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ACTIVE NOT RECRUITING Phase 3

Disitamab Vedotin With Pembrolizumab vs Chemotherapy in Previously Untreated Urothelial Cancer Expressing HER2

NCT05911295 · View on ClinicalTrials.gov ↗

Study Summary

This study will enroll participants with urothelial cancer (UC). UC can include cancer of the bladder, kidney, or the tubes that carry pee through the body (ureter, urethra). This study will try to find out if the drugs disitamab vedotin with pembrolizumab works better than platinum-containing chemotherapy to treat patients with UC. This study will also test what side effects happen when participants take these drugs together. A side effect is anything a drug does to the body besides treating the disease. Participants in this study will have cancer that has spread through the body (metastatic) or spread near where it started (locally advanced). In this study, there are 2 different groups. Participants will be assigned to a group randomly. Participants in the disitamab vedotin arm will get the study drug disitamab vedotin once every two weeks and pembrolizumab once every 6 weeks. Participants in the standard of care arm will get gemcitabine once a week for 2 weeks with either cisplatin or carboplatin once every 3 weeks.

Conditions Studied

Interventions

  • DRUG pembrolizumab
  • DRUG disitamab vedotin
  • DRUG cisplatin
  • DRUG carboplatin
  • DRUG gemcitabine

Study Locations (20)

California

  • UCLA Hematology/Oncology - Alhambra — Alhambra
  • Foothill Cardioology — Arcadia
  • Beverly Hills Multi-Specialties Practice — Beverly Hills
  • Providence Saint Joseph Medical Center — Burbank
  • UCLA Burbank Cardiology — Burbank
  • UCLA Hematology/Oncology - Burbank — Burbank
  • UCLA Calabasas Specialty Care — Calabasas
  • UCLA Encino Specialty Care (Radiology) — Encino
  • UCLA Hematology/Oncology - Encino — Encino
  • Helios Clinical Research — Fountain Valley
  • Helios Clinical Research — Glendale
  • Foothill Cardiology Glendora — Glendora
  • Helios Clinical Research — Long Beach
  • UCLA Downtown Los Angeles Primary & Specialty Care — Los Angeles
  • UCLA Cardiovascular Center — Los Angeles
  • UCLA Department of Medicine-Hematology/Oncology — Los Angeles
  • UCLA Hematology & Oncology Clinic — Los Angeles
  • UCLA Hematology / Oncology — Los Angeles

Arizona

  • Banner Gateway Medical Center — Gilbert
  • Banner MD Anderson Cancer Center — Gilbert

Trial Details

FieldValue
Enrollment Target 412 participants
Start Date 2023-09-22
Est. Completion 2029-04-30
Phase Phase 3

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT05911295

The ClinicalTrials.gov registry entry for NCT05911295 describes a study currently listed as active not recruiting. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 412 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Seagen, a wholly owned subsidiary of Pfizer, which has 51 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 1 condition, with Urothelial Carcinoma appearing as the primary indexed condition, and to 5 interventions — of which pembrolizumab is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT05911295 reports 20 study locations spanning 2 distinct geographic areas — top geographies include California, Arizona. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT05911295 about?

NCT05911295 is a clinical study titled "Disitamab Vedotin With Pembrolizumab vs Chemotherapy in Previously Untreated Urothelial Cancer Expressing HER2". This study will enroll participants with urothelial cancer (UC). UC can include cancer of the bladder, kidney, or the tubes that carry pee through the body (ureter, urethra). This study will try to find out if the drugs disitamab vedotin with pembrolizumab works better than platinum-containing chemo...

What is the current status of trial NCT05911295?

This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 412 participants. The study started on 2023-09-22. Estimated completion is 2029-04-30.

What conditions does trial NCT05911295 study?

This clinical trial studies the following conditions: Urothelial Carcinoma. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT05911295?

The interventions under investigation include: pembrolizumab (DRUG), disitamab vedotin (DRUG), cisplatin (DRUG), carboplatin (DRUG), gemcitabine (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT05911295?

This trial is sponsored by Seagen, a wholly owned subsidiary of Pfizer, which has 51 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT05911295 being conducted?

This trial has 20 study locations across Arizona, California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial