Ask to take part

Contact the study team using the details below to take part. If there are no contact details below please ask your doctor in the first instance.

Contact Information:

Study Location:

Find another location


Questions to ask
Skip to Main Content
English | Cymraeg
Be Part of Research - Trial Details - Perioperative Pembrolizumab (MK-3475) Plus Cystectomy or Perioperative Pembrolizumab Plus Enfortumab Vedotin Plus Cystectomy Versus Cystectomy Alone in Participants Who Are Cisplatin-ineligible or Decline Cisplatin With Muscle-invasive Bladder Cancer (MK-3475-905/KEYNOTE-905/EV-303)
Back

Perioperative Pembrolizumab (MK-3475) Plus Cystectomy or Perioperative Pembrolizumab Plus Enfortumab Vedotin Plus Cystectomy Versus Cystectomy Alone in Participants Who Are Cisplatin-ineligible or Decline Cisplatin With Muscle-invasive Bladder Cancer (MK-3475-905/KEYNOTE-905/EV-303)

Not Recruiting

Open to: ALL

Age: 18.0 - N/A

Canterbury Middlesbrough Stevenage London London London Truro Wirral Edinburgh Walsall

Medical Conditions

Urinary Bladder Neoplasms
Muscle Neoplasms

This information is provided directly by researchers, and we recognise that it isn't always easy to understand. We are working with researchers to improve the accessibility of this information. In some summaries, you may come across links to external websites. These websites will have more information to help you better understand the study.


This is a study of perioperative pembrolizumab or enfortumab vedotin in combination with pembrolizumab in participants who are cisplatin-ineligible or decline cisplatin with muscle-invasive bladder cancer (MIBC).

The primary hypothesis is that perioperative pembrolizumab plus radical cystectomy (RC) plus pelvic lymph node dissection (PLND) and perioperative enfortumab vedotin in combination with pembrolizumab plus RC+PLND will achieve superior event-free survival (EFS) compared with RC+PLND alone.

With Amendment 5, outcome measures for programmed cell death ligand 1 (PD-L1) combined positive score (CPS) were removed.

With Amendment 8, the primary outcome measure of pathologic complete response (pCR) rates was changed to a secondary outcome measure.

Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.  

The recruitment start and end dates are as follows:

Jul 2019 May 2027

Publications

"Galsky MD, Hoimes CJ, Necchi A, Shore N, Witjes JA, Steinberg G, Bedke J, Nishiyama H, Fang X, Kataria R, Sbar E, Jia X, Siefker-Radtke A. Perioperative pembrolizumab therapy in muscle-invasive bladder cancer: Phase III KEYNOTE-866 and KEYNOTE-905/EV-303. Future Oncol. 2021 Aug;17(24):3137-3150. doi: 10.2217/fon-2021-0273. Epub 2021 May 19."; "34008425"

INTERVENTIONAL

Intervention Type : DRUG
Intervention Description : Pembrolizumab 200 mg by intravenous (IV) infusion, given on Day 1 of each 21-day cycle.

Intervention Arm Group : Arm A: Pembrolizumab + Surgery;

Intervention Type : PROCEDURE
Intervention Description : Surgical RC+PLND will be done in accordance with the American Urological Association (AUA)/American Society of Clinical Oncology (ASCO)/American Society for Radiation Oncology (ASTRO)/Society of Urologic Oncology (SUO) guidelines.

Intervention Arm Group : Arm A: Pembrolizumab + Surgery;Arm B: Surgery alone;

Intervention Type : DRUG
Intervention Description : Enfortumab vedotin 1.25 mg/kg by intravenous (IV) infusion, given on Days 1 and 8 of each 21-day cycle.

Intervention Arm Group : Arm C: Enfortumab Vedotin + Pembrolizumab + Surgery;



You can take part if:



You may not be able to take part if:


This is in the inclusion criteria above


Below are the locations for where you can take part in the trial. Please note that not all sites may be open.

  • Kent and Canterbury Hospital ( Site 0733)
    Canterbury
    England
    CT1 3NG
  • The James Cook University Hospital ( Site 0730)
    Middlesbrough
    England
    TS4 3BW
  • Lister Hospital ( Site 0739)
    Stevenage
    Hertfordshire
    SG1 4AB
  • Barts Health NHS Trust - St Bartholomew s Hospital ( Site 0725)
    London
    London, City Of
    EC1A 7BE
  • The Royal Marsden Foundation Trust ( Site 0726)
    London
    London, City Of
    SW3 6JJ
  • Imperial College Healthcare NHS Trust ( Site 0745)
    London
    London, City Of
    W6 8RF
  • Royal Cornwall Hospital ( Site 0727)
    Truro
    TR1 3LJ
  • Clatterbridge Oncology Centre ( Site 0731)
    Wirral
    CH63 4JY
  • Western General Hospital ( Site 0749)
    Edinburgh
    Midlothian
    EH4 2XU
  • Walsall Manor Hospital-Oncology ( Site 0743)
    Walsall
    WS2 9PS


The study is sponsored by Merck Sharp & Dohme LLC and is in collaboration with Seagen Inc.; Astellas Pharma Global Development, Inc..



We'd like your feedback

Your feedback is important to us. It will help us improve the quality of the study information on this site. Please answer both questions.


Is this study information helpful?

What will you do next?
Read full details for Trial ID: NCT03924895
Last updated 27 January 2025

This page is to help you find out about a research study and if you may be able to take part

You can print or share the study information with your GP/healthcare provider or contact the research team directly.   

Back to the top