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Cabozantinib and Nivolumab among older patients with renal-cell carcinoma, a prospective cohort with geriatric, pharmacologic and patient-reported-outcome evaluation (CABOLD)
EU CTIS ID: 2024-516650-22-00
What this study is testing
To describe real-life use and exposition to nivolumab-cabozantinib among older patients with metastatic clear-cell renal cell cancer
- Therapeutic use (Phase IV)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Patients ≥ 70 years-old
- Confirmed advanced or clear-cell 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.
You likely can't join if
- 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
See the full eligibility criteria
- Patients ≥ 70 years-old
- Confirmed advanced or clear-cell 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
- 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
- Participation in another clinical study with an investigational product during the last four weeks and while on study treatment (except: patients Version 1.0 02/10/24 Confidential Page 6 of 68 included in CARE1 may be included in CABOLD if they are included in the arm B of CARE1 study (EUCT N° 2023-503317-29-00))
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.