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

Purpose

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).

Contact

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

Protocol
22-409
Phase
Phase II (phase 2)
Disease Status
Newly Diagnosed & Relapsed/Refractory
Investigator
Co-Investigators
ClinicalTrials.gov ID
NCT04879329