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A Study of Nivolumab for Patients With Localized Kidney Cancer Undergoing a Nephrectomy (PROSPER RCC Study)

Trial ID: NCT03055013
Kidney Cancer Type: Any


Background:
Nivolumab (Opdivo®) is an immunotherapy drug that has already been approved for the treatment of advanced kidney cancer in Canada. It works by targeting a molecule called PD-1 to reactivate the body’s own immune response to target and destroy cancer cells.

However, this drug is not yet used for patients with localized kidney cancer.

The current standard of care for patients with localized kidney cancer is nephrectomy, followed by active surveillance. This means that your doctor will monitor your recovery closely with regular tests and scans, but you will not receive any new drugs or therapies until there are signs that your cancer has returned.


The Trial:
This study will investigate whether Nivolumab, when administered before and after nephrectomy, can improve surgical outcomes. Specifically, whether the Nivolumab is able to delay or prevent cancer from returning in patients who have recently had their kidney removed.

Accordingly, patients will be randomly assigned to one of two groups:

  • Group 1 will receive two rounds of Nivolumab prior to their surgery, followed by a maintenance schedule given every 2-4 weeks for a maximum of 12 rounds.
  • Group 2 will receive the standard of care treatment currently employed in Canada: nephrectomy followed by active surveillance only.

Both groups will be monitored for up to 10 years post-surgery to determine whether Nivolumab had any significant effect on surgical outcome.


Basic Eligibility:

  • Any subtype
  • Cancer must be confined to the kidney
  • No prior treatments are permitted
    • No drug therapy (i.e. Sunitinib (Sutent®))
    • No radiation therapies

Additional eligibility criteria will apply. Please speak to your doctor.

 

Find out more about this study.
Hospital / Cancer CentrePrincipal InvestigatorLocationTrial Status
Hospital / Cancer CentreCentre Hospitalier Universitaire de Sherbrooke Principal InvestigatorDr. Michael Pavic LocationSherbrooke, QC Trial StatusRecruiting
Hospital / Cancer CentreWindsor Regional Cancer Centre Principal InvestigatorDr. Sindu Kanjeekal LocationWindsor, ON Trial StatusRecruiting
Hospital / Cancer CentrePrincess Margaret Hospital Principal InvestigatorDr. Antonio Finelli LocationToronto, ON Trial StatusRecruiting
Hospital / Cancer CentreSaint Catharines General Principal InvestigatorDr. Michael Levesque LocationSaint Catharines, ON Trial StatusRecruiting
Hospital / Cancer CentreLondon Regional Cancer Program Principal InvestigatorDr. Nicholas Power LocationLondon, ON Trial StatusRecruiting
Hospital / Cancer CentreKingston Health Sciences Centre Principal InvestigatorDr. Francisco Badilo LocationKingston, ON Trial StatusRecruiting
Hospital / Cancer CentreJuravinski Cancer Centre Principal InvestigatorDr. Anil Kapoor LocationHamilton, ON Trial StatusRecruiting
Hospital / Cancer CentreSaint Joseph's Healthcare Principal InvestigatorDr. Anil Kapoor LocationHamilton, ON Trial StatusRecruiting
Hospital / Cancer CentreQEII Health Sciences Centre Principal InvestigatorDr. Lori Wood LocationHalifax, NS Trial StatusRecruiting
Hospital / Cancer CentreThe Moncton Hospital Principal InvestigatorDr. Mahmoud Abdelsalam LocationMoncton, NB Trial StatusRecruiting
Hospital / Cancer CentreTom Baker Cancer Centre Principal InvestigatorDr. Daniel Heng LocationCalgary, AB Trial StatusRecruiting
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