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

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Trial ID: NCT04658862

Purpose

The purpose of study is to compare bladder intact-event free survival (BI-EFS) in participants receiving TAR-200 in combination with intravenous (IV) 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

Stanford Investigator(s)

Ali Raza Khaki, MD
Ali Raza Khaki, MD

Clinical Assistant Professor, Medicine - Oncology

Eligibility


Inclusion Criteria:

   - 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 are within the normal range per investigator assessment (or
   stable on hormone supplementation). Investigators may consult an endocrinologist for
   participant eligibility assessment in the case of equivocal or marginal test results

   - 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 (>=) 1,500/cubic millimeters
   (mm^3); Platelet count >=80,000/mm^3; Hemoglobin >=9.0 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 >=30 mL/min using the Cockcroft-Gault formula. 24-hour
   creatinine clearance test will also be accepted for estimating renal function in
   situations where Cockcroft-Gault formula is not a good predictor of estimating
   adequate renal function

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
   nephroureterectomy more than 24 months prior to initiating study

   - 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. Participant is eligible
   if perforation has healed prior to randomization

Intervention(s):

biological: Cetrelimab

drug: TAR-200

drug: Cisplatin

drug: Gemcitabine

radiation: Conventional radiation therapy

radiation: Hypo-fractioned radiation therapy

Recruiting

I'm Interested

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Paige Nicole Baker
650-736-3687

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