| CTRI Number |
CTRI/2025/07/092011 [Registered on: 30/07/2025] Trial Registered Prospectively |
| Last Modified On: |
09/12/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Phase 3 Study of Perioperative Dostarlimab in Participants with Untreated T4N0 or Stage III dMMR/MSI-H Resectable Colon Cancer |
|
Scientific Title of Study
|
A Phase 3, Open-Label, Randomized Study of Perioperative Dostarlimab Monotherapy versus Standard of Care in Participants with Untreated T4N0 or Stage III dMMR/MSI-H Resectable Colon Cancer |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Protocol no.: 219606 amendment 4, dated 22-AUG-2024 |
Protocol Number |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Modification(s)
|
| Name |
Dr Gaurav Deshmukh |
| Designation |
Senior Medical Manager, Gynaecological Oncology, Medical Affairs |
| Affiliation |
GSK Pharma India Private Limited |
| Address |
GlaxoSmithKline Pharmaceuticals Limited, 252, Dr. Annie Besant Road, Worli, Mumbai-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 |
Senior Medical Manager, Gynaecological Oncology, Medical Affairs |
| Affiliation |
GSK Pharma India Private Limited |
| Address |
GlaxoSmithKline Pharmaceuticals Limited, 252, Dr. Annie Besant Road, Worli, Mumbai-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
400030
India |
| Phone |
9821415224 |
| Fax |
|
| Email |
swapnali.a.raut@gsk.com |
|
|
Source of Monetary or Material Support
|
| GSK Pharma India Private Limited C/O GlaxoSmithKline Pharmaceuticals Limited Dr. Annie Besant Road, Worli, Mumbai, - 400030, India. |
|
|
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
|
| Name |
Address |
| GSK Pharma India Private Limited |
01, Battery House Bhulabhai Desai Road, Mumbai, Maharashtra (India) - 400026 |
|
|
Countries of Recruitment
|
Argentina
Australia
Belgium
Brazil
Canada
China
Estonia
Finland
France
Germany
Greece
India
Italy
Japan
Mexico
Netherlands
Norway
Panama
Portugal
Spain
Sweden
Taiwan
Turkey
United Kingdom
United States of America
Democratic People's Republic of Korea |
Sites of Study
Modification(s)
|
| No of Sites = 9 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr MVT Krishna Mohan |
Basavatarakam Indo American Cancer Hospital & Research Institute |
Department of Clinical Trials, Road No 10, Banjara Hills, Hyderabad-500034, Telangana, India.
Hyderabad
TELANGANA |
9866154503
mvtkm@yahoo.com |
| Dr Kalyan Kusum Mukherjee |
Chittaranjan National Cancer Institute (CNCI) |
Room No 303, 3rd Floor, Research Building, 37, S.P. Mukherjee Road, Kolkata-700026, West Bengal, India.
Kolkata
WEST BENGAL |
9830115905
kkmukherjee4u@hotmail.com |
| Dr Davinder Paul |
Fortis Hospital |
Department Medical Oncology, Near Radha Swamy Satsang Bhavan, Mundian Kalan, Chandigarh Road
Ludhiana
PUNJAB |
7070345740
davinder.paul@FORTISHEALTHCARE.COM |
| Dr Niti Raizada |
Fortis Hospital |
Room No 705, Clinical Research Department, 154/9, Bannerghatta Road, Opposite IIM-B, Bengaluru, Karnataka-560076.
Bangalore
KARNATAKA |
9901205647
oncologistniti@gmail.com |
| Dr Mukesh Chaudhari |
HCG Manavata Cancer Centre |
Department Medical Oncology, Manavata Health Campus, Mumbai Naka,422004
Nashik
MAHARASHTRA |
9822574157
drmukesh@mcrinasik.com |
| Dr Minish Jain |
Inamdar Multispeciality Hospital |
Oncology Department, SN 15, Fatimanagar , Vitthalrao Shivarkarmarg , Fatima Nagar, Wanawai Pune 411040
Pune
MAHARASHTRA |
9823133390
minishjain009@gmail.com |
| Dr Smita Kayal |
Jawaharlal Institute of Postgraduate Medical Education and Research (JIPMER) |
Department/Division Medical Oncology, Gorimedu, Dhanvantari Nagar, Puducherry, 605006.
