header logo en

 

10 facts web



ADAPT (AGS-003)

 
A Phase III Trial of an Autologous Dendritic Cell Immunotherapy (AGS-003) Plus Standard Treatment of Advanced Renal Cell Carcinoma (RCC)
 
 Last updated:February 23, 2017
 STATUS: Stopped (not accepting new patients) (per ClinicalTrials.gov/NCT01582672)

WHO

is the trial for?

Patients with kidney cancer (Renal cell carcinoma, RCC) who currently meet the following criteria:
  • advanced and/or metastatic disease
  • predominantly clear cell histology
  • eligible for a standard first-line therapy with sunitinib
  • time from diagnosis to treatment less than 1 year
  • overall health status has to be good (Karnofsky performance status (KPS) ≥ 70%)

WHAT

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

This phase-III study seeks to clarify whether the new immunotherapies are superior to one of the standard therapies for kidney cancer.

This particular study investigates the combination of a human immunotherapy (called autologous dendritic cell immunotherapy) and sunitinib versus sunitinib alone in advanced renal cell carcinoma. For more information on autologous dendritic cell immunotherapy please read here.

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 has been stopped – approx. 450 patients worldwide are currently participating.

WHERE

is the trial available?

The trial is available in 125 cancer centers worldwide in 8 countries.
For a complete list of trial locations, please click here:
pdf List of study locations ADAPT (335 KB)
 

STUDY

DESIGN

What does the study look like?

There will be 2 study arms (groups): all participating patients will be randomly divided (by a computer) in two groups. Please note that patients in both groups will receive an active medication. No patient receives a placebo.

Patients in one group will be assigned the immunotherapy with AGS-003 in combination with sunitinib (SutentTM). Patients in the other group will be treated with sunitinib (SutentTM) alone, which is an approved treatment for RCC.
  • AGS-003 is a fully human immunotherapy
  • Sunitinib (Sutent™) is an oral, small-molecule, multi-targeted receptor tyrosine kinase inhibitor, already approved for the treatment of metastatic RCC
ADAPT trial
 
The combination of AGS-003 and sunitinib is given as follows:
1.) Sunitinib is taken by mouth once daily for 4 weeks then 2 weeks off.
2.) Intradermal injections of AGS-003 every 3 weeks for 5 doses then once every 12 weeks (= 8 injections in the 1st year followed by quarterly boosters).
3.) Plus sunitinib 4 weeks on, and 2 weeks off ongoing.
4.) Sunitinib alone is taken by mouth once daily for 4 weeks then 2 weeks off, continuously until documented disease progression, discontinuation due to toxicity or withdrawal of consent.

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.