Study on Disitamab Vedotin with Pembrolizumab vs Chemotherapy for Untreated Urothelial Cancer with HER2 Expression

Sponsor: Seagen Inc.

Sponsor score: 60
Inactive

ClinicalTrials ID:NCT05911295

Provider View

This clinical trial is comparing a new treatment using disitamab vedotin and pembrolizumab against standard chemotherapy for patients with urothelial cancer that has not been treated before. The study aims to see which treatment works better and to understand the side effects of the new drug combination.

Patient Parameters

Program Overview

This study is for people with urothelial cancer, which can affect the bladder, kidneys, or the tubes that carry urine. The cancer must have spread either throughout the body or near its original location. The trial will compare two treatments: one group will receive disitamab vedotin and pembrolizumab, while the other group will receive standard chemotherapy with gemcitabine and either cisplatin or carboplatin. Participants will be randomly assigned to one of these groups. The study will also monitor any side effects from the treatments.

Eligibility Criteria

Inclusion Criteria

  • Have a confirmed diagnosis of advanced urothelial cancer that cannot be removed by surgery or has spread to other parts of the body.
  • Have measurable cancer as determined by medical scans.
  • Have not received previous treatment for advanced urothelial cancer, except if the cancer returned more than 12 months after finishing earlier treatments.
  • Be eligible to receive chemotherapy with cisplatin or carboplatin.
  • Be able to provide a sample of the cancer tissue from a previous surgery or biopsy.
  • Have a HER2 protein level of 1+ or higher in the cancer cells.
  • Have a performance status score of 0, 1, or 2, indicating the ability to carry out daily activities with some limitations.

Exclusion Criteria

  • Have an allergy to any of the study drugs or their components.
  • Have had severe immune-related side effects from similar treatments in the past.
  • Have cancer that has spread to the brain or spinal cord, unless it has been stable for at least 4 weeks and is not worsening.
  • Have an autoimmune disease that needed treatment in the last 2 years.
  • Have had previous treatments targeting specific immune cell receptors.
  • Have had a solid organ or bone marrow transplant.
  • Have fluid buildup in the chest or abdomen that causes symptoms or needs treatment.
  • Have a life expectancy of less than 12 weeks.
  • Have had previous treatments with certain types of cancer drugs targeting HER2 or similar agents.

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