Joint Clinical Trials Office

You are here

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 has a Dose Escalation group and a Dose Expansion group. The Expansion group is divided into 3 parts. Depending on what part of the study you are in, you will receive enfortumab vedotin plus other cancer fighting drugs. Your study doctor will let you know which part of the study that you will be in. 

If you are in Escalation or Part 1 of the study, we will treat you with enfortumab vedotin then pembrolizumab on Day 1 and with only enfortumab vedotin again on Day 8. 

If you are in Part 2 of the study, we will treat you with enfortumab vedotin then either cisplatin, carboplatin, or gemcitabine on Day 1. You will receive enfortumab vedotin again on Day 8. If you received gemcitabine on Day 1, you will receive it again on Day 8. 

If you are in Part 3 of the study, we will treat you with enfortumab vedotin followed by cisplatin or carboplatin, and then pembrolizumab on Day 1. You will receive only enfortumab vedotin again on Day 8. 

One year after you join the study, we will reduce the visits or phone calls to about every 12 weeks. 

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. 

Study contact by location

Upper East Side - Manhattan

Contact(s)

Amie Patel, RN
212-746-1480
amp3002@med.cornell.edu

Angela Tan, RN
212-746-4154
ant4009@med.cornell.edu

Primary Investigator(s)

Protocol ID(s)

Weill Cornell Medicine IRB #:

1708018482

ClinicalTrials.gov:

NCT03288545

Status

Open to Enrollment

Age Group

Adult

Sponsor