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A phase 1b dose-escalation and dose-expansion study of enfortumab vedotin (ASG-22CE) in combination with immune checkpoint inhibitor (CPI) therapy for treatment of patients with locally advanced or metastatic urothelial cancer

Clinical Trial Details

This clinical trial is for patients with locally advanced or metastatic urothelial cancer.

This is a study that will test how an experimental drug (enfortumab vedotin) combined with a kind of anticancer drug called an immune checkpoint inhibitor (CPI) affects patients with cancer of the urinary system (urothelial cancer). This type of cancer includes cancer of the bladder, renal pelvis, ureter or urethra that has spread to nearby tissues or to other areas of the body.
   
Patients will get the drugs twice every 21-day cycle. Patients will get enfortumab vedotin plus the CPI on day 1. Patients will get enfortumab vedotin only on day 8.
   
This study will look at the side effects of giving the two drugs with each other. A side effect is a response to a drug that is not part of the treatment effect. This study will also test if the cancer shrinks with treatment.

Key Eligibility: 
  • Adults 18 Years and older 
  • Diagnosis of locally advanced or metastatic urothelial cancer 
  • Eligible for CPI therapy and must be either ineligible for first-line cisplatin-based chemotherapy 
  • Detailed eligibility reviewed when you contact the study team. 

Contact

Lauren Gracey, RN
lae9024@med.cornell.edu
212-746-1480

Primary Investigator

Scott Tagawa, M.D.

Protocol ID(s)

Weill Cornell Medicine IRB #:

1708018482

ClinicalTrials.gov:

NCT03288545

Status:

Open to Enrollment

Age Group

Adult

Sponsor

Drug/Device

Drug

Study Type

Phase

1