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Completed

NCT Number: NCT05361434

A Study of the Effectiveness of Cabozantinib in Combination With Nivolumab as First-line Treatment of Advanced Renal Cell Carcinoma (aRCC) in Adults

The purpose of this study is to collect data to describe the safety and effectiveness of cabozantinib and nivolumab in combination as a first-line treatment in adults with aRCC with clear cell-component, according to real-world clinical practice. The decision to prescribe cabozantinib and nivolumab in combination will be made prior to, and independently from, the decision to enrol the participant in study.

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Key information

Conditions

Advanced Renal Cell Carcinoma

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CHU St Pierre & Brugmann, Brussels, Belgium

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Participants with diagnosis of aRCC with clear-cell component
  • Participants with no prior systemic treatment for aRCC with clear-cell component;
  • Physician-initiated decision to treat with cabozantinib and nivolumab in combination (prior to study enrolment), according to Cabometyx® and Opdivo® approved local labels;

Exclusion criteria

  • Current participation in an investigational program with any intervention which could possibly interfere the treatment and impact this study;
  • History of allergy or hypersensitivity to Cabometyx® or Opdivo® components.

Treatment and study plan

Primary outcomes

  1. Overall survival (OS) rate (death of any cause) from the start of cabozantinib in combination with nivolumab.

    Time frame: At 18 months follow up

Secondary outcomes

  1. Tumor median progression-free survival (PFS) time

    Time frame: Every month until month 4, and every 3 months after month 4 up to 42 month or disease progression

    Including clinical and radiographic assessments defined as the time between the start date of cabozantinib in combination with nivolumab and the date of progression or death of any cause. The Kaplan-Meier method will be used to estimate median PFS.

  2. Proportion of participants who achieve partial or complete response (Objective Response Rate (ORR))

    Time frame: Every month until month 4, and every 3 months after month 4 up to 42 month or disease progression

    Assessed by the investigator

  3. Duration of response (DOR)

    Time frame: Every month until month 4, and every 3 months after month 4 up to 42 month or disease progression

    Defined as the interval from the date of first response (complete or partial) to treatment with cabozantinib in combination with nivolumab, to progressive disease or death

  4. Proportion of participants who achieve complete response, partial response or stable disease (Disease Control Rate (DCR)).

    Time frame: Every month until month 4, and every 3 months after month 4 up to 42 months or disease progression.

  5. Time of response (TTR)

    Time frame: Every month until month 4, and every 3 months after month 4 up to 42 months or disease progression

    Defined as the time between the start date of cabozantinib in combination with nivolumab and date of first response (complete or partial).

  6. Pattern of use of cabozantinib under real-world practice conditions.

    Time frame: Every month until month 4, and every 3 months after month 4 up to 42 months or disease progression

  7. Pattern of use of nivolumab under real-world practice conditions.

    Time frame: Every month until month 4, and every 3 months after month 4 up to 42 months or disease progression

  8. Incidence of treatment-emergent Adverse Events (TEAEs) including nonserious Adverse Events (AEs), and Serious Advers Events (SAEs).

    Time frame: Up to 42 months or disease progression

    All AEs will be coded according to the Medical Dictionary for Regulatory Activities (MedDRA) and will be classified by MedDRA PT and SOC.

  9. Change in disease-related symptoms

    Time frame: Change from baseline at each visit up to 42 months

    Assessed by the Functional Assessment of Cancer Therapy Kidney Cancer Symptom Index - Disease Related Symptoms (FKSI-DRS) questionnaire

  10. Change in pain

    Time frame: Change from baseline at each visit up to 42 months

    Assessed by the Numerical Pain Rating Scale (NPRS)

  11. Percentage of participants receiving subsequent anticancer therapies following cabozantinib and nivolumab discontinuation

    Time frame: Up to 42 months.

    Including: Sequences of treatment; drug names and duration of treatment; and reason for end of treatment line

Sponsors and collaborators

Lead sponsor

Ipsen

Industry

Registry information

Official study title

A Prospective Observational International Study of Cabozantinib Tablets in Combination With Nivolumab as First-line Treatment of Advanced Renal Cell Carcinoma in Adults

Acronym: CaboCombo

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
May 4, 2022
Registry last updated
Jun 1, 2026

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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