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CTRI Number  CTRI/2018/02/012088 [Registered on: 22/02/2018] Trial Registered Prospectively
Last Modified On: 02/01/2019
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Single Arm Study 
Public Title of Study   Nivolumab Safety Study  
Scientific Title of Study   Safety Study of Nivolumab for Selected Advanced Malignancies in India 
Trial Acronym  Nivolumab study 
Secondary IDs if Any  
Secondary ID  Identifier 
CA209-887  Protocol Number 
 
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  Dr Pradeep Shetty 
Designation  Study director 
Affiliation  Bristol Myers Squibb India Pvt. Ltd. 
Address  The India Bulls Finance Centre, 6th Floor, Tower 1, Senapati Bapat Marg, Elphinstone (W), Mumbai - India
Bristol Myers Squibb India Pvt. Ltd.
Mumbai (Suburban)
MAHARASHTRA
400013
India 
Phone  91-02266288696  
Fax    
Email  Pradeep.Shetty@bms.com  
 
Details of Contact Person
Public Query  
Name  Shilpi Sinha 
Designation  Senior Site Manager 
Affiliation  Bristol Myers Squibb India Pvt. Ltd 
Address  The India Bulls Finance Centre, 6th Floor, Tower 1, Senapati Bapat Marg, Elphinstone (W), Mumbai - India
Bristol Myers Squibb India Pvt. Ltd
Mumbai (Suburban)
MAHARASHTRA
400013
India 
Phone  91-2266288645  
Fax    
Email  Shilpi.Sinha@bms.com  
 
Source of Monetary or Material Support  
BRISTOLMYERS SQUIBB INDIA PRIVATE LIMITED The India Bulls Finance Centre, 6th Floor, Tower 1, Senapati Bapat Marg, Elphinstone (W), Mumbai - 400013 
 
Primary Sponsor  
Name  BRISTOLMYERS SQUIBB INDIA PRIVATE LIMITED 
Address  The India Bulls Finance Centre, 6th Floor, Tower 1, Senapati Bapat Marg, Elphinstone (W), Mumbai - 400013 
Type of Sponsor  Pharmaceutical industry-Indian 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study
Modification(s)  
No of Sites = 10  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Prabhat Singh Malik  All India Institute Of Medical Sciences(AIIMS)  Institute Rotary Cancer Hospital, Room no - 245, 2nd Floor, Department of Medical Oncology, All India Institute of Medical Sciences, Ansari Nagar, New Delhi-110029, India
New Delhi
DELHI 		 919968325318

drprabhatsm@gmail.com 
DrMVT Krishna Mohan  Basavatarakam Indo-American Cancer Hospital & Research Institute  Road no. 10, Banjara Hills, Hyderabad – 500034, Telangana State, India
Hyderabad
ANDHRA PRADESH 		 9866154503

mvtkm@yahoo.com 
Dr Naresh Somani  Bhagwan Mahaveer Cancer Hospital and Research Center  Jawahar Lal Nehru Marg, Jaipur, Rajasthan, 302017
Jaipur
RAJASTHAN 		 919829014996

dr.nareshsomani@bmchrc.com 
Dr Ashish Singh  Christian Medical College  Department of Medical Oncology, Christian Medical College, Ida Scudder Road, Vellore – 632004 Tamil Nadu, India
Vellore
TAMIL NADU 		 91-416-2283040

ashishsingh@cmcvellore.ac.in 
Dr Shekar Gowda Patil  HCG Bangalore Institute Of Oncology  HealthCare Global Enterprises Limited, HCG Tower, #8, P. Kalinga Rao Road, Sampangi Ram Nagar, Bangalore – 560027, Karnataka, India
Bangalore
KARNATAKA 		 91-8033466170

spassociates@gmail.com 
Dr Nalini Kilara  Ramaiah Memorial Hospital  M S Ramaiah Medical College and Hospital, Dept. of Medical Oncology, MS Ramaiah Nagar, MSRIT Post, Bangalore – 560054, Karnataka, India
Bangalore
KARNATAKA 		 91-80-23601983

drnalini.msr@gmail.com 
Dr Hemant Malhotra  RK Birla Cancer Center  SMS Medical College & Attached Hospitals, Jaipur – 302004, Rajasthan, India
Jaipur
RAJASTHAN 		 9660121475

drmalhotrahemant@gmail.com 
Dr K C Lakshmaiah  Srinivasam Cancer Care Hospitals India Pvt. Ltd  #36, 1st A main, 5th Cross (Nethravathi street), Maruthi Nagar, Nagarbhavi Main Road, Bangalore- 560072, Karnataka, India
Bangalore
KARNATAKA 		 9448055949

kcluck@gmail.com 
Dr Raj Kumar Shrimali  Tata Medical Center  14, Major Arterial Road (EW), New Town, Rajarhat, Kolkata – 700160, West Bengal, India
Kolkata
WEST BENGAL 		 91-3366057405

raj.shrimali@tmckolkata.com 
Dr Kumar Prabhash  Tata Memorial Hospital  Department of Medical Oncology, HBB Block, 3rd Floor, Room no 304 Dr. Ernest Borges Marg, Parel, Mumbai – 40001, Maharashtra, India
Mumbai
MAHARASHTRA 		 91-2224177000

kprabhash1@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 10  
Name of Committee  Approval Status 
All India Institute of Medical Sciences   Approved 
Christian Medical College  Approved 
Ethics Committee, SMS Medical College and Attached Hospitals  Not Applicable 
HCG Bangalore Institute of Oncology   Approved 
Institutional Ethics Committee, Basavatarakam Indo American Cancer Hospital & Research Institute  Submittted/Under Review 
Institutional Ethics Committee, Bhagwan Mahaveer Cancer Hospital and Research Center  Submittted/Under Review 
MS Ramaiah Medical College and Hospitals  Approved 
SCCH – Institutional Ethics Committee - Srinvasam Cancer Care Hospitals India Pvt. Ltd  Approved 
Tata Medical Center   Approved 
Tata Memorial Hospital  Approved 
 
