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Recruiting NCT06934057

Cabozantinib and Nivolumab Among Older Patients With Renal Cell Carcinoma

Phase IV Interventional Kidney Cancer Renal Cell Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Nivolumab, Cabozantinib.
Who it may be relevant to
Registry conditions: Kidney Cancer, Renal Cell Cancer. Basic parameters: from 70 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • Drug Nivolumab
    Briefly, nivolumab is administered as an approximately 30-minute (240mg every 2 weeks) or 60-minute (480mg every 4 weeks) IV infusion.
  • Drug Cabozantinib
    Cabozantinib is a medication that is taken orally every day, once a day away from meals at the initial dose of 40 mg/day.

Primary outcome measures

  • Starting dose of Cabozantinib [Time frame: 24 weeks after treatment start]
  • Dose interruption of Cabozantinib [Time frame: 24 weeks after treatment start]
  • Dose modifications of Cabozantinib [Time frame: 24 weeks after treatment start]
Secondary outcome measures (8)
  • 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]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

France · 7 centers
  • Institut de Cancérologie de l'Ouest - Angers — Angers
  • Centre Georges François Leclerc — Dijon
  • Centre Léon Bérard — Lyon
  • Hôpital Tenon — Paris
  • Institut Universitaire Du Cancer Toulouse- Oncopole Claudius Regaud — Toulouse
  • CHU Tours - Hôpital Bretonneau — Tours
  • Gustave Roussy — Villejuif

Identifiers

NCT: NCT06934057 · 2024-516650-22-00 · 2024/3873

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