A Study of TAR-200 in Combination With Cetrelimab Versus Concurrent Chemoradiotherapy in Participants With Muscle-invasive Bladder Cancer (MIBC) of the Bladder
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04658862|
Recruitment Status : Recruiting
First Posted : December 9, 2020
Last Update Posted : July 23, 2021
|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|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||550 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
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.
Participants will receive Cetrelimab.
Other Name: JNJ-63723283
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.
Participants will receive cisplatin intravenously.
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).
- 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.
- 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.
- Overall Survival (OS) [ Time Frame: Up to 8 years ]OS is defined as time from randomization to death.
- 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).
- 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.
- 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.
- 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.
- 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.
- 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.
- Change from Baseline in Temperature [ Time Frame: From Baseline up to 8 years ]Change from baseline in temperature over time will be assessed.
- 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.
- 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).
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
|Contact: Study Contact||844-434-4210||JNJ.CT@sylogent.com|
|Study Director:||Janssen Research & Development, LLC Clinical Trials||Janssen Research & Development, LLC|