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CTRI Number  CTRI/2019/04/018775 [Registered on: 24/04/2019] Trial Registered Prospectively
Last Modified On: 22/04/2020
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Vaccine 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Study of safety and effectiveness of IMU-131 comparing standard care chemotherapy in patients with Adenocarcinoma of the Stomach or Gastroesophageal Junction (a type of gastric cancer). 
Scientific Title of Study   A Phase 1b/2 Open-label Study with randomization in Phase 2 of IMU-131 HER2/neu Peptide Vaccine Plus Standard of Care Chemotherapy in Patients with HER2/neu Overexpressing Metastatic or Advanced Adenocarcinoma of the Stomach or Gastroesophageal Junction. 
Trial Acronym  IMU-131 
Secondary IDs if Any  
Secondary ID  Identifier 
IMU.ACS.001 Protocol Amendment 02 Dated 23/Nov/2018  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  Rashmi Chitgupi 
Designation  Associate Director - Clinical Management 
Affiliation  PPD Pharmaceutical Development India Private Limited  
Address  PPD Pharmaceutical Development India Private Limited. 101, A Wing, Fulcrum, Hiranandani Business Park Sahar Road, Andheri East, Mumbai India

Mumbai
MAHARASHTRA
400099
India 
Phone  912266022900  
Fax  912266022999  
Email  Rashmi.Chitgupi@ppdi.com  
 
Details of Contact Person
Public Query
Modification(s)  
Name  Rashmi Chitgupi 
Designation  Associate Director - Clinical Management 
Affiliation  PPD Pharmaceutical Development India Private Limited  
Address  PPD Pharmaceutical Development India Private Limited. 101, A Wing, Fulcrum, Hiranandani Business Park Sahar Road, Andheri East, Mumbai. India

Mumbai
MAHARASHTRA
400099
India 
Phone  912266022900  
Fax  912266022999  
Email  Rashmi.Chitgupi@ppdi.com  
 
Source of Monetary or Material Support  
Imugene Limited, 62 Lygon Street, Level 3 Carlton, VIC,3053 Australia 
 
Primary Sponsor  
Name  Imugene Limited 
Address  Level 3/62 Lygon St CARLTON VIC 3053 
Type of Sponsor  Pharmaceutical industry-Global 
 
Details of Secondary Sponsor  
Name  Address 
PPD Pharmaceuticals India Private Limited  101, A Wing, Fulcrum, Hiranandani Business Park, Sahar Road, Andheri East, Mumbai 400099, Maharashtra, India 
 
Countries of Recruitment     Georgia
Hong Kong
India
Taiwan
Thailand
Ukraine  
Sites of Study
Modification(s)  
No of Sites = 12  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Saroj Kumar Das Majumdar  All India Institute of Medical Sciences  Sijua, Patrapada, Bhubaneswar, Odisha, India 751019
Khordha
ORISSA 		 9438884066

sarojmajumdar@gmail.com 
Dr Chetan Deshmukh  Deenanath Mangeshkar Hospital and Research Centre - Hospital  Eradwane, Karve Road, Maharashtra, Pune, Maharashtra 411004 India
Pune
MAHARASHTRA 		 912049153000

drchetandeshmukh@gmail.com 
Dr Mamillapalli Gopichand  HCG City Cancer Centre  33-25-33, CH. Venkata krishnayya street, suryarao pet, Vijayawada-520002, Andhra Pradesh, India
Krishna
ANDHRA PRADESH 		 9885256059

mgopichand@yahoo.com 
Dr Rajnish Nagarkar  HCG Manavata Cancer Centre  Behind Shivang Auto, Mumbai Naka, Nashik, Maharashtra 422001, India
Nashik
MAHARASHTRA 		 919823061929

drrajnagarkar@yahoo.co.in 
Dr Vaibhav Choudhary  HCG NCHRI Cancer Centre  Khasra no. 50, 51 Mouja Wanjri, Bande Nawaz Nagar, Near automotive square, Kalmana, Ring Road, Nagpur-440026
Nagpur
MAHARASHTRA 		 919833621049

drvaibhav155@gmail.com 
Dr Rajesh Kumar Singh  Indira Gandhi Institute of Medical Sciences  Regional Cancer Centre Department of Radiation Oncology, Sheikhpura, Patna 800014
Patna
BIHAR 		 9939088899

drrajeshsingh@yahoo.com 
Dr Abhijit Chandra  King George Medical University  Chowk, Lucknow, Uttar Pradesh-226003, India
Lucknow
UTTAR PRADESH 		 0522-2258660

abhijitchandra@hotmail.com 
Dr Srinivasulu Mukta  MNJ Institute of Oncology and Regional Cancer Centre  Red hills Road, Beside Niloufer Hospital, Lakdikapool, Hyderabad, Telangana – 500004 India
Hyderabad
TELANGANA 		 919849044816

muktasrinivasulu@yahoo.co.in 
Dr Amit Kumar Dutta  North East Cancer Hospital and Research Institute  11thMile Amerigog, Jorabat, Guwahati 781023, Assam.
Kamrup
ASSAM 		 8723834334

dramitduttanechri@gmail.com 
Dr Lokanatha Dasappa  Shetty Hospital  Kaveri Nagar, Kodichikkanahalli,Bommanhalli, Bangalore 560 068, Karnataka, India
Bangalore
KARNATAKA 		 919845695589

shettyshospital@gmail.com 
Dr Tanuj Chawla  Tata Medical Centre  New Town, Rajarhat, Kolkata 700 156, India
Kolkata
WEST BENGAL 		 8420711222

tanujucms@yahoo.com 
Dr Giri Venkata  Victoria Hospital, BMCRI  Fort, Bangalore - 560 002. Karnataka, India
Bangalore
KARNATAKA 		 918026706264

drgiribmcri@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 12  
Name of Committee  Approval Status 
Ethics Committee of Bangalore Medical College and Research Institute  Approved 
HCG NCHRI Central Ethics Committee  Approved 
Institutional Ethics Committe, Deenanath Mangeshkar Hospital and Research Centre  Approved 
Institutional Ethics Committee - All India Institute of Medical Sciences  Submittted/Under Review 
Institutional Ethics Committee - North East Cancer Hospital and Research Institute  Approved 
Institutional Ethics Committee Indira Gandhi Institute of Medical Sciences  Submittted/Under Review 
Institutional Ethics Committee, King George’s Medical University  Submittted/Under Review 
Institutional Ethics Committee- HCG Curie City Cancer Centre  Submittted/Under Review 
Manavata Clinical Research Institute Ethics Committee  Approved 
MNJ Institute of Oncology and Regional Cancer Centre Ethics Committee  Approved 
Shetty Hospital Ethics Committee  Approved 
Tata Medical Center- Institutional Review Board (TMC-IRB)  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Approved/Obtained 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K318||Other specified diseases of stomach and duodenum,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  IMU- 131 HER2/neu Peptide Vaccine Plus Standard of Care Chemotherapy  Chemotherapy will be administered in 21-day cycles as tolerated to a maximum of 6 cycles. One or more chemotherapy treatments may be varied by dose, frequency or discontinued completely as determined by the investigator for the clinical care of the patient. 
Intervention  IMU-131 HER2/neu Peptide Vaccine  Injections of IMU-131-Montanide emulsion (IMU-131) at 50μg will be given to patients in the ‘IMU-131 plus chemotherapy’ group in the Phase 2 study on Days 0, 14, 35, 77, 140 and then every 63 days. 
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  1. Patient has been informed of the investigational nature of this study and has given
written informed consent in accordance with institutional local and national
guidelines
2. Age more than and equal to 20 years old
3. Life expectancy of at least 12 weeks
4. No prior chemotherapy or radiotherapy for advanced gastric or GEJ cancer within 3 months prior to Day 0
5. Metastatic gastric or GEJ adenocarcinoma or locally advanced disease not amenable to surgical resection
6. HER2/neu overexpression (3+ by immunohistochemistry (IHC) or if IHC 2+
confirmed by fluorescent in situ hybridization FISH] or chromogenic in situ hybridization [CISH]). Patients with IHC 2+ expression without confirmation of overexpression by fluorescent in situ hybridization [FISH] or chromogenic in situ
hybridization [CISH]) may be included in Phase 1b with agreement of Imugene Limited
7. ECOG performance status 0–2
8. At least one measurable lesion as defined by RECIST 1.1 criteria. Patients with non-measurable lesions may be included in Phase1b with agreement of Imugene Limited
9. Adequate left ventricular ejection function at baseline defined as LVEF > 50% by echocardiogram or MUGA scan (Multi Gated Acquisition Scan)
10. Adequate hematologic function absolute neutrophil count (ANC) ≥ 1.5 x 109/L, platelet count ≥ 100 x 109/L, and hemoglobin ≥ 9 g/dL;
11. Adequate liver function evidenced by bilirubin ≤ 1.5 x laboratory upper limit of
normal [ULN] and ALT and AST ≤ 3 x laboratory ULN if no liver involvement or ALT and AST ≤ 5 times laboratory ULN with liver involvement
12. Adequate renal function (creatinine ≤ 1.5 x laboratory ULN
13. Willing and able to comply with scheduled visits treatment plan laboratory tests and other study procedures
14. Male and female patients of childbearing potential must agree to use a highly effective method of contraception throughout the study and for at least 28 days after the last dose of assigned treatment . A patient is of childbearing potential if, in the opinion of the investigator, he/she is biologically capable of having children and is sexually active.


