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Active, not recruiting Phase 2 Interventional Results available

A Study of TAR-200 in Combination With Cetrelimab, TAR-200 Alone, or Cetrelimab Alone in Participants With Non-Muscle Invasive Bladder Cancer (NMIBC) Unresponsive to Intravesical Bacillus Calmette-Guérin Who Are Ineligible for or Elected Not to Undergo Radical Cystectomy

ClinicalTrials.gov ID: NCT04640623

Public ClinicalTrials.gov record NCT04640623. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Oct 21, 2026, 6:29 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

Phase 2b Clinical Study Evaluating Efficacy and Safety of TAR-200 in Combination With Cetrelimab, TAR-200 Alone, or Cetrelimab Alone in Participants With High-Risk Non-Muscle Invasive Bladder Cancer (NMIBC) Unresponsive to Intravesical Bacillus Calmette-Guérin (BCG) Who Are Ineligible for or Elected Not to Undergo Radical Cystectomy

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

The purpose of this study is to evaluate the overall complete response (CR) rate in participants treated with TAR-200 in combination with cetrelimab (Cohort 1), or TAR-200 alone (Cohort 2), or cetrelimab alone (Cohort 3) with Carcinoma in Situ (CIS), with or without concomitant high-grade Ta or T1 papillary disease; and disease-free survival (DFS) in participants treated with TAR-200 alone with papillary disease only (Cohort 4).

Study identification

NCT ID
NCT04640623
Recruitment status
Active, not recruiting
Study type
Interventional
Phase
Phase 2
Enrollment
220 participants

Conditions and interventions

Interventions

Drug · Biological

Eligibility (public fields only)

Age range
18 Years and older
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Dec 18, 2020 (Actual)
Primary completion
Jul 3, 2025 (Actual)
Completion
Sep 30, 2027 (Estimated)
Last update posted
Sep 25, 2026

2020 – 2027

United States locations

U.S. sites
22
U.S. states
14
U.S. cities
20
Facility City State ZIP Site status
Del Sol Research Management, LLC Tucson Arizona 85715 —
University of Southern California Los Angeles California 90033 —
Genesis Healthcare Partners - Genesis Research Greater Los Angeles Sherman Oaks California 91411 —
The Urology Center of Colorado Denver Colorado 80211 —
Foothills Urology - Golden Off Golden Colorado 80401 —
DuPage Medical Group Lisle Illinois 60532 —
Urology of Indiana Greenwood Indiana 46143 —
Wichita Urology Group Wichita Kansas 67226 —
Michigan Institute of Urology Troy Michigan 48084 —
NYU Langone Health New York New York 10017 —
SUNY Upstate Medical University Syracuse New York 13210-2375 —
Associated Medical Professionals Syracuse New York 13210 —
Levine Cancer Institute Charlotte North Carolina 28204 —
The Urology Group Cincinnati Ohio 45212 —
Urologic Consultants of Southeastern Pennsylvania Bala-Cynwyd Pennsylvania 19004 —
Thomas Jefferson University Philadelphia Pennsylvania 19107 —
Urology Associates, PC Nashville Tennessee 37209 —
Vanderbilt University Medical Center Nashville Tennessee 37232 —
Urology Austin Austin Texas 78745 —
University of Texas Southwestern Medical Center Dallas Texas 75390 —
Urology San Antonio Research San Antonio Texas 78229 —
Spokane Urology Spokane Washington 99202 —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 122 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT04640623, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Sep 25, 2026 · Synced Oct 21, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT04640623 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →