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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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ClinicalTrials.gov Identifier: NCT04658862
Recruitment Status : Recruiting
First Posted : December 9, 2020
Last Update Posted : May 28, 2021
Sponsor:
Information provided by (Responsible Party):
Janssen Research & Development, LLC

Brief 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.

Condition or disease Intervention/treatment Phase
Urinary Bladder Neoplasms Drug: Cetrelimab Drug: TAR-200 Drug: Cisplatin Drug: Gemcitabine Radiation: Conventional radiation therapy Radiation: Hypo-fractioned radiation therapy Phase 3

Detailed 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 550 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : December 7, 2020
Estimated Primary Completion Date : December 30, 2026
Estimated Study Completion Date : December 15, 2028

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bladder Cancer

Arm Intervention/treatment
Experimental: TAR-200 + Cetrelimab
Participants will receive intravesical TAR-200 every 3 weeks (21 days indwelling) for first 18 weeks and thereafter from Week 24 every 12 weeks through study Year 3 in combination with Cetrelimab.
Drug: Cetrelimab
Participants will receive Cetrelimab.
Other Name: JNJ-63723283

Drug: TAR-200
Participants will receive intravesical TAR-200.
Other Name: JNJ-17000139

Active Comparator: Chemotherapy (cisplatin or gemcitabine) + Radiation Therapy
Participants will receive chemotherapy based on investigator's choice from either cisplatin intravenously once weekly for 6 weeks or gemcitabine intravenously twice weekly for 6 weeks as Standard of Care (SOC) along with radiation therapy from either conventional radiotherapy (64 Gray [Gy], bladder only) for up to 6.5 weeks or hypo-fractionated radiotherapy (55 Gy, bladder only) for up to 4 weeks.
Drug: Cisplatin
Participants will receive cisplatin intravenously.

Drug: Gemcitabine
Participants will receive gemcitabine intravenously.

Radiation: Conventional radiation therapy
Participants will receive conventional radiation therapy for bladder (64 gy).

Radiation: Hypo-fractioned radiation therapy
Participants will receive hypo-fractioned radiation therapy for bladder (55 gy).




Primary Outcome Measures :
  1. Time from Randomization to the First Bladder Intact Event-free Survival (BI-EFS) event [ Time Frame: Up to 8 years ]
    Time from randomization to the first BI-EFS event includes histologically proven presence of muscle-invasive bladder cancer (MIBC), clinical evidence of nodal or metastatic disease (as assessed by RECIST 1.1 criteria), radical cystectomy (RC), or death due to any cause.


Secondary Outcome Measures :
  1. Metastasis-free survival (MFS) [ Time Frame: Up to 8 years ]
    MFS is measured from time from randomization to first radiologic (as assessed by RECIST 1.1 criteria) or histologic evidence of metastatic disease or death due to any cause.

  2. Overall Survival (OS) [ Time Frame: Up to 8 years ]
    OS is defined as time from randomization to death.

  3. Overall Response Rate (ORR) [ Time Frame: Up to 8 years ]
    ORR is defined as proportion of participants who have complete response (CR) (defined as Negative biopsy, and Computed tomography/Magnetic resonance imaging [CT/MRI] of chest, abdomen, and pelvis showing no evidence of local recurrence, progression, or metastatic disease) or partial response (PR): (defined as down staging: biopsy proven non-invasive disease less than [<] T1 and CT/MRI of chest, abdomen, and pelvis showing no evidence of metastatic disease) or non-response (those not achieving a complete response or down-staging, or those who do not undergo a biopsy will be considered non-responders).