 
 
ExclusionCriteria 
Details  1. Previous treatment with trastuzumab or any other HER2/neu targeting antibody or
agent
2. Continuous systemic treatment with either corticosteroids (Greater than 10 mg daily prednisone equivalents) or other immunosuppressive medications within 4 weeks prior to first dose of study treatment. Inhaled or topical steroids and physiological replacement doses of up to 10 mg daily prednisone equivalents are permitted in
the absence of active auto-immune disease
3. Prior organ transplant
4. Patient not considered a candidate for 5-FU, capecitabine,cisplatin or
oxaliplatin chemotherapy;
5. History of documented congestive heart failure; angina pectoris requiring
antianginal medication; evidence of transmural infarction on ECG; poorly
controlled hypertension; clinically significant valvular heart disease; high risk
uncontrolled arrhythmias; or New York Heart Association (NYHA) class II heart
disease;
6. If on warfarin (Coumadin®) or other vitamin K antagonists;
7. Concurrent active malignancy except for adequately controlled limited basal cell
carcinoma of the skin
8. Peripheral neuropathy or hearing loss of NCI CTCAE Grade greater than and equal to 2
9. History of uncontrolled seizures, central nervous disorders or psychiatric disability
judged by the investigator to be clinically significant and precluding informed
consent, participation in the study, or adversely affecting compliance to study
drugs;
10. Active infection requiring IV antibiotics;
11. Positive for human immunodeficiency virus (HIV) (HIV 1/2 antibodies) or active
hepatitis B (HBsAg reactive) or active hepatitis C (HCV ribonucleic acid [RNA]
qualitative) infection;
12. Pregnant or lactating females;
13. Major surgery within 4 weeks prior to study entry. Minor surgery (excluding
diagnostic biopsy) within 1 week prior to study entry;
14. Has received a live-virus vaccination within 4 weeks of first study vaccination.
Seasonal flu vaccines that do not contain live virus are permitted;
15. Current or recent (within 4 weeks of first IMU-131 vaccination) treatment with
another investigational drug or participation in another investigational study.
16. Phase 2: Patients with a known diphtheria toxoid hypersensitivity.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Centralized 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
To evaluate the clinical efficacy of IMU-131 plus chemotherapy
compared to chemotherapy alone based on overall survival (OS). 
22 Months 
 
Secondary Outcome  
Outcome  TimePoints 
To evaluate other efficacy measures of IMU-131 plus
chemotherapy compared to chemotherapy alone including
progression-free survival (PFS), time to progression (TTP),
disease control rate (DCR), objective response rate (ORR),
duration of objective response (DOR) and change in tumor size
(CTS) according to Response Evaluation Criteria In Solid Tumors
version 1.1 (RECIST 1.1) for the progression evaluation of
radiographic data. 		 22 Months 
 
Target Sample Size   Total Sample Size="68"
Sample Size from India="32" 
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 2 
Date of First Enrollment (India)
Modification(s)  		 09/09/2019 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  13/03/2019 
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)   Open to Recruitment 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   Not Applicable 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  

Phase 2 is an open-label, randomized, multicenter study designed to assess the clinical activity, immunogenicity, safety and tolerability of IMU-131. The length of Phase 2 will be approximately 22 months: 15 months’ recruitment and an estimated 22 months’ follow-up from initiation of randomization to realization of the required number of deaths. It is anticipated that an additional 3 months will be required to complete the analyses following realization of the last required death.

Please be informed that Moldova ( Country ) is also participating in this study.

 
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