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A Study of Disitamab Vedotin Alone or With Pembrolizumab in Urothelial Cancer That Expresses HER2

NCT04879329 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 372

Last updated 2026-04-21

No results posted yet for this study

Summary

This study is being done to see if a drug called disitamab vedotin, alone or with pembrolizumab, works to treat HER2 expressing urothelial cancer. It will also test how safe the drug is for participants.

Participants will have cancer that has spread in the body near where it started (locally advanced) and cannot be removed (unresectable) or has spread through the body (metastatic).

It will also study what side effects happen when participants get the drug. A side effect is anything a drug does to your body besides treating the disease.

Conditions

Interventions

DRUG

disitamab vedotin

Given into the vein (IV; intravenous) every 2 weeks.

DRUG

pembrolizumab

Given by IV on Day 1 of each 6-week cycle.

Sponsors & Collaborators

Principal Investigators

  • Pfizer CT.gov Call Center · Pfizer

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-05-03
Primary Completion
2026-12-11
Completion
2029-04-14
FDA Drug
Yes

Countries

  • United States
  • Argentina
  • Australia
  • Belgium
  • Canada
  • Chile
  • Israel
  • Italy
  • Japan
  • Spain
  • Turkey (Türkiye)
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04879329 on ClinicalTrials.gov