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Looking for participantsPhase1/Phase2

A Substudy of Investigational Agents in Programmed Cell Death-1/Ligand 1 (PD-1/L1) Refractory Locally Advanced or Metastatic Urothelial Carcinoma (mUC) (MK-3475-04A)

Sponsor: Merck Sharp & Dohme LLC

NCT ID: NCT05562830

View on ClinicalTrials.gov ↗

At a glance

What the study gets you
Access to the study treatment being tested
Type of study
Interventional (receives a drug or procedure)
Time in hospital
In-person visits at study sites — visit count not specified by the sponsor
Drug or intervention
Zilovertamab vedotin (biological), Pembrolizumab (biological), MK-3120 (biological)
How long the study runs
Study runs about 75 months (dates as stated)
About the drug or intervention
Zilovertamab vedotin — biological: Administered via intravenous (IV) infusion on day 1 and day 8 of Q3W cycles · Pembrolizumab — biological: Administered via IV infusion on Day 1 of each 6 week cycle. · MK-3120 — biological: Administered as an IV infusion on Day 1, Day 15, and Day 29 of each 6 week cycle.
Patient visit burden
Not specified by the sponsor
Type of study
Testing a treatment
Ages
18 Years and over
Who
All
Number of participants
48
Started
2022-11-16
Last checked
2026-09

Plain English Summary

What is this study?

  • • Testing a new treatment for urothelial carcinoma
  • • Phase1/Phase2 - 48 participants
  • • 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

Who can take part?

  • • Ages 18 Years and over
  • • Diagnosed with urothelial carcinoma

Where?

  • • London - St Bartholomew's Hospital ( Site 1206)
  • • London - ROYAL MARSDEN HOSPITAL (CHELSEA) ( Site 1201)

This is a simplified summary. Always discuss with your doctor before making any decisions.

About This Trial

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.

Urothelial Carcinoma

How this trial compares with your answers

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What we know so far

Condition· Matched your search
Age· Tell us your age for better matching
Gender· Tell us your sex for better matching

Still need:

  • • Tell us your age for better matching
  • • Tell us your sex for better matching

Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.

Eligibility at a Glance

Key info

  • Age: 18 Years and over
  • Who can join: All genders

What the study is looking for

  • ✓The main inclusion and exclusion criteria include but are not limited to the following:
  • ✓confirmed by testing a sample diagnosis of that has grown locally/unresectable or mUC of the kidney pelvis,...

Who cannot take part

  • ✗Known additional nonurothelial cancer that is progressing or has required active treatment within 3 years prior...
  • ✗Received prior systemic anticancer therapy including investigational agents within 4 weeks before...
  • ✗Active infection requiring treatment that goes through your whole body.
  • ✗Received a live or live-attenuated vaccine within 30 days before the first dose of study intervention....
  • ✗Known history of human immunodeficiency virus (HIV).
See the full criteria
Inclusion Criteria: The main inclusion and exclusion criteria include but are not limited to the following: * Histologically or cytologically confirmed diagnosis of locally advanced/unresectable or mUC of the renal pelvis, ureter (upper urinary tract), bladder, or urethra. * Arm A: PD-1/L1 refractory locally advanced or mUC as evidenced by: EITHER disease progression while on treatment or after treatment with an anti-PD-1/L1 monoclonal antibody (mAb) for locally advanced/unresectable or mUC administered either as monotherapy, or in combination with other checkpoint inhibitors or other therapies OR disease recurrence while on treatment or after treatment with an anti-PD-1/L1 mAb for muscle-invasive urothelial carcinoma (MIUC) administered as monotherapy. * Arm A: Participants must provide an archival tumor tissue sample or newly obtained core or excisional biopsy of a tumor lesion demonstrating UC, not previously irradiated, and adequate for biomarker evaluation. * Arm B: PD-1/L1 refractory locally advanced or mUC as evidenced by: EITHER disease progression after treatment with an anti-PD-1/L1 mAb for locally advanced/unresectable or mUC administered either as monotherapy, or in combination with other checkpoint inhibitors or other therapies; OR disease recurrence after treatment with an anti-PD-1/L1 mAb for MIUC administered as monotherapy or in combination with other checkpoint therapies \>12 months after last dose of treatment with an anti-PD-1/L1 mAb. * Arm B: Participants must provide an archival tumor tissue sample or newly obtained core or excisional biopsy of a tumor lesion from a metastatic site or from a primary tumor that has become locally advanced and not previously irradiated. Exclusion Criteria: * Known additional nonurothelial malignancy that is progressing or has required active treatment within 3 years prior to study randomization/allocation. * Received prior systemic anticancer therapy including investigational agents within 4 weeks before randomization/allocation. * Active infection requiring systemic therapy. * Received a live or live-attenuated vaccine within 30 days before the first dose of study intervention. Administration of killed vaccines are allowed. * Known history of human immunodeficiency virus (HIV). * Known history of hepatitis B or known hepatitis C virus infection.

Where Is This Study? (2 UK sites)

St Bartholomew's Hospital ( Site 1206)

London EC1A 7BE, United Kingdom

Recruiting
Site contact (verified)
Study Coordinator+44 0203 416 5000

ROYAL MARSDEN HOSPITAL (CHELSEA) ( Site 1201)

London SW3 6JJ, United Kingdom

Recruiting
Site contact (verified)
Study Coordinator+44 20 7352 8171

How to Get in Touch

Toll Free Number

Sponsor contact

CONTACT

1-888-577-8839 Trialsites@msd.com
Data sourced from ClinicalTrials.gov · Last verified: 2026-09