  4. Number of Participants with Adverse Events (AEs) According to Common Terminology Criteria for Adverse Events (CTCAE) [ Time Frame: Up to 8 years ]
    Number of Participants with AEs by Severity as assessed by CTCAE version 5 will be reported. Grade refers to the severity of the AE as follows: Grade 1- Mild, asymptomatic or mild symptoms, clinical or diagnostic observations only, intervention not indicated; Grade 2- Moderate, minimal, local or noninvasive intervention indicated, limiting age-appropriate instrumental Activities of Daily Living (ADL); Grade 3- Severe or medically significant but not immediately life-threatening, hospitalization or prolongation of hospitalization indicated, disabling, limiting self-care ADL; Grade 4- Life-threatening consequences, urgent intervention indicated; Grade 5- Death related to AE.

  5. Number of Participants with AEs by Severity according to Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (NCI PRO-CTCAE) [ Time Frame: Up to 8 years ]
    NCI PRO-CTCAE is a patient-reported outcome measure used to evaluate symptomatic toxicity in participants on cancer clinical trials. The NCI PRO-CTCAE is an item bank. The items selected for this study include all NCI PRO-CTCAE gastrointestinal items and urinary items. These items include taste changes, decreased appetite, nausea, vomiting, heartburn, gas, bloating, hiccups, constipation, diarrhea, abdominal pain, fecal incontinence, painful, urination, urinary urgency, urinary frequency, change in usual urine color, and urinary incontinence.

  6. Number of Participants with Clinical Laboratory Abnormalities [ Time Frame: Up to 8 years ]
    Number of participants with clinical laboratory abnormalities will be reported. Severity will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0. Severity scale ranges from Grade 1 (Mild) to Grade 5 (Death). Grade 1= Mild, Grade 2= Moderate, Grade 3= Severe, Grade 4= Life-threatening, and Grade 5= Death related to adverse event.

  7. Change from Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) [ Time Frame: From Baseline up to 8 years ]
    Change from baseline in systolic and diastolic blood pressure over time will be assessed.

  8. Change From Baseline in Heart Rate [ Time Frame: From Baseline up to 8 years ]
    Change from baseline in heart rate over time will be assessed.

  9. Change from Baseline in Temperature [ Time Frame: From Baseline up to 8 years ]
    Change from baseline in temperature over time will be assessed.

  10. Safety Assessment by Changes From Baseline in Physical Examinations [ Time Frame: From Baseline up to 8 years ]
    Physical examination which will be comprised of an examination of head, ears, eyes, nose, throat and neck, cardiovascular, respiratory, abdomen, musculoskeletal, skin, and genitourinary systems as assessed as normal or abnormal. A change from normal to abnormal or abnormal to normal, will be registered as a change from baseline.

  11. Change from Baseline in Performance Status as assessed by Eastern Cooperative Oncology Group (ECOG) Scale [ Time Frame: From baseline up to 8 years ]
    Change from baseline in performance status will be assessed by ECOG scale, where Grade 0 (fully active), Grade 1 (restricted in physically strenuous activity), Grade 2 (ambulatory and capable of all self-care), Grade 3 (capable of only limited self-care), Grade 4 (completely disabled), and Grade 5 (dead).



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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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:

  • 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

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): NCT04658862


Contacts
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Contact: Study Contact 844-434-4210 JNJ.CT@sylogent.com

Locations
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Sponsors and Collaborators
Janssen Research & Development, LLC
Investigators
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Study Director: Janssen Research & Development, LLC Clinical Trials Janssen Research & Development, LLC
Additional Information:
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Responsible Party: Janssen Research & Development, LLC
ClinicalTrials.gov Identifier: NCT04658862    
Other Study ID Numbers: CR108917
2020-002620-36 ( EudraCT Number )
17000139BLC3001 ( Other Identifier: Janssen Research & Development, LLC )
First Posted: December 9, 2020    Key Record Dates
Last Update Posted: May 28, 2021
Last Verified: May 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: The data sharing policy of the Janssen Pharmaceutical Companies of Johnson & Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu
URL: https://www.janssen.com/clinical-trials/transparency

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Urinary Bladder Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Urinary Bladder Diseases
Urologic Diseases
Gemcitabine
Antineoplastic Agents
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs