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CTRI Number  CTRI/2021/10/037225 [Registered on: 11/10/2021] Trial Registered Prospectively
Last Modified On: 15/05/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug
Radiation Therapy 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   A study of TAR-200 in combination with cetrelimab versus concurrent chemoradiotherapy in participants with muscle-invasive bladder cancer (MIBC) of the Bladder. 
Scientific Title of Study   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 
Trial Acronym   
Secondary IDs if Any
Modification(s)  
Secondary ID  Identifier 
17000139BLC3001, Amendment 5 dated 16/October/2024  Protocol Number 
NCT04658862  ClinicalTrials.gov 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name   
Designation   
Affiliation   
Address 




 
Phone    
Fax    
Email    
 
Details of Contact Person
Scientific Query  
Name  Sanish Davis 
Designation  GCO Head 
Affiliation  Janssen India 
Address  64/66, Senapati Bapat Marg

Mumbai
MAHARASHTRA
400016
India 
Phone  91-9820958943  
Fax    
Email  SDavis20@ITS.JNJ.com  
 
Details of Contact Person
Public Query  
Name  Sanish Davis 
Designation  GCO Head 
Affiliation  Janssen India 
Address  64/66, Senapati Bapat Marg

Mumbai
MAHARASHTRA
400016
India 
Phone  91-9820958943  
Fax    
Email  SDavis20@ITS.JNJ.com  
 
Source of Monetary or Material Support  
Janssen Research & Development LLC, 920 Route 202 South Raritan, New Jersey 08869 USA 
 
Primary Sponsor  
Name  Janssen Research Development LLC 
Address  920 Route 202 South Raritan, New Jersey 08869 USA 
Type of Sponsor  Pharmaceutical industry-Global 
 
Details of Secondary Sponsor
Modification(s)  
Name  Address 
Pharmaceutical Research Associates India Private Limited  Level 3 & 4, Prestige Blue Chip Software Park, Municipal No. 9, Hosur Road, Adugodi, Madiwala Range, Ward No. 63, Bangalore, Tavarekere, Bangalore South, Bangalore- 560029, Karnataka, India  
 
Countries of Recruitment     Argentina
Australia
Austria
Belgium
Brazil
Canada
China
Czech Republic
France
Germany
Greece
Hungary
India
Israel
Italy
Japan
Mexico
Netherlands
Poland
Portugal
Republic of Korea
Russian Federation
South Africa
Spain
Taiwan
Turkey
Ukraine
United States of America  
Sites of Study
Modification(s)  
No of Sites = 9  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Praveen jain  Aakash Healthcare Pvt Ltd  Hospital Plot, Road No. 201, Sector 3, Dwarka, New Delhi 110075, India
New Delhi
DELHI 		 9811775324

drparveen1010@gmail.com 
Dr Shailesh Bondarde  Apex Wellness Hospital  Basement- Room No: 01,Oncology department, Survey No.799, Plot no 187,Behind Prakash Petrol pump, Govind nagar, Nashik 422009, Maharashtra, India
Nashik
MAHARASHTRA 		 919822012427

shaileshbondarde1971@gamil.com 
Dr Chandragouda Dodagoudar  Dr. B. L. Kapur Memorial Hospital  Institutional Ethics Committee, Pusa Road, New Delhi-110005
North East
DELHI 		 9958450124

drchandru1976@yahoo.co.in 
Dr Bhalchandra Kashyapi  Jehangir Clinical Development Centre Pvt. Ltd.  OPD #25, Oncology division, Jehangir Hospital Premises, 32 Sassoon Road, Pune 411001, Maharashtra, India
Pune
MAHARASHTRA 		 9822406084

kashyapi1@gmail.com 
Dr Sudhir Rawal  Rajiv Gandhi Cancer Institute and Research Centre  Sector-5, Rohini, New Delhi 110085, India
New Delhi
DELHI 		 911147022058

sudhirrawal85@gmail.com 
Dr Mukesh Arya  Sardar Patel Medical College and AG of Hospitals  Dept. of Urology, Uro-science Centre, S.P. Medical College & A.G. of Hospitals, Bikaner 334003,Rajasthan, India
Bikaner
RAJASTHAN 		 911512226300

mcarya@yahoo.com 
Dr Rajesh Singh  State Cancer Institute, Indira Gandhi Institute of Medical Sciences  Sheikhpura, Patna, Bihar-800014, India
Patna
BIHAR 		 916122297099

drrajeshsingh@yahoo.com 
Dr Rajender Singh Arora  Sujan Surgical Cancer Hospital and Amravati Cancer Foundation  52/b Shankar Nagar Main Road, Amravati-444605
Amravati
MAHARASHTRA 		 9823097482

rsaroradr@gmail.com 
Dr Poornima Rangappa  Victoria Hospital, Bangalore Medical College and Research Institute  K R Road, Fort, Bangalore 560002, India
Bangalore
KARNATAKA 		 9845592183

drpoornimabmc@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 9  
Name of Committee  Approval Status 
Aakash Healthcare Super Speciality Hospital Institutional Ethics Committee  Approved 
AMRAVATI ETHICS COMMITTEE  Approved 
Apex Wellness Ethics Committee – AWEC  Approved 
Ethics Committee, Bangalore Medical College and Research Institute  Approved 
Ethics Committee, Jehangir Clinical Development Centre Pvt Ltd  Approved 
Ethics Committee, S.P. Medical College & AG of Hospitals  Approved 
Institutional Ethics Committee, Dr.B.L.Kapur Memorial Hospital, Pusa Road, New Delhi-110005, India  Approved 
Institutional Ethics Committee, Indira Gandhi Institute of Medical Sciences  Approved 
Institutional Review Board, Rajiv Gandhi Cancer Institute and Research Centre  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Approved/Obtained 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: C67||Malignant neoplasm of bladder,  
 