Pondicherry
PONDICHERRY |
7598118439
kayalsmita@gmail.com |
| Dr Rohan Bhise |
KLES Dr Prabhakar Kore Hospital and MRC |
Site Management Office, Second Floor, Sarawati Ward, Nehru Nagar, Belgaum-590010, Karnataka, India Belgaum
Belgaum
KARNATAKA |
9448866712
rohanbhise30@gmail.com |
| Dr Anant Ramaswamy |
Tata Memorial Hospital |
Department Medical Oncology, Dr. E Borges Road, Parel, Mumbai, Maharashtra 400012.
Mumbai
MAHARASHTRA |
9833034802
anantr13@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 9 |
| Name of Committee |
Approval Status |
| Ethics Committee Inamdar Multispeciality Hospital CIMETs Inamdar Mutispeciality Hospital. Hospital Building S.No .15,Fatima Nagar ,Wanawadi. Pune Pune Maharashtra - 411040 India |
Approved |
| Fortis Hospital Ethics Committee Fortis Hospital Ltd 154/9, Bannerghatta Road Opp To IIM-B Bangalore Bengaluru (Bangalore) Urban Karnataka - 560076 India |
Approved |
| Institutional Ethics Committee Chittaranjan National Cancer Institute 37, S.P Mukherjee Road.Kolkata-700026. West Bengal, India |
Submittted/Under Review |
| Institutional Ethics Committee Fortis Hospital, Mundian Khurd, Ludhiana, Punjab - 141015 India |
Approved |
| Institutional Ethics Committee Intervention Studies JIPMER, Dhanvantri Nagar Pondicherry, Pondicherry- 605006, India |
Submittted/Under Review |
| Institutional Ethics Committee KLE University KLE Dr P K Hospital and MRC JNMC Campus Nehru Nagar Belagavi 590010 Karnataka India |
Approved |
| Institutional ethics Committee, Basavatarakam Indo American Cancer Hospital & research Institute, Road No 10, Banjara hills,Hyderabad - 500034,Telangana,India |
Approved |
| ManavataClinicalResearchInstitute Ethics Committee HCG Manavata Cancer Centre Behind Shivang Auto Mumbai Naka Nashik Nashik Maharashtra - 422002 India |
Approved |
| TMH, Institutional Ethics Commitee-I, Tatat Memorial Hospital, Dr. E.Borges Road Parel Mumbai Mumbai City Maharashrea - 400012 India |
Submittted/Under Review |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C189||Malignant neoplasm of colon, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
CAPEOX for 3 or 6 months, or FOLFOX for 6 months |
Type - Biologic
Dose Formulation - CAPEOX: Solution for infusion and oral agent, FOLFOX: Solution for infusion and injectable
Unit dose strength - CAPEOX:
Oxaliplatin: 130 mg/m2 (5 mg/mL) IV infusion
Capecitabine: 1000 mg/m² oral agent
FOLFOX:
Levoleucovorin 200 mg/m2 IV infusion OR
Leucovorin 400 mg/m2 IV infusion
Oxaliplatin 85 mg/m2 IV infusion
Fluorouracil (5FU):
400 mg/m2 IV bolus
-1200 mg/m2/day IV infusion (Total 2400 mg/m2)
Route of administration - IV infusion, injectable and/or oral
Dosage level - CAPEOX
Capecitabine: Oral administration twice-a-day for 14 days of a 21-day Cycle
Oxaliplatin: IV infusion over 2 hours on day 1 of a 21-day Cycle
mFOLFOX6:
Oxaliplatin: IV Infusion over 2 hours on Day 1 of a 14-day Cycle
Leucovorin or Levoleucovorin: IV infusion over 2 hours on Day 1 of 14-day Cycle
5-FU:
IV bolus over 2 minutes on day 1 of a 14-day Cycle, followed by IV continuous infusion 1200 mg/m2/day x2 days (total 2400 mg/m2 over 46-48 hours)
Number of doses - CAPEOX: 4 or 8, FOLFOX: 12 |
| Intervention |
Dostarlimab |
Type - Biologic
Dose Formulation - Solutiom for Infusion
Unit DOse Strength - 500 mg Q3W for 4 Cycles before surgery and 1000 mg Q6W for 6 Cycles after surgery
ROA - IV Infusion
Dosage Level - Administer via a 30-minutea IV infusion at a dose of 500 mg Q3W for 4 Cycles (Period 1) and 1000 mg Q6W for 6 Cycles after surgery (Period 2)
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
Confirmed Colon Adenocarcinoma
Resectable colon adenocarcinoma clinically T4N0 or Stage 3
Radiologically evaluable disease
Tumor demonstrating the presence of either -MMR status must be assessed by IHC for MMR protein expression (MLH1, 2, 6 and PMS2)
MSi-H phenotype as determined by PCR or by tissue NGS, MSI-H determined by local Laboratory
ECOG PS of 0 or 1
Provide tissue sample from initial diagnosis
adequate organ function |
|
| ExclusionCriteria |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate the efficacy of perioperative dostarlimab compared with SOC in participants with untreated T4N0 or Stage III(resectable), dMMR/MSI-H colon cancer |
EFS with recurrence assessed by BICR Where an event is defined as:
1-Disease recurrence based on radiological assessment by BICR o Disease progression precluding surgery (local assessment).
2-Disease recurrence based on a pathological assessment of new lesions (local assessment).
3-Death due to any cause o Treatment-related toxicity that results in the participant not being suitable for surgery |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To further evaluate the efficacy of perioperative dostarlimab compared with SOC in participants with untreated T4N0 or Stage III (resectable), dMMR/MSI-H colon cancer. |
OS, defined as time from randomization to death from any cause |
| To evaluate the efficacy of neoadjuvant dostarlimab in participants with untreated T4N0 or Stage III (resectable), dMMR/MSI-H colon cancer |
Whenever there is a Pathological response determined by local assessment. |
| To evaluate the efficacy of perioperative dostarlimab compared with SOC in participants with untreated T4N0 or Stage III (resectable), dMMR/MSI-H colon cancer |
EFS event with recurrence evaluated by local assessment |
| To assess the safety & tolerability of dostarlimab compared with SOC in participants with untreated T4N0 or Stage III (resectable), dMMR/MSI-H colon cancer |
Whenever there are treatment emergent AEs SAEs imAEs & AEs leading to death or discontinuation of study intervention |
| To describe the PK of dostarlimab in participants with untreated T4N0 or Stage III (resectable), dMMR/MSI-H colon cancer |
Serum concentrations and relevant PK parameters (C-EoI and Ctrough) for dostarlimab |
| To determine the immunogenicity of dostarlimab in participants with untreated T4N0 or Stage III (resectable), dMMR/MSI-H colon cancer |
Incidence of ADA against dostarlimab |
|
|
Target Sample Size
|
Total Sample Size="711"
Sample Size from India="40"
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)
|
05/08/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
02/08/2023 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="6"
Months="3"
Days="1" |
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
|
Rationale: The purpose of this study is to investigate perioperative dostarlimab monotherapy versus SOC (physician choice of adjuvant FOLFOX or CAPEOX or Watch and Wait) in untreated participants with T4N0 or Stage III mismatch repair deficient (dMMR)/microsatellite instability-high (MSI-H) resectable colon cancer.
Overall Design: This is a global, Phase 3, open-label, multicenter, randomized study designed to evaluate the effect of perioperative dostarlimab monotherapy versus SOC (physician choice of adjuvant FOLFOX or CAPEOX or Watch and Wait) in participants with previously untreated T4N0 or Stage III dMMR/MSI-H, resectable colon cancer. The primary endpoint is EFS with recurrence assessed by BICR. The secondary endpoints comprise the assessment of pathological response, OS, EFS with recurrence evaluated by local assessment, safety and tolerability, PK and immunogenicity. All primary and secondary endpoints will be analyzed in all participants randomized in the study.
Number of Participants: Approximately 711 participants will be enrolled in this study. Independent data monitoring committee: An IDMC will provide an independent review and assessment of efficacy and safety data from the study to safeguard the interest and safety of study participants and to assess for continued benefit-risk ratio for study participants. |