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CTRI Number  CTRI/2020/10/028626 [Registered on: 26/10/2020] Trial Registered Prospectively
Last Modified On: 24/02/2022
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug
Biological 
Study Design  Single Arm Study 
Public Title of Study   A Phase 4 Study of Combination Nivolumab and Ipilimumab in Patients with Advanced Renal Cell Carcinoma in India 
Scientific Title of Study   A Phase 4 Study of Nivolumab in Combination with Ipilimumab in Patients with Previously Untreated Advanced Renal Cell Carcinoma and Intermediate- or Poor-risk Factors Conducted in India  
Trial Acronym  There is no Trial Acronym. The study number is CA209-7C9 
Secondary IDs if Any  
Secondary ID  Identifier 
CA209-7C9 v 1.0_06 Feb 2020  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

Modification(s)  
Name  Dr Kartik Doshi 
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  91-2266288600  
Fax    
Email  Kartik.Doshi@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  
Bristol Myers Squibb Research and Development 
 
Primary Sponsor  
Name  BRISTOL MYERS SQUIBB INDIA PRIVATE LIMITED  
Address  BRISTOL MYERS SQUIBB INDIA PRIVATE LIMITED The India Bulls Finance Centre, 6th Floor, Tower 1, Senapati Bapat Marg, Elphinstone (W), Mumbai - 400013 
Type of Sponsor  Pharmaceutical industry-Global 
 
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 Ranjit Sahoo  All India Institute of Medical Sciences  Dr. B.R.A. Institute Rotary Cancer Hospital, All India Institutes of Medical Sciences, Room no 218, Department of Medical Oncology, Ansari Nagar, Department of Medical Oncology, New Delhi - 110029
New Delhi
DELHI 
9013956187

drranjitmd@gmail.com 
Dr Shekar Patil  HealthCare Global Enterprises Limited  HealthCare Global Enterprises Limited, HCG Towers, No. 08, P. kalingarao Road, Sampangiram nagar, Bangalore – 560027
Bangalore
KARNATAKA 
8033466170

spassociates6@gmail.com 
Dr Sandeep Goyle   Kokilaben Dhirubhai Ambani Hospital  Kokilaben Dhirubhai Ambani Hospital and Medical Research Institute, Rao Saheb, Achutrao Patwardhan Marg, Four Bungalows, Andheri West, Mumbai - 400053
Mumbai
MAHARASHTRA 
9322527910

sandeep.goyle@kokilabenhospitals.com 
Dr Amit Rauthan  Manipal Hospital  Manipal Hospital, # 98, HAL Airport Road, Bangalore - 560017
Bangalore
KARNATAKA 
9880463958

amitrauthan@yahoo.com 
Dr Vashishth Maniar  Mumbai Oncocare Centre  Mumbai Oncocare Centre (Unit of Cellcure Cancer Centre Pvt Ltd), 2nd floor, Majithia apartment, God’s Gift Premises Co-op Society Ltd, S.V. Road, Vile Parle - 400056
Mumbai
MAHARASHTRA 
98198334571

vpm@mocindia.co.in 
Dr Chandrakanth M V  Narayana Superspeciality Hospital  Narayan Superspeciality Hospital, 120/1, Andul Road, Haora - 71103, West Bengal
Haora
WEST BENGAL 
7738519198

drmvch@gmail.com 
Dr Vineet Talwar  Rajiv Gandhi Cancer Institute & Research Centre  Rajiv Gandhi Cancer Institute & Research Centre, Department of Medical Oncology Sir Chotu Ram Marg, Rohini Institutional Area, Sector 5, Rohini, Delhi - 110085
New Delhi
DELHI 
9810241512

drvineettalwar@yahoo.com 
Dr Lakshmi Haridas K  Regional Cancer Centre  Regional Cancer Centre, Department of Medical Oncology, Medical College P.O, Thiruvanthapuram - 695011
Thiruvananthapuram
KERALA 
9447206106

