| CTRI Number |
CTRI/2025/04/085913 [Registered on: 29/04/2025] Trial Registered Prospectively |
| Last Modified On: |
04/05/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A study to evaluate the safety of dostarlimab in adult patients in India with recurrent or advanced endometrial cancer. |
|
Scientific Title of Study
|
Phase 4, open label, non-comparative,
interventional, multicenter study to evaluate the
safety of dostarlimab in adult patients in India
with mismatch repair deficient
(dMMR)/microsatellite instability-high (MSI-H)
recurrent or advanced endometrial cancer (EC)
that has progressed on or following prior
treatment with a platinum-containing regimen |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| 221460 Amendment 01 dated 01 Oct 2024 |
Protocol Number |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Modification(s)
|
| Name |
Dr Gaurav Deshmukh |
| Designation |
Senior Medical Manager |
| Affiliation |
GSK |
| Address |
GlaxoSmithKline Pharmaceuticals,
Senior Medical Manager,
Medical Affairs,
3rd floor,
252 Dr Annie Besant Road Worli, Mumbai
Mumbai
MAHARASHTRA
400030
India |
| Phone |
917977659978 |
| Fax |
|
| Email |
gaurav.a.deshmukh@gsk.com |
|
Details of Contact Person
Scientific Query
Modification(s)
|
| Name |
Dr Gaurav Deshmukh |
| Designation |
Senior Medical Manager |
| Affiliation |
GSK |
| Address |
GlaxoSmithKline Pharmaceuticals,
Medical Affairs,
3rd floor,
252 Dr Annie Besant Road Worli, Mumba
Mumbai
MAHARASHTRA
400030
India |
| Phone |
917977659978 |
| Fax |
|
| Email |
gaurav.a.deshmukh@gsk.com |
|
Details of Contact Person
Public Query
Modification(s)
|
| Name |
Dr Gaurav Deshmukh |
| Designation |
Senior Medical Manager |
| Affiliation |
GSK |
| Address |
GlaxoSmithKline Pharmaceuticals,
Medical Affairs,
3rd floor,
252 Dr Annie Besant Road Worli, Mumbai
Mumbai
MAHARASHTRA
400030
India |
| Phone |
917977659978 |
| Fax |
|
| Email |
gaurav.a.deshmukh@gsk.com |
|
|
Source of Monetary or Material Support
|
| GlaxosmithKline Pharmaceuticals, 252, Dr Annie Besant Rd, Hanuman Nagar, Worli, Mumbai, Maharashtra 400030. India. |
|
|
Primary Sponsor
|
| Name |
GlaxosmithKline |
| Address |
252, Dr. Annie Besant Road Worli 400030 Mumbai, India. |
| Type of Sponsor |
Pharmaceutical industry-Global |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 16 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Lovenish Goyal |
Aadhar Health Institute |
Tosham Road, Near South Bypass Crossing, Hisar, Haryana - 125005, India
Hisar
HARYANA |
9896539142
drlovenish@gmail.com |
| Dr Amit Sehrawat |
All India Institute of Medical Sciences |
Virbhadra Road, Rishikesh, 249201
Dehradun
UTTARANCHAL |
919858474477
amit.monc@aiimsrishikesh.edu.in |
| Dr Sourav Kumar Mishra |
All India Institute of Medical Sciences |
Department of Oncology, Sijua Patrapada Bhubaneshwar Odhisha 751019 India
Khordha
ORISSA |
7008651823
drskmishra.trial@gmail.com |
| Dr Nikhil Suresh Ghadyalpatil |
Apollo Hospitals Enterprise Limited, Hyderabad |
Apollo Hospitals, Jubilee Hills, Hyderabad - 500096, Telangana, India
Hyderabad
TELANGANA |
8008037474
nikhilghadyalpatil@gmail.com |
| Dr Priya Tiwari |
Artemis Hospital |
Sector 51, Gurugram - 122001, Haryana, India
Gurgaon
HARYANA |
8377828241
Priya.Tiwari@artemishospitals.com |
| Dr Tanmoy Kumar Mandal |
Binayak Multispeciality Hospital |
Binayak Enclave, 59, Kalicharan Ghosh Road, Kolkata - 700050, West Bengal, India
Kolkata
WEST BENGAL |
9051238499
tanmoy.nrs@gmail.com |
| Dr Shilpa Kandipalli |
King George Hospital |
Town Main Road, Visakhapatnam - 530001, Andhra Pradesh, India
Visakhapatnam
ANDHRA PRADESH |
9440731463
drshilpakresearch@gmail.com |
| Dr Ashish Anand Joshi |
Mumbai Oncocare Centre, |
Andheri, Mumbai, 400057
Maharashtra
Mumbai
MAHARASHTRA |
9833662891
ashjoshi44@mocindia.co.in |
| Dr Minish Mahendra Jain |
Noble Hospital Pvt.Ltd |
Department of oncology, 153 Magarpatta City Road Hadapsar Pune Maharashtra 411013 India
Pune
MAHARASHTRA |
9823133390
minishjain009@gmail.com |
| Dr Shriniwas Kulkarni |
Sahyadri Super Specialty Hospital |
Department of Oncology, S No 163, Bhosale Nagar Hadapsar Pune 411028 India
Pune
MAHARASHTRA
Pune
MAHARASHTRA |
9970279438
drshriniwaskulkarni@gmail.com |
| Dr Maheboob Basade |
Saifee Hospital, |
15/17, Maharshi Karve Road,Opp Charni Road Station, Mumbai 400004
Mumbai
MAHARASHTRA |
9821062692
basade@gmail.com |
| Dr Radheshyam Naik |
Sammprada Medcare Private Limited |
No 76-1-1, VR layout, Sarakki Main Road, 1st Phase, JP Nagar, Bangalore - 560078, Karnataka, India
Bangalore
KARNATAKA |
9731310682
radheshyam.n@yahoo.com |
| Dr Anita Ramesh |
Saveetha Medical College and Hospital |
Saveetha Nagar, Thandalam, Chennai - 602105, Tamil Nadu, India
Chennai
TAMIL NADU |
9840758567
anitachandra100@hotmail.com |
| Dr Aditya Sarin |
Sir Ganga Ram Hospital |
Rajinder Nagar, New Delhi, 110060
New Delhi
DELHI |
919927287871
dradityasarin@gmail.com |
| Dr Ghanashyam Biswas |
Sparsh Hospital & Critical Care |
A/407, Saheed Nagar, Bhubaneswar - 751007, Odisha, India
Khordha
ORISSA |
9937500878
drgbiswas@gmail.com |
| Dr Sudeep Gupta |
Tata Memorial Centre, |
Dr. Ernest Borges Marg, Parel, Mumbai- 400012, Maharashtra, India
Mumbai
MAHARASHTRA |
9821298642
sudeepgupta04@yahoo.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 17 |
| Name of Committee |
Approval Status |
| Aadhar institutional Ethics committee |
Approved |
| Ethics Committee relating to Clinical Trial All India Institute Of Medical Sciences Rishikesh |
Approved |
| IEC Mumbai Oncocare Centre |
Approved |
| IEC Sparsh Hospitals Critical care Private limited |
Approved |
| IEC, AIIMS,Rishikesh |
Approved |
| IEC, Artemis Health Sciences |
Approved |
| IEC, King George Hospital |
Approved |
| IEC-SAMMPRADA MEDICARE PRIVATE LIMITED |
Approved |
| IEC-Saveetha Medical College Hospital |
Approved |
| Institutional Ethics Committee Binayak Multispeciality Hospital |
Approved |
| Institutional Ethics Committee, AIIMS,Bhubaneswar |
Approved |
| Institutional Ethics Committee, Tata Memorial Hospital |
Approved |
| Institutional Ethics Committee-Clinical Studies APOLLO HOSPITALS ENTERPRISE LIMITED Research And Innovations |
Approved |
| Noble Hospital Institutional Ethics Committee Noble Hospitals Pvt. Ltd. |
Approved |
| Sahyadri Hospitals Private Ltd. Ethics Committee |
Approved |
| Saifee Hospital Institutional Review Board Saifee Hospital |
Approved |
| Sir Gangaram Ethics Comittee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C541||Malignant neoplasm of endometrium, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Dostarlimab concentrate for solution for infusion 500 mg/10 mL |
Unit Dose Strength: One vial of 500mg concentrate for solution for infusion 500mg/10ml.
Dosage and Frequency: In the current study, Dostarlimab will be administered as 500 mg every 3 weeks for first 4 cycles, 1000mg for cycle 5 after 3 weeks (of cycle 4) followed by 1000mg for cycle 6 after 6 weeks (of cycle 5).
Route of Administration: IV infusion
Total Duration of Study Intervention: 25 Weeks |
| Comparator Agent |
Not Applicable |
Not Applicable |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Female |
| Details |
AGE:
1.18 years of age and above, at the time of signing the informed consent.
TYPE OF PATIENT AND DISEASE CHARACTERISTICS
2. Documented case of dMMR/MSI-H recurrent or advanced EC that has progressed on or following prior treatment with platinum containing regimen.
3. Eligible for dostarlimab treatment according to the approved prescribing information and the investigator’s clinical judgement.
4. WOCBP (Women of childbearing potential) agree to use contraceptive from screening through at least 120 days after the last dose.
5. Negative serum or urine pregnancy test at most 72 hours prior to the first dose of study medication.
INFORMED CONSENT
6. Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the ICF and in this protocol, in accordance with applicable laws. |
|
| ExclusionCriteria |
| Details |
Medical conditions
1. Known active hepatic disease, ESRD or known case of serious, uncontrolled medical disorder/active infections which precludes participant inclusion in the study as per the investigators judgement.
2. Either the history of hypersensitivity to excipients of the study drug or to drugs with a similar chemical structure or class of the study drug.
Prior/Concomitant therapy
3. Received prior therapy with an anti- programmed death receptor 1 (anti-PD-1), anti-PD-1- ligand-1 (anti-PD-L1) agent.
4. Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of study treatment.
5. Received a live vaccine within 14 days of planned start of study therapy.
Prior/Concurrent clinical study experience
6. Participation in another clinical study with a study drug administered in the last 3 months.
Diagnostic assessments
7. Pregnant, breastfeeding, or expecting to conceive while receiving study treatment and for up to 120 days after the last dose of study treatment.
Other exclusion criteria
8. Judgment by the investigator that the patient should not participate in the study if the patient is unlikely to comply with study procedures, restrictions, and requirements. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Proportion of incidence of Grade 3 or greater TEAEs up to 25 weeks |
weeks 25 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Incidence of TEAEs up to 25 weeks.
2. Incidence of SAEs, related AEs and SAEs,
fatal AEs, non-fatal SAEs, AEs leading to
discontinuation of treatment, AEs leading to death, AEs leading to withdrawal and dose modification up to 25 weeks.
3. Change in laboratory parameters (hematology and clinical chemistry), vital signs and ECG from baseline at week 25. |
Weeks 25 |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
18/09/2025 |
| 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)
|
Not Applicable |
| 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 current Phase 4 study has been planned with the objective to evaluate the safety profile of dostarlimab treatment in adult patients in India with dMMR/MSI-H recurrent or advanced EC that had progressed on or following prior treatment with a platinum-containing regimen over the 25 weeks (175 days) of study participation by assessing the incidence of TEAEs and proportion of SAEs and possible TEAEs leading to death, dose modification, or treatment discontinuation. |