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Nivolumab versus Nivolumab + Bevacizumab

versus Nivolumab + Ipilimumab in

Metastatic Renal Cell Carcinoma (mRCC)

 
 
 Last updated: July 06, 2017
 STATUS: Ongoing, not recruiting (per ClinicalTrials.gov/NCT02210117)

WHO

is the trial for?

Patients with kidney cancer (Renal cell carcinoma, RCC) who currently meet the following criteria:

  • clear-cell component
  • advanced and/or metastatic disease
  • can have had prior systemic therapy for RCC
  • overall health status has to be good (ECOG less than 1)

WHAT

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

This phase II study seeks to clarify whether the new immunotherapies (one agent alone or in combination with other medications) can help to control metastatic kidney cancer.

This particular study investigates nivolumab as single agent against the combination of the immune-checkpoint inhibitors nivolumab and ipilimumab versus nivolumab plus bevacizumab in advanced renal cell carcinoma.

WHY

patients might want to participate?

This clinical trial offers patients an opportunity to access a new therapy 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 ongoing but not recruiting any more – 60 patients are currently expected to participate.

WHERE

is the trial available?

The trial will be available at the University of Texas MD Anderson Cancer Center, Houston Texas, USA.
Contact: Padmanee Sharma, MD, PHD
phone: 713-792-2830
 

STUDY

DESIGN

What does the study look like?

There will be 3 study arms (groups): all participating patients will be randomly divided (by a computer) in three groups. Please note that patients in all groups will receive an active medication. No patient receives a placebo.

Patients in one group will be assigned nivolumab (OpdivoTM) alone, patients in the second group get nivolumab (OpdivoTM) in combination with bevacizumab (AvastinTM). Patients in the third one will be treated with nivolumab (OpdivoTM) in combination with ipilimumab (Yervoy™).
  • nivolumab (Opdivo™) is a fully human monoclonal antibody targeting PD-1
  • bevacizumab (Avastin) is a monoclonal antibody targeting VEGF
  • ipilimumab (Yervoy™) is a fully human monoclonal antibody targeting CTLA-4

Arm 1:
Participant in this group, will receive nivolumab by vein over about 60 minutes on the first day of week 1, 3, and 5. Participant will not receive this drug again until week 14. Starting at week 14, participant may begin receiving the drug again every 2 weeks.

Arm 2:
In this group a combination of nivolumab and bevacizumab is given: both agents by vein on the first day of weeks 1, 3, and 5. Participant will not receive these drugs again until week 14. Starting at week 14, participant may begin receiving nivolumab alone every 2 weeks.

Arm 3:
In group 3 participants receive nivolumab and ipilimumab by vein on the first day of weeks 1 and 4. Participants will not receive these drugs again until week 14. Starting at week 14, participant may begin receiving nivolumab alone every 2 weeks.

HOW

do I get more information?

Patient organisations supporting kidney cancer patients in your country may offer additional information about the trial 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?