lakshmiharidasrcc@gmail.com 
Dr Minish Jain  Ruby Hall Clinic  Grant Medical Foundation Ruby Hall clinic, 40 Sassoon Road, Pune - 411001
Pune
MAHARASHTRA 
9823133390

minishjain009@gmail.com 
Dr Amit Joshi  Tata Memorial Hospital  Tata Memorial Hospital, Dept of medical oncology, HBB, 11th floor, room no:1105, Dr. E Borges Road, Parel, Mumbai-400012
Mumbai
MAHARASHTRA 
9769331525

dramitjoshi74@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 10  
Name of Committee  Approval Status 
Ethics Committee All India Institute of Medical Sciences  Approved 
Ethics Committee of Manipal Hospitals  Approved 
HCG Central Ethics Committee   Approved 
Human Ethics Committee RCC   Approved 
INSTITUTIONAL ETHICS COMMITTEE Kokilaben Dhirubhai Ambani Hospital & Medical Research Institute  Approved 
Institutional Review Board Institutional Review Board Institutional Review Board Rajiv Gandhi Cancer Institute & Research Centre  Approved 
Mumbai Oncocare Central IEC  Approved 
NSH ETHICS COMMITTEE  Approved 
Poona Medical Research Foundation  Approved 
TMH, Institutional Ethics Committee-II  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Approved/Obtained 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: C790||Secondary malignant neoplasm of kidney and renal pelvis,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nivolumab in Combination with Ipilimumab  Participants will receive a combination dosing regimen of nivolumab 3 mg/kg as a 30-minute IV infusion + ipilimumab 1 mg/kg as a 30-minute IV infusion Q3W followed by a single-dose agent of nivolumab 3 mg/kg Q2W for a maximum of 52 weeks or until treatment is no longer tolerated by the participant or withdrawal of consent. The first dose is to be administered within 28 days after signing the ICF. 
Comparator Agent  Not APPLICABLE  Not APPLICABLE 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  1) Signed Written Informed Consent
a) Participants must have signed and dated an Institutional Review Board (IRB)/Independent Ethics Committee (IEC)-approved written ICF in accordance with regulatory and institutional guidelines. This must be obtained before the performance of any protocolrelated procedures that are not part of normal participant care.
b) Participants must be willing and able to comply with scheduled visits, treatment schedule,laboratory tests, biomarker and PK testing, and other requirements of the study.
2) Type of Participant and Target Disease Characteristics
a) Histological confirmation of renal carcinoma with clear cell component including participants who may have sarcomatoid features. Advanced (not amenable to curative surgery or radiation therapy) RCC or mRCC.
b) No prior systemic therapy for RCC with the following exception:
i) One prior adjuvant or neoadjuvant therapy for completely resected RCC
2b). These drugs must be discontinued 6 months prior to study entry. All AEs related to prior adjuvant or neoadjuvant therapy must have returned to baseline, and eligible patients must not have experienced severe or life-threatening immune-related AEs except those that are unlikely to reoccur with standard countermeasures (eg, hormone replacement after adrenal crisis).
c) Measurable disease lesion by CT or MRI per RECIST 1.1 criteria. Radiated lesions cannot be used as measurable lesions unless there is clear evidence of progression.
d) KPS of at least 70%
e) Qualifies as intermediate or poor risk by meeting least 1 of the following prognostic factors as per the IMDC criteria:
i) KPS less than 80
ii) Less than 1 year from diagnosis including original localized disease (if applicable) to study enrollment
iii) Hemoglobin less than the lower limit of normal
iv) Corrected calcium concentration greater than 10 mg/dL.
v) Absolute neutrophil count greater than the ULN
vi) Platelet count greater than the ULN
3) Age and Reproductive Status
a) Male and female participants must be 18 years or older at the time of informed consent(ICF)
b) Women of childbearing potential (WOCBP) must have a negative serum or urine
pregnancy test (minimum sensitivity 25 IU/L or equivalent units of human horionic gonadotropin [HCG]) within 24 hours prior to the start of study treatment.
c) Women must not be breastfeeding.
d) WOCBP must agree to follow instructions for method(s) of contraception for the duration of study treatment plus 5 half-lives of study treatment plus 30 days (duration of ovulatory cycle) for a total of 5 months after the last dose of study treatment.
e) Males who are sexually active with WOCBP must agree to follow instructions for method(s) of contraception and fetal protection (Appendix 4) for the duration of treatment with nivolumab and ipilimumab plus 7 months after the last dose of study treatment. In addition, male participants must be willing to refrain from sperm donation during this time.
f) WOCBP who are continuously not heterosexually active are also exempt from
contraceptive requirements, and still must undergo pregnancy testing as described in this section.
g) Azoospermic males are exempt from contraceptive requirements unless the potential exists for fetal toxicity due to study drug being present in seminal fluid, even if the participant has undergone a successful vasectomy or if the partner is pregnant.
4) Other Inclusion Criteria
a) Indian participants with Indian ethnicity living in India.
b) An FFPE tissue block (prefer) or a minimum of 20 unstained slides [15 minimum if tissue is limited] of tumor tissue obtained from core biopsy, punch biopsy, excisional biopsy,surgical specimen or, archival tissue (if above is not available), preferably within 3 months,but no more than 12 months prior to enrollment, with an associated pathology report and with no intervening systemic anti-cancer treatment between time of acquisition and treatment assignment, must be sent to central laboratory during screening and must be
received by the central vendor (block or unstained slides) in order to start a participant on study treatment. Fine needle aspiration and biopsies of bone lesions that do not have a soft tissue component are unacceptable for submission.
c) The tissue submitted will be assessed for quality, and only those participants who meet tissue quality thresholds can have their treatment assigned. Central laboratory must provide IRT with confirmation of receipt of evaluable tumor tissue prior to participant treatment assignment. Subjects should not have received any systemic anti-cancer therapy after the
date that the submitted tumor tissue was obtained.
 
