A Study of TAR-200 in Combination With Cetrelimab Versus Concurrent Chemoradiotherapy in Participants With Muscle-invasive Bladder Cancer (MIBC) of the Bladder

  • STATUS
    Recruiting
  • End date
    Dec 15, 2028
  • participants needed
    550
  • sponsor
    Janssen Research & Development, LLC
Updated on 8 April 2021

Summary

The purpose of study is to compare bladder intact-event free survival (BI-EFS) in participants receiving TAR-200 in combination with cetrelimab versus concurrent chemoradiotherapy.

Description

TAR-200 is a gemcitabine intravesical delivery system that provides a continuous release of gemcitabine into the urine. Urothelial carcinoma, specifically transitional cell carcinoma of the upper and lower genitourinary tract, has demonstrated meaningful responsiveness to deoxycytidine analogues. Gemcitabine has also demonstrated efficacy and a tolerable safety profile in NMIBC and metastatic urothelial carcinoma. Study consists of screening phase of 42 days, treatment phase and follow up phase. The total duration of study will be up to 8 years. Efficacy evaluation includes disease assessment (Cystoscopy/TURBT Biopsy/Pathology) and Patient Reported Outcomes (Quality of Life Assessments) and safety assessments includes vital sign measurements, 12-lead electrocardiogram (ECG), physical examinations, clinical laboratory tests, cystoscopic examination, anti-drug antibody (ADA) assessments, concomitant treatments/procedures and adverse event monitoring.

Details
Condition urinary tract neoplasm, bladder cancer, bladder disorder, Urothelial Cancer, Bladder Disorders, Bladder Carcinoma, Urologic Cancer, bladder tumor
Treatment cisplatin, Gemcitabine, Cetrelimab, TAR-200, Conventional radiation therapy, Hypo-fractioned radiation therapy
Clinical Study IdentifierNCT04658862
SponsorJanssen Research & Development, LLC
Last Modified on8 April 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age greater than or equal to 18 yrs?
Gender: Male or Female
Do you have any of these conditions: Bladder Carcinoma or Urologic Cancer or bladder cancer or bladder tumor or bladder disorder or urinary tract neoplasm or Bladder Disorders or Urotheli...?
Do you have any of these conditions: bladder cancer or Bladder Carcinoma or Bladder Disorders or Urologic Cancer or bladder tumor or urinary tract neoplasm or bladder disorder or Urotheli...?
Do you have any of these conditions: Bladder Disorders or Bladder Carcinoma or bladder tumor or bladder cancer or Urothelial Cancer or Urologic Cancer or bladder disorder or urinary tract...?
Do you have any of these conditions: bladder disorder or urinary tract neoplasm or Urothelial Cancer or Bladder Carcinoma or Urologic Cancer or bladder cancer or bladder tumor or Bladder ...?
Do you have any of these conditions: Bladder Carcinoma or Urothelial Cancer or bladder cancer or Bladder Disorders or urinary tract neoplasm or Urologic Cancer or bladder disorder or blad...?
Do you have any of these conditions: bladder cancer or Bladder Carcinoma or bladder tumor or Bladder Disorders or Urologic Cancer or Urothelial Cancer or bladder disorder or urinary tract...?
Do you have any of these conditions: Bladder Carcinoma or Urothelial Cancer or urinary tract neoplasm or Urologic Cancer or bladder tumor or Bladder Disorders or bladder cancer or bladder...?
Do you have any of these conditions: Urologic Cancer or bladder cancer or Urothelial Cancer or Bladder Disorders or Bladder Carcinoma or bladder disorder or urinary tract neoplasm or blad...?
Do you have any of these conditions: Bladder Carcinoma or urinary tract neoplasm or Bladder Disorders or bladder cancer or Urologic Cancer or bladder tumor or Urothelial Cancer or bladder...?
Do you have any of these conditions: Urologic Cancer or Bladder Carcinoma or Urothelial Cancer or bladder disorder or urinary tract neoplasm or bladder tumor or bladder cancer or Bladder ...?
Ineligible for or have elected not to undergo radical cystectomy
All adverse events associated with any prior surgery and/or intravesical therapy must have resolved to Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 Grade less than (<) 2 prior to randomization
Eastern Cooperative Oncology Group (ECOG) performance status Grade 0, 1, or 2
Thyroid function tests within normal range or stable on hormone supplementation per investigator assessment
Adequate bone marrow, liver, and renal function: Bone marrow function (without the support of cytokines or erythropoiesis-stimulating agent in preceding two weeks): Absolute neutrophil count (ANC) greater than or equal to (>=) 1,000/cubic millimeters (mm^3); Platelet count >=75,000/mm^3; Hemoglobin >=8.0 grams per deciliter (g/dL); Liver function: (Total bilirubin less than or equal to (<=) 1.5 _upper limit of normal (ULN) or direct bilirubin <= ULN for participants with total bilirubin levels greater than (>)1.5_ULN (except participants with Gilbert's Syndrome, who must have a total bilirubin < 3.0 mg/dL), and Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) less than or equal to (<=) 2.5 institutional ULN); Renal function: Creatinine clearance >40 mL/min either directly measured via 24-hour urine collection, calculation using the Cockcroft-Gault formula, or calculation for the modification of diet in renal disease for adult participants

Exclusion Criteria

Must not have had urothelial carcinoma or histological variant at any site outside of the urinary bladder. Ta/T1/Carcinoma in situ (CIS) of the upper urinary tract (including renal pelvis and ureter) is allowable if treated with complete nephrouretrectomy within 24 months
Must not have diffuse CIS based on cystoscopy and biopsy. Diffuse, or multi-focal, CIS is defined as the presence of at least 4 distinct CIS lesions in the bladder at the time of the Screening re-TURBT
Participants must not have evidence of cT4b, or N1-3, or M1 disease based on local radiology staging (chest, abdomen, and pelvis must be performed using Computed tomography [CT] or Magnetic resonance imaging [MRI]) within 42 days prior to randomization
Presence of any bladder or urethral anatomic feature that, in the opinion of the investigator, may prevent the safe placement, indwelling use, or removal of TAR 200
Evidence of bladder perforation during diagnostic cystoscopy
Clear my responses

How to participate?

Step 1 Connect with a site
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar
Name

Primary Contact

site
Name

Phone Email

0/250
Please verify that you are not a bot.

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Loading...

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 

 • 

Private

Reply by • Private
Loading...

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.
Loading...

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note