| CTRI Number |
CTRI/2024/06/068865 [Registered on: 13/06/2024] Trial Registered Prospectively |
| Last Modified On: |
25/03/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Other |
|
Public Title of Study
|
A Study of Dostarlimab vs Placebo After Chemoradiation in Adult Participants With Locally Advanced Unresected Head and Neck Squamous Cell Carcinoma |
Scientific Title of Study
Modification(s)
|
A Randomized, Double-blind, Placebo-controlled Phase 3 Study to evaluate Dostarlimab as Sequential Therapy after Chemoradiation in Participants with Locally Advanced Unresected Head and Neck
Squamous Cell Carcinoma (JADE) |
| Trial Acronym |
JADE |
Secondary IDs if Any
Modification(s)
|
| Secondary ID |
Identifier |
| 2023-508613-17-00 |
EudraCT |
| 221530 Protocol Amendment 2 dated 26-Aug-24 |
Protocol Number |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Modification(s)
|
| Name |
Dr Gaurav Deshmukh |
| Designation |
Therapy Area Lead |
| Affiliation |
GSK Pharma India Private Limited |
| Address |
GSK Pharma India Private Limited C/O GlaxoSmithKline
Pharmaceuticals Limited Dr.Annie Besant Road, Worli, Mumbai,
MAHARASHTRA, India
Mumbai
MAHARASHTRA
400030
India
Mumbai
MAHARASHTRA
400030
India |
| Phone |
7977659978 |
| Fax |
|
| Email |
gaurav.a.deshmukh@gsk.com |
|
Details of Contact Person
Scientific Query
Modification(s)
|
| Name |
Dr Gaurav Deshmukh |
| Designation |
Therapy Area Lead |
| Affiliation |
GSK Pharma India Private Limited |
| Address |
GSK Pharma India Private Limited C/O GlaxoSmithKline
Pharmaceuticals Limited Dr.Annie Besant Road, Worli, Mumbai,
MAHARASHTRA, India
Mumbai
MAHARASHTRA
400030
India
Mumbai
MAHARASHTRA
400030
India |
| Phone |
7977659978 |
| Fax |
|
| Email |
Gaurav.a.deshmukh@gsk.com |
|
Details of Contact Person
Public Query
|
| Name |
Swapnali Raut |
| Designation |
Director, Clinical Operations India |
| Affiliation |
GSK Pharma India Private Limited |
| Address |
GSK Pharma India Private Limited C/O GlaxoSmithKline
Pharmaceuticals Limited Dr.Annie Besant Road, Worli, Mumbai,
MAHARASHTRA, India
Mumbai
MAHARASHTRA
400030
India
Mumbai
MAHARASHTRA
400030
India |
| Phone |
9821415224 |
| Fax |
|
| Email |
swapnali.a.raut@gsk.com |
|
|
Source of Monetary or Material Support
|
| GSK India Pharma Private Limited C/o GlaxoSmithKline Pharmaceuticals Limited, Dr. Annie
Besant Road, Worli, Mumbai 400030 |
|
|
Primary Sponsor
|
| Name |
GlaxoSmithKline Research & Development Limited |
| Address |
980 Great West Road Brentford Middlesex TW8 9GS UK |
| Type of Sponsor |
Pharmaceutical industry-Global |
|
|
Details of Secondary Sponsor
|
|
Countries of Recruitment
Modification(s)
|
Argentina
Australia
Belgium
Brazil
Canada
China
France
Germany
Greece
Hungary
India
Israel
Italy
Japan
Mexico
Norway
Poland
Portugal
Republic of Korea
Romania
Spain
Sweden
Taiwan
Turkey
United Kingdom
United States of America
Czech Republic
Egypt
Saudi Arabia
Singapore
Switzerland
United Arab Emirates |
Sites of Study
Modification(s)
|
| No of Sites = 15 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Sandip Kumar Barik |
AIIMS,Bhubaneswar |
AIIMS,Bhubaneswar,Sijua,Patrapada,Dumduma,Odisha,India,751019
Khordha
ORISSA |
9450381454
sandip.barik1@gmail.com |
| Dr Mukesh Patekar |
Artemis Hospital |
Hr Building 4th floor, Clinical Research Department, Sec-51, Gurugram, Haryana-122001
Gurgaon
HARYANA |
9968959935
mukesh.patekar@artemishospitals.com |
| Dr Deepak Gupta |
Bhagwan Mahaveer Cancer Hospital and Research Centre |
Clinical Trial & Research Department
05th Floor, Bhagwan Mahaveer Cancer Hospital & Research Center, J.L.N. Marg, Malviya Nagar, Jaipur. Pin 302017.
Jaipur
RAJASTHAN |
9001795275
drdeepakgupta@yahoo.co.in |
| Dr Sangeeta Jiwatani |
Daycare Angels under AOH (Advani Olickal Healthcare Service |
3rd floor, Sushrut Hospital and Research Centre, 365, Swastik park,
Chembur (East), Mumbai-400071, Maharashtra, India
Mumbai
MAHARASHTRA |
8097681981
sangeetajiwatani@hotmail.com |
| Dr K Lakshmi Priyadarshini |
HCG City cancer centre |
HCG City cancer centre,33-25-33, CH Venkata krishnayya street, suryarao pet, vijayawada-520002, Andhra Pradesh, India
Krishna
ANDHRA PRADESH |
8662436661
priyadarshini006@gmail.com |
| Dr Raj Nagarkar |
HCG Manavata Cancer Centre |
HCG Manavata Cancer Centre, Behind Shivang Auto, Mumbai Naka, Nashik, 422002
Nashik
MAHARASHTRA |
9823061929
drraj@manavatacancercentre.com |
| Dr Koushik Chatterjee |
IPGME & R and SSKM Hospital |
IPGME & R and SSKM Hospital, 244 AJC Bose Road, Kolkata – 700020
Kolkata
WEST BENGAL |
9874357580
drkoushik.chatterjee@gmail.com |
| Dr Rohan Bhise |
KLES Dr Prabhakar Kore Hospital & Medical Research Centre |
KLES Dr Prabhakar Kore Hospital & Medical Research Centre, Nehrunagar Belagavi-590010 Karnataka India
Belgaum
KARNATAKA |
9448866712
rohanbhise30@gmail.com |
| Dr Radhika Parimkayala |
MNJ Institute of Oncology & Regional Cancer Center |
MNJ Institute of Oncology & Regional Cancer Center, Red Hills, Hyderabad Telangana 500004
Hyderabad
TELANGANA |
9848792682
radhika.parimkayala@gmail.com |
| Dr Ghanshyam Patel |
Nirmal Hospital Pvt Ltd |
Nirmal Hospital Pvt Ltd, Ring Road, Surat- 395002, Gujarat, India
Surat
GUJARAT |
9376913131
drgnpatelonco@gmail.com |
| Dr Rejnish Kumar |
Regional Cancer Centre |
Regional Cancer Centre,
Medical College Campus, Medical College P O
Trivandrum-695011
Kerala, India
Thiruvananthapuram
KERALA |
9447072333
rejnish@gmail.com |
| Dr Minish Jain |
Ruby Hall Clinic |
New Cancer Building, 3rd Floor Oncology Department, 40 Sassoon Road, Pune, Maharashtra- 411001
Pune
MAHARASHTRA |
9823133390
minishjainresearch009@gmail.com |
| Dr Kumar Prabhash |
Tata Memorial Hospital |
Tata Memorial Hospital, Dr Ernest Borges Road, Parel East, Mumbai 400012
Mumbai
MAHARASHTRA |
9167760576
kprabhash1@gmail.com |
| Dr S G Raman |
The Voluntary Health Services |
Cancare Foundation, The Voluntary Health Services, SH 49A, Pallipattu, Taramani, Chennai-600113
Chennai
TAMIL NADU |
8939321897
sgraman8@gmail.com |
| Dr Shashidhar Karpurmath |
Vydehi Institute of Medical Sciences and Research Center |
Vydehi Institute of Medical Sciences and Research Center,
82, EPIP area, Whitefield, Bangalore 560 066, Karnataka
Bangalore
KARNATAKA |
8861085629
shashivk5@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 13 |
| Name of Committee |
Approval Status |
| Artemis Health Sciences Institutional Ethics Committee |
Approved |
| Human Ethics Committee RCC |
Submittted/Under Review |
| IEC, KLE Universitys KLE Dr PK Hospital & MRC |
Approved |
| INSTITUTIONAL ETHICS COMMITTEE, AIIMS Bhubaneswar |
Submittted/Under Review |
| Institutional Ethics Committee- HCG Curie CCC |
Approved |
| IPGME&R Research Oversight Committee |
Submittted/Under Review |
| Manavata Clinical Research Institute Ethics Committee |
Approved |
| MNJIORCC Ethics Committee |
Approved |
| Mumbai Oncocare Centre IEC |
Approved |
| NIRMAL HOSPITAL ETHICS COMMITTEE |
Approved |
| Poona Medical Research Foundation |
Approved |
| TMH, Institutional Ethics Committee-II |
Approved |
| Vydehi Institutional Ethics Committee |
Approved |
|
Regulatory Clearance Status from DCGI
Modification(s)
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C148||Malignant neoplasm of overlappingsites of lip, oral cavity and pharynx, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Dostarlimab |
50 mg/mL with a delivery volume of 10 mL
500 mg Q3W for 4 cycles then,
1000 mg Q6W for 7 cycles
|
| Comparator Agent |
Placebo
|
Commercially sourced sterile 0.9% Sodium Chloride solution for intravenous infusion
(normal saline)
Q3W for 4 cycles then Q6W for 7 cycles
|
|
Inclusion Criteria
Modification(s)
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Participants are eligible to be included in the study only if all of the following criteria apply:
1. Has newly diagnosed unresected LA histologically confirmed HNSCC of the oral cavity, oropharynx, hypopharynx or larynx and completed cisplatin plus radiotherapy (termed "CRT" in this protocol) with curative intent and has no evidence of distant metastatic disease.
