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NCT Number: NCT04106349

Observational Real-life Study of Cabozantinib in Monotherapy or in Combination With Nivolumab in Advanced Renal Cell Carcinoma (RCC)

The purpose of this study is to describe the real-life use of Cabometyx® in monotherapy or in combination with nivolumab in Belgium in patients with advanced or metastatic Renal Cell Carcinoma (1st, 2nd and later lines of treatment)

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Advanced or Metastatic Renal Cell Carcinoma 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 Urogenital Diseases Urogenital Neoplasms Urologic Diseases Urologic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Onze-Lieve-vrouw Ziekenhuis Aalst, Aalst, Belgium

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Males or females aged 18 years and older
  • Patients scheduled to receive Cabometyx® in monotherapy or in combination with nivolumabfor advanced or metastatic renal cell carcinoma
  • Decision to treat patients with Cabometyx® in monotherapy or in combination with nivolumab has to be taken prior to and independent from participation in the clinical study
  • Provision of written informed consent

Exclusion criteria

  • Participation in another interventional clinical study at the same time
  • Previous participation in this clinical study

Treatment and study plan

Primary outcomes

  1. Treatment line

    Time frame: Baseline

    Treatment line will be assessed at baseline. It is a percentage of patients receiving cabozantinib as 1st, 2nd or later lines of treatment or cabozantinib in monotherapy or in combination with nivolumab as 1st line of treatment.

  2. Dose reductions and reasons

    Time frame: From baseline up to 6 to 8 weeks after cabozantinib initiation and within 10 days of cabozantinib stop

    Number of dose reductions and reason

  3. Treatment interruptions and reason

    Time frame: From baseline up to 6 to 8 weeks after cabozantinib initiation and within 10 days of cabozantinib stop

    Number of treatment interruptions and reason

  4. Treatment discontinuations and reason

    Time frame: From baseline up to 6 to 8 weeks after cabozantinib initiation and within 10 days of cabozantinib stop

    Number of patients with permanent discontinuation and reason

  5. Alternative dose schedule

    Time frame: From baseline until the end of study up to 9 months

    Number of patients with schedules other than 1 pill at fixed dose/day for the total treatment period

  6. Mean number of any dose modification

    Time frame: From baseline up to 6 to 8 weeks after cabozantinib initiation and within 10 days of cabozantinib stop

  7. Median number of any dose modification

    Time frame: From baseline up to 6 to 8 weeks after cabozantinib initiation and within 10 days of cabozantinib stop

  8. Median time to any first dose modification

    Time frame: From baseline up to 6 to 8 weeks after cabozantinib initiation and within 10 days of cabozantinib stop

  9. Median time to end of treatment

    Time frame: From baseline until the end of study up to 9 months

  10. Duration of treatment exposure

    Time frame: From baseline until the end of study up to 9 months

  11. Dose prescribed at initiation

    Time frame: Baseline

    Number of patients with dose of 60 mg/day, 40 mg/day or 20 mg/day at baseline

  12. Average daily dose

    Time frame: From baseline until the end of study up to 9 months

    Estimation of average daily dose received by subject during the treatment exposure

Secondary outcomes

  1. Change in Quality of Life score

    Time frame: From baseline up to 6 to 8 weeks after cabozantinib initiation and within 10 days of cabozantinib stop

    Changes in quality of life data by comparing changes in scores on Using the National Comprehensive Cancer Network/Functional Assessment of Cancer Therapy Kidney Symptom Index-19 (NFKSI-19). It describes the severity, interference, and frequency rates.

  2. Progression Free Survival (PFS)

    Time frame: From baseline until the end of study up to 9 months

    Radiological progression using RECIST 1.1 or investigator assessed or according to local standard of care or death; PFS evaluated at least every 12 weeks under treatment with cabozantinib

  3. Objective Response Rate

    Time frame: From baseline until the end of study up to 9 months

    Percent of patients with partial and complete response during the treatment with cabozantinib

  4. Disease Control Rate

    Time frame: From baseline until the end of study up to 9 months

    Percent of patients with stable disease, partial and complete response during the treatment with cabozantinib

Sponsors and collaborators

Lead sponsor

Ipsen

Industry

Registry information

Official study title

REPLICA: Real Patient Life Treatment With Cabozantinib in Monotherapy or in Combination With Nivolumab in Patients With Advanced or Metastatic RCC: a Descriptive and Prospective Non Interventional Study.

Acronym: REPLICA

Important dates

Study start
2020
Primary completion
2027
Study completion
2027
First posted
Sep 27, 2019
Registry last updated
Jul 30, 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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