Trial Purpose

This substudy is part of an umbrella platform study which is designed to evaluate investigational agents with or without pembrolizumab in participants with urothelial carcinoma who are in need of new treatment options. Substudy 04A will enroll participants with locally advanced or mUC whose disease is resistant to treatment with programmed cell death-1/ligand 1 (PD-1/L1) inhibitors. The protocol infrastructure will enable the rolling assignment of investigational treatments.

View full trial information on Clinicaltrials.gov

CLINICALTRIALS.GOV IDENTIFIER:

NCT05562830

When speaking to your doctor, please have the trial identifier number available.

About The Trial

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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.

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.

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Dates

  • Actual study start date November 16, 2022
  • Estimated primary completion date October 28, 2027
  • Estimated study completion date October 28, 2027

Eligibility

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Conditions

Urothelial Carcinoma

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Age Range

18 - No Age Maximum

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Sex

All

Trial locations

What Can You Do Next?

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

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Discuss With Your Doctor

Print this page or email it to your doctor to discuss at your next visit.

CLINICALTRIALS.GOV IDENTIFIER:

NCT05562830

When speaking to your doctor, please have the trial identifier number available.

Participating in a clinical trial is an important decision.

Anyone participating in a trial should know as much as possible about what is being studied, what risks are involved and what potential benefits may be gained before deciding to enroll. If you are interested in participating in a clinical trial, please talk to your doctor first.