header logo en

 

10 facts web



UNISoN

 
Nivolumab then Nivolumab+Ipilimumab;
Sequential in Non-clear cell Renal Cell Carcinoma
 
 Phase 2, 85 patients
 Last updated: April 09, 2018
 STATUS: Recruiting (accepting new patients) (per ClinicalTrials.gov/NCT03177239)

WHO

is the trial for?

Patients with advanced or metastatic kidney cancer that is a rare kidney cancer, (i.e. not primarily “clear cell”, a non-clear cell renal cell carcinoma) who currently meet the following criteria:
  • tumour pathology must show renal cell carcinoma (RCC) with a non-clear cell histology including:
    • Papillary Renal Cell Carcinoma Type 1
    • Papillary Renal Cell Carcinoma Type 2
    • Chromophobe Renal Cell Carcinoma
    • Sarcomatoid Renal Cell Carcinoma
    • Xp11 Translocation Carcinoma
    • Other renal carcinoma NOS may be eligible
    • NB urothelial or transitional cell carcinoma of the kidney, renal pelvis, ureter are unfortunately not eligible; some bladder cancer trials allow and include these patients
  • tumour sample has to be available (previously resected or fresh biopsy)
  • at least one spot of the cancer can be easily seen and measured on scans (metastatic/unresectable lesion (target lesion) measurable according to RECIST 1.1)
  • overall health status has to be good; people must be capable of all self-cares, and be able to perform light work e.g. housework, office work (ECOG 0-1)
  • no history of significant autoimmune disease
  • no previous treatment with immunotherapy drugs

WHAT

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

This study aims to evaluate the safety, tolerability and effectiveness of new treatments for kidney cancer called nivolumab and ipilimumab. The study is in two parts; in the first instance patients take nivolumab alone. If this treatment is not effective, and if patients remain well, they may move onto the second part of the trial, where they can take nivolumab + ipilimumab. There is no placebo.

The reason to offer one treatment alone, followed by two treatments together is that it is thought that the double treatment is known to have more side-effects, but may also potentially be effective in people in whom the single first treatment (nivolumab alone) has not helped.

Nivolumab and ipilimumab are experimental treatments in this trial. This means that they are not an approved treatment for non-clear cell kidney cancer in Australia. They are standard treatments in melanoma, and are being tested in dozens of other types of cancers.

WHY

patients might want to participate?

In this clinical trial, ANZUP will evaluate whether new immune treatments can help people with rare kidney cancers (non-clear cell cancer). These rare forms of kidney cancer occur in up to 25% of people with kidney cancer; and because they are rare there are no treatments currently reimbursed in Australia. The trial might or might not have benefit in your individual case.

WHEN

will the trial be open?

The study is open (currently recruiting) – 85 patients in Australia and New Zealand are currently expected to participate.

WHERE

is the trial available?

UNISoN is an investigator-led study conducted by the Australian & New Zealand Urogenital & Prostate Cancer Trials Group (@ANZUPtrials); the trial is open at sites across Australia, please see "kidney cancer unison trial" for the closest site for you

STUDY

DESIGN

What does the study look like?

All eligible patients will receive treatment in the first part of the trial. Patients who require further treatment will be evaluated to receive an additional therapy in part two. No patient will receive a placebo.

1st Part: all patients will be treated with nivolumab for up to 12 months. If the patient’s disease progresses on nivolumab alone before 12 months, and they remain well overall, patients may enter the 2nd part of the trial.

During the 1st part, nivolumab will be given intravenously once every two weeks for 12 months, unless patients experience prohibitive toxicity, disease progression or death.
  • nivolumab (Opdivo™) is a fully human monoclonal antibody targeting PD-1 that is already approved for renal cell carcinoma and other cancers, but not specifically for non-clear renal cell carcinoma
2nd Part: For those patients whose disease progresses in Part 1, nivolumab will be given in combination with another drug, ipilimumab
  • ipilimumab (Yervoy™) is a fully human monoclonal antibody targeting CTLA-4 that is not yet approved for renal cell carcinoma
Ipilimumab combined with nivolumab will be given intravenously once every three weeks for up to four times. Following the ipilimumab infusions, the nivolumab alone can be continued at two-weekly intervals unless there is prohibitive toxicity, disease progression or death, for 12 months’ treatment in total.
 
UNISoN
 

1) Nivolumab will be given intravenously once every two weeks for a minimum of 8 weeks and up to 12 months, unless patients experience prohibitive toxicity, disease progression or death.

2) Ipilimumab combined with nivolumab will be given intravenously once every three weeks for up to four times. Following the ipilimumab infusions, the nivolumab alone can be continued at two-weekly intervals unless there is prohibitive toxicity, disease progression or death, for 12 months’ treatment in total. 

UNISoN trial scheme
 

HOW

do I get more information?

Information about the trial is available at www.anzup.org.au, via the ANZUP ClinTrial app, ANZCTR and clinicaltrials.gov.

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 

If you would like 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 a clinical trial for kidney cancer?