2. Has provided acceptable core or excisional tissue demonstrating:
PD-L1 positive tumor status
If the primary tumor site is oropharyngeal carcinoma, the participant must have p16 IHC testing.
3. Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
4. Has adequate organ function.
NOTE: Tumors to be staged according to the 8th edition of the American Joint
Committee on Cancer (AJCC) staging manual (Amin, 2017).
NOTE: For eligibility assessment: TNM stage for oropharyngeal HNSCC must be based on p16 status as determined by CINtec assay.
|
|
| ExclusionCriteria |
| Details |
Participants are excluded from the study if any of the following criteria apply:
1. Has received prior radiation therapy, systemic therapy, targeted therapy, or radical surgery for management of head and neck cancer not considered part of CRT.
2. Has cancer outside of the oropharynx, larynx, hypopharynx or oral cavity, such as nasopharyngeal, sinus, other para-nasal, or other unknown primary head and neck cancer.
3. Has undergone any major surgical procedure or experienced significant traumatic injury within 28 days prior to enrolment.
4. Has any history of interstitial lung disease or pneumonitis (past or current).
5. Has cirrhosis or current unstable liver biliary disease per investigator assessment defined by the presence of ascites, encephalopathy, coagulopathy, hypoalbuminemia, esophageal/gastric varices, or persistent jaundice.
6. Has a history or current evidence of any medical condition, therapy, or laboratory abnormality that might confound the study results, interfere with their participation for the full duration of the study intervention, or indicate it is not in the best interest of the participant to participate, in the opinion of the investigator.
7. Is receiving any other anticancer or experimental therapy. No other experimental therapies (including but not limited to chemotherapy, radiation, hormonal treatment, antibody therapy, immunotherapy, gene therapy, vaccine therapy, or other experimental drugs) of any kind are permitted while the participant is receiving study intervention.
8. Previous treatment with anti-PD-1, anti-PD-L1, or anti-PD-L2 agent or an agent directed to another stimulatory or coinhibitory T-cell receptor (e.g., Cytotoxic T-lymphocyte associated protein 4 (CTLA4), (OX-40, CD134).
9. Is pregnant, breastfeeding, or expecting to conceive children within the projected duration of the study, starting with the Screening Visit through 120 days after the last dose of study intervention.
10. Has a history of severe allergic and/or anaphylactic reactions to chimeric, human or humanized antibodies, fusion proteins, or known allergies to dostarlimab or its excipients. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Event-free Survival (EFS) Assessed by Blinded Independent Central Review (BICR) |
Up to approximately 5 years |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Overall Survival (OS) |
Up to approximately 5 years |
| Event-free Survival (EFS) assessed by investigator |
Up to approximately 5 years |
| Number of Participants with treatment emergent adverse events (TEAEs), Immune-mediated TEAEs, and serious adverse events (SAEs) by severity |
Up to approximately 5 years |
| Number of Participants with TEAEs and SAEs leading to dose delays, withdrawals or death |
Up to approximately 5 years |
| Number of participants with clinically significant changes in laboratory, vital signs, and safety assessment parameters |
Up to approximately 5 years |
| Serum Concentration of Dostarlimab |
Up to approximately 15 months |
| Serum Concentration of Dostarlimab at End of Infusion (C-EoI) |
Up to approximately 15 months |
| Serum Predose trough concentration (Ctrough) of Dostarlimab |
Up to approximately 15 months |
| Number of Participants with Anti-Drug Antibodies against Dostarlimab |
Up to approximately 15 months |
|
|
Target Sample Size
|
Total Sample Size="864"
Sample Size from India="50"
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)
|
21/06/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
04/03/2024 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="5"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Open to Recruitment |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The goal of this study is to assess the safety and effectiveness of Dostarlimab compared to Placebo in adult participants with HNSCC (Head and Neck Squamous Cell Carcinoma) |