Observational study of Cabozantinib with or without Nivolumab for advanced kidney cancer
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.
This study looks at how well Cabozantinib alone or with Nivolumab works for people in Belgium with advanced kidney cancer who are getting these treatments as part of their regular care.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 150 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Ipsen Industry-sponsored |
| Drugs / interventions | nivolumab |
| Locations | 25 sites (Aalst and 24 other locations) |
| Trial ID | NCT04106349 on ClinicalTrials.gov |
What this trial studies
This study aims to observe the real-life use of Cabometyx® either alone or in combination with nivolumab in patients with advanced or metastatic renal cell carcinoma in Belgium. It will include patients who are scheduled to receive these treatments as part of their standard care, with the decision to treat made independently of the study. The study will gather data on the effectiveness and safety of these treatment options in a real-world setting.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older who are scheduled to receive Cabometyx® in monotherapy or in combination with nivolumab for advanced or metastatic renal cell carcinoma.
Not a fit: Patients currently participating in another interventional clinical study or who have previously participated in this study may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide valuable insights into the effectiveness of Cabozantinib and nivolumab in treating advanced kidney cancer, potentially improving patient outcomes.
How similar studies have performed: While this study is observational, similar studies evaluating the effectiveness of Cabozantinib and nivolumab have shown promising results in treating advanced renal cell carcinoma.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Aalst and 24 other locations
- Onze-Lieve-vrouw Ziekenhuis Aalst — Aalst, Belgium (Recruiting)
- Vivalia Hôpital d'Arlon — Arlon, Belgium (Withdrawn)
- Imeldaziekenhuis — Bonheiden, Belgium (Recruiting)
- Clinique Saint-Luc Bouge — Bouge, Belgium (Recruiting)
- AZ Sint-Jan Brugge — Brugge, Belgium (Recruiting)
- AZ Sint-Lucas — Brugge, Belgium (Recruiting)
- Hôpital Erasme — Brussels, Belgium (Withdrawn)
- UZ Brussel — Brussels, Belgium (Recruiting)
- Chirec Delta — Brussels, Belgium (Withdrawn)
- Ziekenhuis Oost-Limburg Genk — Genk, Belgium (Recruiting)
- Universitair Ziekenhuis Gent — Gent, Belgium (Recruiting)
- Virga Jessa Ziekenhuis — Hasselt, Belgium (Withdrawn)
- Hôpital de Jolimont — La Louvière, Belgium (Recruiting)
- CHC MontLegia — Liège, Belgium (Recruiting)
- CHR Citadelle Liège — Liège, Belgium (Recruiting)
- CHU Liège / Sart-Tilman — Liège, Belgium (Recruiting)
- Hôpital Ambroise-Paré Mons — Mons, Belgium (Recruiting)
- CHU Charleroi - site André Vésale — Montigny-le-Tilleul, Belgium (Recruiting)
- Clinique Saint-Pierre — Ottignies, Belgium (Recruiting)
- AZ Delta — Roeselare, Belgium (Recruiting)
- AZ Glorieux — Ronse, Belgium (Recruiting)
- Chwapi — Tournai, Belgium (Recruiting)
- AZ Turnhout — Turnhout, Belgium (Recruiting)
- CHR Verviers — Verviers, Belgium (Recruiting)
- UCL Namur - site Godinne — Yvoir, Belgium (Withdrawn)
Study contacts
- Study coordinator: Ipsen Recruitment Enquiries
- Email: clinical.trials@ipsen.com
- Phone: see email
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.