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Cabozantinib Plus Nivolumab Alone or in Combination With Ipilimumab in Patients With Advanced/Metastatic Urothelial Carcinoma and Other Genitourinary Tumours

 
 
 Last updated: July 06, 2017
 STATUS: Recruiting (accepting new patients) (per ClinicalTrials.gov/NCT02496208)

WHO

is the trial for?

Patients with advanced/metastatic urothelial carcinoma or any other genitourinary tumour (such as kidney cancer) who currently meet the following criteria:

  • histologically confirmed diagnosis of metastatic genitourinary solid tumor
  • advanced and/or metastatic disease
  • at least one evaluable site of disease or appearance of one new bone lesion
  • treated with at least one line of standard therapy
  • prior immunomodulating therapy (with the exception of any therapy on the PD-1/PDL-1 axis) is allowed
  • tumour tissue has to be available
  • overall health status has to be good (ECOG performance status less than or equal to 1/Karnofsky greater than or equal to 70%)

WHAT

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

This phase-I study seeks to clarify whether a combination of medications (a tyrosine kinase inhibitor + new immunotherapy agents) can help to control metastatic urothelial carcinoma or any other genitourinary tumour.

It investigates the combinatin of the tyrosine kinase inhibitor cabozantinib in combination with the antibody nivolumab against the combination of cabozantinib plus nivolumab plus a second antibody called ipilimumab. In this phase 1 different dosages are administered to find the best regimen for further studies. 

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 open (recruiting) – 66 patients are currently expected to participate.

WHERE

is the trial available?

The trial was available in 6 cancer centres in the USA.
For a complete list of trial locations, please download the following document:

STUDY

DESIGN

What does the study look like?

There will be 2 study arms (groups) for patients with kidney cancer: all participating patients will be randomly divided (by a computer) in 2 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 cabozantinib (CabometyxTM) plus nivolumab (OpdivoTM), patients in the second group get cabozantinob plus nivolumab in combination with ipilimumab (Yervoy™). All agents are administered in different dosages to define the best regimen for further trials.
  • cabozantinib (CabometyxTM) is a tyrosine kiniase inhibitor (targeted therapy)
  • nivolumab (Opdivo™) is a fully human monoclonal antibody targeting PD-1
  • ipilimumab (Yervoy™) is a fully human monoclonal antibody targeting CTLA-4

Arm 1:
Participants in this group, will receive cabozantinib by mouth once daily +
nivolumab in a vein once every 2 weeks for up to 84 weeks in different dosages.

Arm 2:
In this group a combination of cabozantinib + nivolumab and iplimumab is given: cabozantinib by mouth once daily plus nivolumab and ipilimumab in a vein once every 3 weeks for up to 12 weeks, then nivolumab alone in a vein every 3 weeks. All agents are administred in different dosages.

Once the safe starting dose has been determined a separate, small expansion cohort of patients with bladder cancer will be evaluated in order to obtain preliminary estimates of efficacy of the drug combinations.

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?