A Phase 2 Study of Disitamab Vedotin Alone and with Pembrolizumab Immunotherapy in People with Inoperable or Metastatic Urothelial Cancer


Full Title

A Phase 2 Multi-Cohort, Open-Label, Multi-Center Clinical Study Evaluating the Efficacy and Safety of Disitamab Vedotin (RC48-ADC) Alone or in Combination with Pembrolizumab in Subjects with Locally-Advanced Unresectable or Metastatic Urothelial Carcinoma That Expresses HER2


In this study, researchers are assessing the safety and effectiveness of giving the drug disitamab vedotin alone and in combination with pembrolizumab immunotherapy in people with inoperable or metastatic urothelial cancers that make too much of the HER2 protein. Disitamab vedotin targets and kills cancer cells with the HER2 protein. Pembrolizumab boosts the power of the immune system to detect and destroy cancer cells.

Participants who have had treatment for their cancer before and who experienced continued cancer growth will receive disitamab vedotin alone. Those who have not yet received cancer therapy will receive disitamab vedotin in combination with pembrolizumab. Both medications are given intravenously (by vein).

Who Can Join

To be eligible for this study, patients must meet several requirements, including:

  • Participants must have HER2-positive inoperable or metastatic urothelial cancer.
  • Patients who received prior therapy may not have had more than two previous regimens of treatment and must have experience continued cancer growth. At least 2 weeks must pass between the completion of prior therapy and receipt of the study treatment.
  • Patients must be physically well enough that they are able to be mobile, take care of themselves, and engage in all but physically strenuous activities. For example, they must be well enough that they could carry out office work or light housework.
  • This study is for people age 18 and older.


For more information and to ask about eligibility for this study, please contact the office of Dr. Gopakumar Iyer at 646-888-4737.




Phase II (phase 2)

Disease Status

Newly Diagnosed & Relapsed/Refractory



ClinicalTrials.gov ID