (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.
The goal of the study is to describe real-life use and exposition to nivolumab-cabozantinib among older patients with metastatic clear-cell renal cell cancer
Detailed description
This study will be a prospective, multicentric, single-arm cohort. Patients will receive Nivolumab-Cabozantinib association per standard. All patients will benefit of geriatric evaluation (G-CODE) at inclusion, and a multimodal and reinforced follow-up, including medical oncologist, geriatrician nurse of doctor, phone calls, and optional pharmacological follow-up for Cabozantinib.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cabozantinib-Nivolumab | Experimental | Drug: Nivolumab, Drug: CabozantinibThe patient will be treated according to standard of care Nivolumab Cabozantinib. |
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (7 listed)
- Patients ≥ 70 years-old
- Confirmed advanced or metastatic renal-cell carcinoma
- Patients not previously treated in metastatic setting
- Performance Status 0 to 2
- Sexually active male patients must agree to use condom during the study and for at least 5 months after the last study treatment administration. Also, it is recommended their women of childbearing potential partner use a highly effective method of contraception.
Key exclusion criteria (6 listed)
- Participation in another clinical study with an investigational product during the last four weeks and while on study treatment (Patients may be included in CABOLD if they are included in the arm B of CARE1 study EUCT N° 2023-503317-29-00)
- Performance Status > 2
- Any condition that represent a contraindication to Cabozantinib and/or Nivolumab, as described in summaries of products characteristics, including symptomatic untreated brain metastasis or active auto-immune disease requiring systemic immunosuppressant/modulator (thyroid or adrenal disorder are not an exclusion criteria)
- Any severe cardiovascular or thrombo-embolic event in the last three months
- Any situation for which exclusive palliative care intervention is recommended
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 |
|---|---|---|
| NivolumabAlso: OPDIVOBriefly, nivolumab is administered as an approximately 30-minute (240mg every 2 weeks) or 60-minute (480mg every 4 weeks) IV infusion. | Drug | Cabozantinib-Nivolumab |
| CabozantinibAlso: CABOMETYXCabozantinib is a medication that is taken orally every day, once a day away from meals at the initial dose of 40 mg/day. | Drug | Cabozantinib-Nivolumab |
Primary outcome
Starting dose of Cabozantinib
Time frame: 24 weeks after treatment start
Primary outcome measure is treatment patterns, which includes starting dose of cabozantinib.
Dose interruption of Cabozantinib
Time frame: 24 weeks after treatment start
Primary outcome measure is treatment patterns of Cabozantinib, which includes the proportion of patients who experience any temporary dose interruption within the first 24 weeks of treatment.
Dose modifications of Cabozantinib
Time frame: 24 weeks after treatment start
Primary outcome measure is treatment patterns, which includes the proportion of patients who experience any form of dose modification of Cabozantinib related to all grade toxicity within the first 24 weeks of treatment.
8 secondary outcomes
Overall response rate based on radiological evaluation
Time frame: 12 months after treatment start
Overall-survival
Time frame: 12 months after treatment start
Progression free survival
Time frame: 12 months after treatment start
Duration of response
Time frame: 12 months after treatment start
Frequency of adverse events according to CTCAE V5
Time frame: 12 months after treatment start
Frequency of adverse events according to PRO-CTCAE
Time frame: 12 months after treatment start
Quality of life - Patient-related outcomes - FACT-G
Time frame: At baseline, and every 3 months after treatment start, up to 12 months after treatment start
Quality of life - Patient-related outcomes - FACIT TS-G
Time frame: Every 3 months after treatment start, up to 12 months after treatment start
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2025.
- Individual participant dataSharing planned: No
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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.
Maxime FRELAUT, MD principal investigator
Gustave Roussy, Cancer Campus, Grand Paris
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Nivolumab and Cabozantinib in people with Kidney Cancer and Renal Cell Cancer, run by Gustave Roussy, Cancer Campus, Grand Paris at 7 sites in France.
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 7 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 24 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in France. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Maxime Frelaut, MD (+33 1 42 11 57 60, Maxime.FRELAUT@gustaveroussy.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Starting dose of Cabozantinib (time frame: 24 weeks after treatment start). The study lists 3 primary outcomes in all. 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 24 Sep 2025.