Regulatory Clearance Status from DCGI
Modification(s)  
Status 
Approved/Obtained 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  Locally advanced or metastatic non-small cell lung cancer (NSCLC) after prior chemotherapy OR advanced renal cell carcinoma (RCC) after prior therapy.,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nivolumab  Nivolumab at a dose of 3 mg/kg as a 60-minute IV infusion, on Day 1 of each treatment cycle every 2 weeks for 24 weeks or until progression, unacceptable toxicity, withdrawal of consent, or the study ends, whichever occurs first. 
Comparator Agent  Not applicable  Not applicable 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  Signed Written Informed Consent
Subjects must have signed and dated an IRB/IEC approved written informed consent form in accordance with regulatory and institutional guidelines. This must be obtained before the performance of any protocol related procedures that are not part of normal subject care.

b) Subjects must be willing and able to comply with scheduled visits, treatment schedule, laboratory tests
and other requirements of the study.

Type of Participant and Target Disease Characteristics

Locally advanced or metastatic non-small cell lung cancer (NSCLC) after prior chemotherapy OR advanced renal cell carcinoma (RCC) after prior therapy.

b) Eastern Cooperative Oncology Arm (ECOG) (Appendix 1) performance status of ≤ 1

c) Prior radiotherapy or radiosurgery must have been completed at least 2 weeks prior to randomization.

Age and Reproductive Status

a) Males and Females, ages ≥ 18 or age of majority
b) Women of childbearing potential (WOCBP) must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG) within 24 hours prior to the start of study treatment.
c) Women of childbearing potential (WOCBP) must agree to follow instructions for method(s) of contraception for the duration of treatment with nivolumab and 5 months after the last dose of study treatment. {i.e., 30 days (duration of ovulatory cycle) plus the time required for the investigational drug to undergo approximately 5 half-lives}.
d) Males who are sexually active with WOCBP must agree to follow instructions for method(s) of contraception for the duration of study treatment with nivolumab and 7 months after the last dose of study treatment {i.e., 90 days (duration of sperm turnover) plus the time required for the investigational drug to undergo approximately five halflives.}
e) Azoospermic males are exempt from contraceptive requirements. WOCBP who are continuously not heterosexually active are also exempt from contraceptive requirements, and still must undergo pregnancy testing as described in this section.

Investigators shall counsel WOCBP, and male participants who are sexually active with WOCBP, on the importance of pregnancy prevention and the implications of an unexpected pregnancy. Investigators shall advise on the use of highly effective methods of contraception, (Appendix 4 which have a failure rate of < 1% when used consistently and correctly.
 
 
ExclusionCriteria 
Details  Medical Conditions
a) Women who are pregnant or breastfeeding or with a positive pregnancy test at enrollment or prior to administration of study medication
b) Other medical conditions not to be participated in this study.

Prior or Concomitant Therapy
a) Ongoing or planned administration of anti-cancer therapies other than those specified in this study
b) Use of corticosteroids or other immunosuppressive medications with exceptions detailed in the protocol consistent with nivolumab program.
c) Treatment with any investigational agent within 14 days of first administration of study treatment.

Physical and Laboratory Test Findings

Allergies and Adverse Drug Reaction

Other Exclusion Criteria
a) Prisoners or participants who are involuntarily incarcerated. (Note: under certain specific circumstances a person who has been imprisoned may be included or permitted to continue as a participant. Strict conditions apply and Bristol-Myers Squibb approval is required.
b) Participants who are compulsorily detained for treatment of either a psychiatric or physical (e.g., infectious disease) illness.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Incidence and severity of treatment related AEs  During study period, at the time of discontinuation and 26 week for continuously treated patients by nivolumab after study period 
 
Secondary Outcome  
Outcome  TimePoints 
Incidence and severity of treatment-related select AEs, as specified in Section 10.3.2 of protocol in all treated participants  During study period, at the time of discontinuation and 26 week for continuously treated patients by nivolumab after study period 
Incidence of AEs that lead to discontinuation from treatment with nivolumab  At the time of discontinuation 
Incidence of all treatment-related SAEs  During study period, at the time of discontinuation and 26 week for continuously treated patients by nivolumab after study period 
 
Target Sample Size
Modification(s)  		 Total Sample Size="100"
Sample Size from India="100" 
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 4 
Date of First Enrollment (India)   15/03/2018 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="2"
Months="4"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   None-yet 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  

On 09 June 2016, nivolumab received approval from the Health Authorities of India for the treatment of (1) locally advanced or metastatic NSCLC after prior chemotherapy and. (2) advanced RCC after prior therapy in adults. As a condition of granting approval, the Health Authorities of India have required that a Phase 4 clinical trial in participants in India must be conducted by BMS so that adverse reactions related to the drug are reported to the Health Authorities in India and subsequently, any regulatory action resulting from their review should be complied with by the Sponsor.

The present study is a Phase 4 safety study of nivolumab to be conducted in India to comply with this condition specified in the approval letter received by BMS.

This study will provide information on the safety profile of nivolumab for the treatment of NSCLC or mRCC in a limited number of participants in India in accordance with the requirements of the Health Authorities of India.

This study will describe the adverse reactions that occur during 6 months of treatment with nivolumab in participants with advanced NSCLC or RCC in India. No test of the statistical hypothesis is planned in this study.

 
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