This phase II trial tests whether enfortumab vedotin works to shrink tumors in patients with castration-resistant prostate cancer that has spread to nearby tissue or lymph nodes (locally advanced), cannot be removed by surgery (unresectable), or has spread to other places in the body (metastatic). Enfortumab vedotin is a type of drug called an antibody drug conjugate or ADC. ADCs are designed to combine antibodies (part of the immune system) and a drug (in this case a chemotherapy drug) to help target and kill specific kinds of cell. Enfortumab vedotin has been designed to target and kill cancer cells.
Additional locations may be listed on ClinicalTrials.gov for NCT04754191.
Locations matching your search criteria
United States
Utah
Salt Lake City
Huntsman Cancer Institute/University of UtahStatus: Active
Contact: Umang Swami
Phone: 801-213-6147
PRIMARY OBJECTIVE:
I. To assess the anti-tumor action of the study therapy in subjects with metastatic castrate-resistant prostate cancer.
SECONDARY OBJECTIVES:
I. To assess the safety and tolerability of the study therapy in subjects with metastatic castrate-resistant prostate cancer.
II. To assess the efficacy of the study therapy in subjects with metastatic castrate-resistant prostate cancer.
EXPLORATORY OBJECTIVE:
I. To assess mechanisms of response, resistance, and disease progression in the study population.
OUTLINE:
Patients receive enfortumab vedotin intravenously (IV) over 30 minutes on days 1, 8, and 15. Cycles repeat every 28 days for up to 12 months in the absence of disease progression on unacceptable toxicity. Patients also undergo biopsy during screening, computed tomography (CT) or magnetic resonance imaging (MRI) and whole body bone scans throughout the trial, and collection of blood samples during screening and on study.
After completion of study completion, patients are followed up at 30 days, and then every 6 months for 2 years.
Lead OrganizationHuntsman Cancer Institute/University of Utah
Principal InvestigatorUmang Swami