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ADAPTeR

 
A Study of Anti-PD1 (Nivolumab) Therapy as Pre- and Post-operative Therapy in Metastatic Renal Cell Cancer
 
 Last updated: January 26, 2017
 STATUS: Open, recruiting (accepting new patients) (per ClinicalTrials.gov/NCT02446860)

WHO

is the trial for?

Patients with kidney cancer (Renal cell carcinoma, RCC) who currently meet the following criteria:
  • clear-cell component
  • metastatic disease (at least one site of disease outside the kidney)
  • scheduled to undergo nephrectomy as part of treatment plan
  • no prior systemic therapy for RCC
  • overall health status has to be good (ECOG 1 or 0)

WHAT

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

In metastatic RCC there is no standard drug therapy given before surgery, but such preoperative therapy is used widely in the treatment of other cancer types. This approach has several potential advantages including shrinking the tumour to help improve surgical outcomes and to help finding an appropriate drug therapy.

This phase II study seeks to clarify whether nivolumab could be a safe and effective preoperative treatment in RCC.

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) – 19 patients are currently expected to participate.

WHERE

is the trial available?

The trial will be available at The Royal Marsden NHS Foundation Trust London, United Kingdom.
Contact: Chloe McCormack
phone: 02078118085
e-mail: This email address is being protected from spambots. You need JavaScript enabled to view it.
 

STUDY

DESIGN

What does the study look like?

This is a single-arm study, therefore there will be only one group: all participating patients will receive the same medication, nivolumab:

• nivolumab (Opdivo™) is a fully human monoclonal antibody targeting PD-1

ADAPTeR

1.) All patients will receive nivolumab by intravenous infusion, given every two weeks for eight weeks prior to nephrectomy.

2.) Post-operatively nivolumab is again given every two weeks until patient is no longer deriving clinical benefit.

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.