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A Study of Intravesical Enfortumab Vedotin For Treatment of Patients With Non-muscle Invasive Bladder Cancer (NMIBC)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05014139
Recruitment Status : Recruiting
First Posted : August 20, 2021
Last Update Posted : May 3, 2023
Sponsor:
Collaborator:
Seagen Inc.
Information provided by (Responsible Party):
Astellas Pharma Inc ( Astellas Pharma Global Development, Inc. )

Study Description
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Brief 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.


Condition or disease Intervention/treatment Phase
Urinary Bladder Neoplasms Carcinoma in Situ Carcinoma Transitional Cell Non-muscle Invasive Bladder Cancer NMIBC Drug: Enfortumab vedotin Phase 1

Detailed Description:

The study will be comprised 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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 58 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Study of Intravesical Enfortumab Vedotin For Treatment of Patients With Non-muscle Invasive Bladder Cancer (NMIBC)
Actual Study Start Date : December 7, 2021
Estimated Primary Completion Date : June 30, 2024
Estimated Study Completion Date : May 31, 2028

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bladder Cancer

Arms and Interventions
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Arm Intervention/treatment
Experimental: Enfortumab vedotin: Dose escalation cohort
During the induction phase, participants will receive enfortumab vedotin once a week for 6 weeks. During the maintenance phase, participants will receive enfortumab vedotin once a month for 9 doses.
 Drug: Enfortumab vedotin
Given into the bladder (intravesically)
Other Name: PADCEV, ASG-22CE, ASG-22ME
Experimental: Enfortumab vedotin: Dose expansion cohort
During the induction phase, participants will receive enfortumab vedotin once a week for 6 weeks. During the maintenance phase, participants will receive enfortumab vedotin once a month for 9 doses.
 Drug: Enfortumab vedotin
Given into the bladder (intravesically)
Other Name: PADCEV, ASG-22CE, ASG-22ME


Outcome Measures
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Primary Outcome Measures :
  1. Incidence of adverse events (AEs) [ Time Frame: Approximately 1 year ]
    An AE is any untoward medical occurrence in a subject or clinical investigational subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment.

  2. Incidence of laboratory abnormalities [ Time Frame: Approximately 1 year ]
    To be summarized using descriptive statistics.

  3. Incidence of dose limiting toxicities (DLTs) [ Time Frame: Approximately 7 weeks ]
    To be summarized using descriptive statistics.


Secondary Outcome Measures :
  1. Pharmacokinetics (PK) of enfortumab vedotin: Area under the concentration-time curve (AUC) [ Time Frame: Approximately 1 year ]
    AUC will be recorded from the PK blood samples collected.

  2. PK of enfortumab vedotin: Maximum concentration (Cmax) [ Time Frame: Approximately 1 year ]
    Cmax will be recorded from the PK blood samples collected.

  3. PK of enfortumab vedotin: Time to maximum concentration concentration (tmax) [ Time Frame: Approximately 1 year ]
    Tmax will be recorded from the PK blood samples collected.

  4. PK of enfortumab vedotin: Apparent terminal half-life (t1/2) [ Time Frame: Approximately 1 year ]
    T1/2 will be recorded from the PK blood samples collected.

  5. PK of enfortumab vedotin: Trough concentration (Ctrough) [ Time Frame: Approximately 1 year ]
    Ctrough will be recorded from the PK blood samples collected.

  6. Incidence of antitherapeutic antibodies (ATAs) to enfortumab vedotin [ Time Frame: Approximately 1 year ]
    Blood samples for ATA analysis will be collected.

  7. Complete response (CR) rate [ Time Frame: Up to 24 months ]
    CR rate is defined as the proportion of subjects achieving CR.

  8. Duration of CR [ Time Frame: Up to 5 years ]
    The time from first documented CR to the first evidence of recurrence, progression, or death due to any cause.

  9. Rate of cystectomy [ Time Frame: Up to 5 years ]
    The proportion of subjects who subsequently undergo cystectomy.

  10. Progression-free survival [ Time Frame: Up to 5 years ]
    The time from start of study treatment to the first evidence of progression or death due to any cause.

  11. Cystectomy-free survival [ Time Frame: Up to 5 years ]
    The time from start of study treatment to cystectomy or death due to any cause.


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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 (where 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 or 5 of 6 doses of an initial induction course + at least 2 of 6 doses of a second induction course):

    • Persistent or recurrent CIS alone or with recurrent Ta/T1 (noninvasive papillary disease/tumor invades the subepithelial connective tissue) disease within 12 months of completion of adequate BCG therapy.
    • Recurrent high-grade Ta/T1 disease within 6 months of completion of adequate BCG therapy, or
    • T1 high-grade disease at the first evaluation following an induction BCG course (at least 5 or 6 doses)
  • 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.

Exclusion Criteria:

  • 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
  • Participant has had any prior radiation to the bladder for urothelial cancer
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05014139


Contacts
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Contact: Seagen, Inc. Trial Information Support 866-333-7436 clinicaltrials@seagen.com

Locations
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United States, California
University of California, Irvine Recruiting
Orange, California, United States, 92868
University of California at San Francisco Recruiting
San Francisco, California, United States, 94134
United States, Maryland
Johns Hopkins Medical Center Recruiting
Baltimore, Maryland, United States, 21287
United States, New York
Laura & Isaac Perlmutter Cancer Center at NYU Langone Health Completed
New York, New York, United States, 10016
United States, North Carolina
Duke University Medical Center Recruiting
Durham, North Carolina, United States, 27710
United States, Texas
University of Texas Southwestern Medical Center Recruiting
Dallas, Texas, United States, 75390
MD Anderson Recruiting
Houston, Texas, United States, 77030
Canada, Ontario
Site CA11001 Recruiting
Toronto, Ontario, Canada, M5G 2C1
France
Site FR33001 Recruiting
Paris, France, 75013
Spain
Site ES34001 Recruiting
Barcelona, Spain, 08025
Site ES34003 Recruiting
Barcelona, Spain, 08036
Site ES34002 Recruiting
Madrid, Spain, 28041
United Kingdom
Site UK44002 Recruiting
London, United Kingdom, EC1A 7BE
Sponsors and Collaborators
Astellas Pharma Global Development, Inc.
Seagen Inc.
Investigators
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Study Director: Janet Trowbridge, MD Seagen Inc.
More Information
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Responsible Party: Astellas Pharma Global Development, Inc.
ClinicalTrials.gov Identifier: NCT05014139    
Other Study ID Numbers: SGN22E-004
EV-104 ( Other Identifier: Seagen, Inc. )
First Posted: August 20, 2021    Key Record Dates
Last Update Posted: May 3, 2023
Last Verified: May 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Astellas Pharma Inc ( Astellas Pharma Global Development, Inc. ):
Bladder Cancer
Urothelial Cancer
Enfortumab vedotin
PADCEV
Pharmacokinetics
Additional relevant MeSH terms:
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Carcinoma
Urinary Bladder Neoplasms
Carcinoma in Situ
Non-Muscle Invasive Bladder Neoplasms
Carcinoma, Transitional Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Urologic Neoplasms
 Urogenital Neoplasms
Neoplasms by Site
Female Urogenital Diseases
Female Urogenital Diseases and Pregnancy Complications
Urogenital Diseases
Urinary Bladder Diseases
Urologic Diseases
Male Urogenital Diseases