A study of enfortumab vedotin (ASG-22CE) as monotherapy or in combination with other anticancer therapies for the treatment of urothelial cancer

About this Study

To assess the antitumor activity of neoadjuvant enfortumab vedotin monotherapy or enfortumab vedotin in combination with pembrolizumab as measured by the pathological complete response (herein referred to as either pT0 or pCR) rate by local pathology review in patients with T2-T4aN0M0 muscle invasive bladder
cancer

Sponsor Protocol ID:pending
IRB Number:2020V077
Pending Activation
Interventional
Phase 1
December 21, 2020
Eligibility Criteria
18 years old
Both Male and Female
Yes
No
No

Inclusion Criteria1.  Minimum age of 18 years 

2.  Anticipated life expectancy of ≥3 months as assessed by the investigator.

If of childbearing potential:

 i. Agree not to try to become pregnant during the study and for at least 6 months after the final study drug administration, 

ii. And have a negative urine or serum pregnancy test within 3 days prior to Day 1 (Females with false positive results and documented verification of negative pregnancy status are eligible for participation), 

iii. And if heterosexually active, agree to abstinence (if in line with the usual preferred lifestyle of the patient) or consistently use a condom plus 1 form of highly effective birth control (see note † below) per locally accepted standards starting at screening and throughout the study period and for at least 6 months after the final study drug administration. 

3. Female patient must agree not to breastfeed or donate ova starting at screening and throughout the study period, and for at least 6 months after the final study drug administration. 

4. A sexually active male patient with female partner(s) who are of childbearing potential is eligible if: 

 Agree to abstinence (if in line with the usual preferred lifestyle of the patient) or to use a male condom starting at screening and continue throughout study treatment and for at least 6 months after the final study drug administration. If the male patient has not had a vasectomy or is not sterile as defined below their female partner(s) is utilizing 1 form of highly effective birth control (see note † below) per locally accepted standards starting at screening and continuing throughout study treatment and for at least 6 months after the male patient receives their final study drug administration

Exclusion Criteria1.   Patients with conditions requiring high doses of steroids (>10 mg/day of prednisone or equivalent) or other immunosuppressive medications are excluded. Inhaled or topical steroids are permitted in the absence of active autoimmune disease

2.  History of another malignancy within 3 years before the first dose of study drug,

3.  Currently receiving systemic antimicrobial treatment for active infection (viral, bacterial, or fungal) at the time of first dose of enfortumab vedotin. Routine antimicrobial prophylaxis is permitted.

4.  Patients with a positive hepatitis B surface antigen and/or antihepatitis B core antibody

5.  Active hepatitis C infection or known human immunodeficiency virus (HIV) infection.

6.  Documented history of a cerebral vascular event (stroke or transient ischemic attack)

7.  Patients with active tuberculosis

Categories Click category to view its trials.
Cancer
Participating Locations
Cancer Center and Research Institute
University Hospital
Contact Information
Contact Name: Jennifer Barnes
Email: jbarnes@umc.edu
Principal Investigator:Henegan, John C, M.D.
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