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

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.

Trial Details

NCT ID
NCT04879329
Phase
PHASE2
Sponsor
Seagen, a wholly owned subsidiary of Pfizer
Status
RECRUITING
Cancer Type
Urothelial Carcinoma Bladder Cancer
Interventions
  • disitamab vedotin
  • pembrolizumab
Locations (sample)
  • Gilbert, Arizona, United States|33.35283,-111.78903
  • Anaheim, California, United States|33.83529,-117.9145
  • Pasadena, California, United States|34.14778,-118.14452
  • Washington D.C., District of Columbia, United States|38.89511,-77.03637
  • Bonita Springs, Florida, United States|26.33981,-81.7787

Key Eligibility Criteria

  • Cohorts A and B
  • Histopathologically-confirmed, locally-advanced, unresectable or metastatic urothelial cancer (LA/mUC), including UC originating from the renal pel…
  • Participants must have received only 1 or 2 lines of prior systemic treatment for LA/mUC, including 1 line of platinum-containing chemotherapy
  • At least one measurable lesion by investigator assessment based on RECIST version 1.1.

For full eligibility, visit ClinicalTrials.gov.

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