Trial Purpose

This study is a sub-study being conducted under one pembrolizumab umbrella master study KEYMAKER-U04. The sub-study will consist of 2 parts. Part 1 will evaluate the efficacy and safety of coformulated favezelimab/pembrolizumab plus EV and coformulated vibostolimab/pembrolizumab plus EV relative to pembrolizumab plus EV. There will be no comparison of coformulated favezelimab/pembrolizumab plus EV versus coformulated vibostolimab/pembrolizumab plus EV. If ORR and/or DRR are substantially better on coformulated favezelimab/pembrolizumab plus EV and/or coformulated vibostolimab/pembrolizumab plus EV compared with pembrolizumab plus EV, after evaluation of the totality of data, the sponsor might consider Part 2 (expansion) to further characterise the efficacy and safety of the treatment arms under study.

View full trial information on Clinicaltrials.gov

NATIONAL TRIAL REFERENCE NUMBER

NCT05845814

EudraCT

2022-001371-14

When speaking to your doctor or clinical trial representative, please have the trial reference number available.

Resources

Eligibility

Only a qualified healthcare professional can determine if you are eligible to take part in a clinical trial. However, this information may be useful in starting a conversation with your doctor.

Conditions Icon

Conditions

Metastatic Urothelial Carcinoma, Urothelial Neoplasms

Age Range Icon

Age Range

18+

Sex Icon

Sex

All

About The Trial

Trial phase Icon Trial Phase

Trial Phase 1

Tests the medicine or vaccine in a small group of 20 to 100 volunteers who are usually healthy, but not always. The trial often takes place in a hospital.

Trial Phase 2

Tests the medicine or vaccine in approximately 100 to 500 volunteers. In the case of medicines, volunteers usually have the disease or condition the investigational medicine is designed to treat. In vaccine studies, the volunteers are usually healthy.

Trial start Icon Trial start and end dates
  • Actual study start date 23 June 2023
  • Estimated primary completion date 31 May 2027
  • Estimated study completion date 31 May 2027

Trial locations

Locations shown may have changed in some cases. Please call the number listed in the location results to confirm the nearest trial site. Talk with a trial site member for more information.

What can you do next?

If you think this clinical trial might be a good fit and you are interested in taking part, take the next step to see if you are eligible.

Discuss with your doctor or care team

Print this page with details about the trial or email it to your doctor to discuss the clinical trial during your next visit.

Get help talking with your doctor or care team

NATIONAL TRIAL REFERENCE NUMBER

NCT05845814

EudraCT

2022-001371-14

When speaking to your doctor or clinical trial representative, please have the trial reference number available.

Taking part in a clinical trial is an important decision

If you are considering joining a clinical trial, first learn as much as you can about:

  • The investigational treatment that is being studied
  • What the risks and possible benefits are for participants

Talk to your doctor about the clinical trial before you decide to join.

Read our “What to Consider” page for more questions to ask and think about