Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at Orange, California and other locations
Dates
study started
estimated completion

Description

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.

Official Title

A Phase 3, Multi-center, Randomized Study Evaluating Efficacy of TAR-200 in Combination With Cetrelimab Versus Concurrent Chemoradiotherapy in Participants With Muscle-Invasive Urothelial Carcinoma (MIBC) of the Bladder Who Are Not Receiving Radical Cystectomy

Details

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.

Keywords

Urinary Bladder Neoplasms Gemcitabine Cisplatin Cetrelimab TAR-200 Hypo-fractioned radiation therapy TAR-200 + Cetrelimab

Eligibility

You can join if…

Open to people ages 18 years and up

  • 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 (mm3); Platelet count >=75,000/mm3; 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 (>)1.5ULN (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

You CAN'T join if...

  • 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

Locations

  • University of California Irvine Medical Center not yet accepting patients
    Orange California 92868 United States
  • University of Southern California not yet accepting patients
    Los Angeles California 90033 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Janssen Research & Development, LLC
Links
To learn how to participate in this trial please click here.
ID
NCT04658862
Phase
Phase 3
Study Type
Interventional
Last Updated