Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at UC Irvine
Dates
study started
estimated completion

Description

Summary

This study will test a drug called enfortumab vedotin in participants with a type of bladder cancer called non-muscle invasive bladder cancer (NMIBC). This study will also evaluate what the side effects are and if the drug works to treat NMIBC. A side effect is anything a drug does to your body besides treating your disease. In this study enfortumab vedotin will be put into the bladder using a catheter. A catheter is a thin tube that can be put into your bladder.

Details

The study will comprise of 2 parts. The first part (dose escalation) will find the highest dose of enfortumab vedotin that does not cause unacceptable side effects in participants. The second part (dose expansion) will use the dose found in the first part to test how well the drug works. All participants will receive enfortumab vedotin. Treatment on the study will occur during the induction and maintenance phases, and participants will enter a follow-up period after completion of the maintenance phase.

Keywords

Urinary Bladder Neoplasms Carcinoma in Situ Carcinoma Transitional Cell Non-muscle Invasive Bladder Cancer NMIBC Bladder Cancer Urothelial Cancer Enfortumab vedotin PADCEV Pharmacokinetics Carcinoma Carcinoma, Transitional Cell

Eligibility

You can join if…

Open to people ages 18 years and up

  • Histologically confirmed, non-muscle invasive urothelial carcinoma with carcinoma in situ (CIS) (with or without papillary disease)
  • Predominant histologic component (>50 percent) must be urothelial (transitional cell) carcinoma
  • Participants must have high-risk Bacillus Calmette-Guerin (BCG) - unresponsive disease, defined as:
  • Persistent or recurrent CIS alone or with recurrent Ta/T1 disease within 12 months of completion of adequate BCG therapy. (Ta/T1: noninvasive papillary disease/tumor invades the subepithelial connective tissue). Adequate BCG therapy is defined as one of the following:
  • 5 of 6 doses of an initial induction course + at least 2 of 3 doses maintenance therapy
  • 5 of 6 doses of an initial induction course + at least 2 of 6 doses of a second induction course
  • Participant must be ineligible for or refusing a radical cystectomy
  • All visible papillary Ta/T1 tumors must be completely resected within 60 days prior to enrollment.
  • Eastern Cooperative Oncology Group Performance Status score of 0, 1, or 2.

You CAN'T join if...

  • Current or prior history of muscle-invasive urothelial carcinoma or metastatic disease.
  • Nodal or metastatic disease as noted on computed tomography (CT) or magnetic resonance imaging (MRI) within 3 months prior to study treatment
  • Concomitant upper tract urothelial carcinoma as noted on CT or MRI urogram performed within 3 months prior to study treatment
  • Prior or concomitant urothelial carcinoma of the prostatic urethra within 6 months prior to study treatment
  • Participants with tumor-related hydronephrosis
  • Participant has received other systemic anticancer therapy including chemotherapy, biologic therapy, immunotherapy, targeted therapy, endocrine therapy, and/or investigational agent within 4 weeks or intravesical therapy within 6 weeks of first dose of study treatment
  • Subject has had any prior radiation to the bladder for urothelial cancer

Locations

  • University of California, Irvine accepting new patients
    Orange California 92868 United States
  • MD Anderson accepting new patients
    Houston Texas 77030 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Astellas Pharma Global Development, Inc.
ID
NCT05014139
Phase
Phase 1 research study
Study Type
Interventional
Participants
Expecting 58 study participants
Last Updated