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NCT Number: NCT06934057

Cabozantinib and Nivolumab Among Older Patients With Renal Cell Carcinoma

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

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Key information

Conditions

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

Age range

70 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Institut de Cancérologie de l'Ouest - Angers, Angers, France

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Nivolumab

Drug

Briefly, nivolumab is administered as an approximately 30-minute (240mg every 2 weeks) or 60-minute (480mg every 4 weeks) IV infusion.

Other names: OPDIVO

Cabozantinib

Drug

Cabozantinib is a medication that is taken orally every day, once a day away from meals at the initial dose of 40 mg/day.

Other names: CABOMETYX

Primary outcomes

  1. Starting dose of Cabozantinib

    Time frame: 24 weeks after treatment start

    Primary outcome measure is treatment patterns, which includes starting dose of cabozantinib.

  2. 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.

  3. 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.

Secondary outcomes

  1. Overall response rate based on radiological evaluation

    Time frame: 12 months after treatment start

    Overall response rate based on best radiological response rate with local RECIST 1.1 evaluation observed in the 12 months of the study

  2. Overall-survival

    Time frame: 12 months after treatment start

    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.

  3. Progression free survival

    Time frame: 12 months after treatment start

    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.

  4. Duration of response

    Time frame: 12 months after treatment start

    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.

  5. Frequency of adverse events according to CTCAE V5

    Time frame: 12 months after treatment start

    Tolerance is evaluated based on physicians reports.

  6. Frequency of adverse events according to PRO-CTCAE

    Time frame: 12 months after treatment start

    Tolerance is evaluated based on patients reports.

  7. 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

    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

  8. Quality of life - Patient-related outcomes - FACIT TS-G

    Time frame: Every 3 months after treatment start, up to 12 months after treatment start

    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

Study contacts

Contact information is provided by the study sponsor or research team.

Maia Claveau CLAVEAU

CONTACT

[email protected]

+33 1 42 11 53 49

Maxime Frelaut, MD

CONTACT

[email protected]

+33 1 42 11 57 60

Sponsors and collaborators

Lead sponsor

Gustave Roussy, Cancer Campus, Grand Paris

Other

Collaborators

  • Ipsen

Registry information

Official study title

Cabozantinib and Nivolumab Among Older Patients With Renal-cell Carcinoma, a Prospective Cohort With Geriatric, Pharmacologic and Patient-reported-outcome Evaluation

Acronym: CABOLD

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
Apr 18, 2025
Registry last updated
Sep 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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