 
ExclusionCriteria 
Details   
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To assess the incidence of high-grade (CTCAE v5
Grade 3 to 4 and Grade 5) IMAEs in intermediateor
poor-risk participants with previously untreated,
advanced RCC who are treated with combination
therapy of nivolumab 3 mg/kg administered
intravenously over a period of 30 minutes Q3W for
the first 4 doses in combination with intravenous
ipilimumab 1 mg/kg over a period of 30 minutes,
followed by nivolumab 3 mg/kg Q2W administered
IV over a period of 30 minutes 
To assess the incidence of high-grade (CTCAE v5
Grade 3 to 4 and Grade 5) IMAEs in intermediateor
poor-risk participants with previously untreated,
advanced RCC who are treated with combination
therapy of nivolumab 3 mg/kg administered
intravenously over a period of 30 minutes Q3W for
the first 4 doses in combination with intravenous
ipilimumab 1 mg/kg over a period of 30 minutes,
followed by nivolumab 3 mg/kg Q2W administered
IV over a period of 30 minutes 
 
Secondary Outcome  
Outcome  TimePoints 
To characterize the outcome of all high grade
(CTCAE v5 Grade 3 to 4 and Grade 5) IMAEs in
intermediate or poor risk participants with
previously untreated, advanced RCC. 
EVERY 8 WEEKS 
To assess the effectiveness of nivolumab in
combination with ipilimumab by measuring ORR,
TTR, and DOR, using RECIST 1.1. 
Every 8 weeks 
 
Target Sample Size   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)   30/10/2020 
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="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   NIL 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary   A Phase 4 Study of Nivolumab in Combination with Ipilimumab in Patients with Previously Untreated Advanced Renal Cell Carcinoma and Intermediate- or Poor-risk Factors Conducted in India -[CA209-7C9] 

This study is done a part of the regulatory commitment  for marketing approval for Ipi and Nivo in IL RCC
 
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