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A Study of Nivolumab Combined With Cabozantinib or Nivolumab and Ipilimumab Combined With Cabozantinib Compared to Sunitinib in Previously Untreated Advanced or Metastatic Renal Cell Carcinoma
 Phase 3, 1014 Patients 

 Last updated: November 29, 2017
 STATUS: Open, recruiting (accepting new patients) (per ClinicalTrials.gov/NCT03141177)

WHO

is the trial for?

Patients with advanced or metastatic kidney cancer (Renal cell carcinoma, RCC) who currently meet the following criteria:
  • clear-cell component, including patients whose tumours may also have sarcomatoid features
  • no prior systemic therapy for RCC with the following exception:
    • One prior adjuvant or neoadjuvant therapy for completely resectable RCC if such therapy did not include an agent that targets VEGF or VEGF receptors and if recurrence occurred at least 6 months after the last dose of adjuvant or neoadjuvant therapy

WHAT

is the key question that this trial is attempting to answer?

This phase 3 study seeks to clarify whether a combination of medications (a tyrosine kinase inhibitor (TKI) plus one or two immunotherapy agents) is superior to one of the standard first-line therapies for kidney cancer.

The key question this study seeks to answer is whether a combination of two or three therapies administered together can improve upon the efficacy of one existing standard of care therapy. Results from each study group will be compared to evaluate side effects, and also to determine which type of therapy is suitable for which patients.

WHY

patients might want to participate?

This clinical trial offers patients an opportunity to access a new therapy or combination of therapies that may be effective for kidney cancer. This trial will further support the research in kidney cancer and potentially help other patients with kidney cancer. The trial might or might not have benefit in your individual case. For more about the importance and benefits of joining clinical trials, please click here.

WHEN

will the trial be open?

The study is open (recruiting) – 1014 patients are currently expected to participate.

WHERE

is the trial available?

The trial will be available in various cancer centres world-wide.
For a complete list of trial locations, please open the following link:
 

STUDY

DESIGN

What does the study look like?

The study has been designed to compare three groups of patients: all participating patients will be randomly divided (by a computer) into one of the three groups. Please note that patients in all groups will receive an active medication. No patient will receive a placebo.

Medications used in the three groups of this study include:
  • cabozantinib (CabometyxTM) is a tyrosine kinase inhibitor (targeted therapy), already approved in many countries for the treatment of metastatic renal cell carcinoma
  • nivolumab (Opdivo™) is a fully human monoclonal antibody targeting PD-1 that is already approved as monotherapy for renal cell carcinoma
  • ipilimumab (Yervoy™) is a fully human monoclonal antibody targeting CTLA-4 that is not yet approved for renal cell carcinoma
  • sunitinib (Sutent™) is an oral, small-molecule, multi-targeted receptor tyrosine kinase (RTK) inhibitor, already approved for the treatment of renal cell carcinoma
Group 1:
Participants in this group, will receive cabozantinib + nivolumab in combination. Cabozantinib is an oral tablet taken daily. Nivolumab is an intravenous infusion injected into the vein every 3 weeks.

Group 2:
Participants in this group will receive a combination of cabozantinib + nivolumab + ipilimumab. Cabozantinib is an oral tablet taken daily. Nivolumab is an intravenous infusion injected into the vein every 3 weeks. Ipilimumab is also given intravenously on specified days according to dosing requirements.

Group 3:
Participants in this group will receive sunitinib. Sunitinib is an oral tablet taken daily in cycles that consist of 4 weeks of daily dosing, followed by a two-week break.

HOW

do I get more information?

Patient organisations supporting kidney cancer patients in your country may offer additional information about the trial, current recruitment status, and key contacts. Click here for a list of patient organisations serving kidney cancer patients. If there are no such organisations in your country, please email us for more information: This email address is being protected from spambots. You need JavaScript enabled to view it.

CONNECT

with other patients on this trial

If you want to connect with other patients considering or participating in this trial, you can find them here: List of organisations worldwide.

SHARE

your experience 

You want to share your experience on this trial?
Send us an e-mail to: This email address is being protected from spambots. You need JavaScript enabled to view it.
Note that your experience would be helpful for other patients and patient organisations.

RESULTS

of the study

No results are available at this time. Future results will be linked here.
Disclaimer: This is a patient-friendly summary of the clinical trial which has been provided for informational purposes only. Patients should consult their physician about any clinical trial opportunity.
 
Back to clinical trials overview: How can I find an IO clinical trial for my cancer?