Intervention / Comparator Agent
Modification(s)  
Type  Name  Details 
Intervention  Cetrelimab (Treatment Arm 1 - TAR-200 plus Cetrelimab)  Participants will receive intravenous Cetrelimab every 3 weeks for the first 18 months in combination with TAR-200. 
Comparator Agent  Cisplatin (Treatment Arm 2 - Chemotherapy (cisplatin or gemcitabine) plus radiation therapy)  Participants will receive cisplatin intravenously. Participants will receive chemotherapy based on investigators choice from either cisplatin intravenously once weekly for 6 treatment weeks or gemcitabine intravenously twice weekly for 6 treatment weeks as Standard of Care (SOC) along with radiation therapy from either conventional radiotherapy (64 Gray [Gy], bladder only) for up to 6.5 treatment weeks or hypo-fractionated radiotherapy (55 Gy, bladder only) for up to 4 weeks. 
Comparator Agent  Conventional Radiation Therapy (Treatment Arm 2 - Chemotherapy (cisplatin or gemcitabine) plus radiation therapy)  Participants will receive conventional radiation therapy for bladder (64 Gray [Gy], bladder only) for up to 6.5 weeks  
Comparator Agent  Gemcitabine (Treatment Arm 2 - Chemotherapy (cisplatin or gemcitabine) plus radiation therapy)  Participants will receive gemcitabine intravenously. Participants will receive chemotherapy based on investigators choice from either cisplatin intravenously once weekly for 6 treatment weeks or gemcitabine intravenously twice weekly for 6 treatment weeks as Standard of Care (SOC) along with radiation therapy from either conventional radiotherapy (64 Gray [Gy], bladder only) for up to 6.5 treatment weeks or hypo-fractionated radiotherapy (55 Gy, bladder only) for up to 4 weeks. 
Comparator Agent  Hypo-fractioned radiation therapy (Treatment Arm 2 - Chemotherapy (cisplatin or gemcitabine) plus radiation therapy)  Participants will receive hypo-fractionated radiation therapy for bladder (55 Gy) for up to 4 weeks. 
Intervention  TAR-200 (Treatment Arm 1 - TAR-200 plus 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. 
 
Inclusion Criteria
Modification(s)  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  - 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 1500/cubic millimeters; Platelet count greater than or equal to 80,000/cubic millimeters; Hemoglobin greater than or equal to 9.0 grams per deciliter (g/dL); Liver function: (Total bilirubin less than or equal to 1.5 times upper limit of normal (ULN) or direct bilirubin less than or equal to ULN for participants with total bilirubin levels greater than 1.5 times ULN (except participants with Gilbert’s Syndrome, who must have a total bilirubin less than 3.0 mg/dL), and Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) less than or equal to 2.5 times institutional ULN); Renal function: Creatinine clearance greater than 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. 
 
ExclusionCriteria 
Details  - 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 more than 24 months prior to initiating study.
- Must not have diffuse CIS based on cystoscopy and biopsy. Diffuse, or multifocal, 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 
 
Method of Generating Random Sequence   Stratified randomization 
Method of Concealment   Centralized 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Time from Randomization to the First Bladder Intact Event-free Survival (BIEFS) event  Up to 8 years 
 
Secondary Outcome
Modification(s)  
Outcome  TimePoints 
Metastasis-free survival (MFS)  Up to 8 years 
Overall Survival (OS)  Up to 8 years 
Overall Response Rate (ORR)  Up to 8 years 
Number of Participants with Adverse Events (AEs) According to Common Terminology Criteria for Adverse Events (CTCAE)  Up to 8 years 
Number of Participants with AEs by Severity according to Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (NCI PRO-CTCAE)  Up to 8 years 
Number of Participants with Clinical Laboratory Abnormalities  Up to 8 years 
 
Target Sample Size   Total Sample Size="550"
Sample Size from India="75" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 3 
Date of First Enrollment (India)
Modification(s)  		 14/09/2022 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  01/04/2021 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="7"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Closed to Recruitment of Participants 
Recruitment Status of Trial (India)  Closed to Recruitment of Participants 
Publication Details   Not applicable 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - YES
  1. What data in particular will be shared?
    Response (Others) -  The data sharing policy of the Janssen Pharmaceutical Companies of Johnson & Johnson is available at www.janssen.com/clinical-trials/transparency.

  2. What additional supporting information will be shared?
    Response (Others) -  The data sharing policy of the Janssen Pharmaceutical Companies of Johnson & Johnson is available at www.janssen.com/clinical-trials/transparency.
  3. Who will be able to view these files?
    Response (Others) -  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 can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu

  4. For what types of analyses will this data be available?
    Response (Others) -  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 can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu

  5. By what mechanism will data be made available?
    Response (Others) -  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 can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu

  6. For how long will this data be available start date provided 01-01-2029 and end date provided 31-12-2034?
    Response (Others) -  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 can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - 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 can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu
Brief Summary
Modification(s)  		 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.
TAR-200 is an investigational drug delivery system. Cetrelimab (JNJ-63723283) is a fully human immunoglobulin G4 (IgG4) kappa monoclonal antibody (mAb) that binds programmed cell death protein 1 (PD-1). 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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