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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT05855200
Registration number
NCT05855200
Ethics application status
Date submitted
3/05/2023
Date registered
11/05/2023
Titles & IDs
Public title
Study of Perioperative Dostarlimab in Participants With Untreated T4N0 or Stage III dMMR/MSI-H Resectable Colon Cancer
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Scientific title
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
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Secondary ID [1]
0
0
2023-503265-27-00
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Secondary ID [2]
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0
219606
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Universal Trial Number (UTN)
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Trial acronym
AZUR-2
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Colonic Neoplasms
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0
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Neoplasms, Colon
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0
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Condition category
Condition code
Cancer
0
0
0
0
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Bowel - Back passage (rectum) or large bowel (colon)
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Other - Dostarlimab
Treatment: Drugs - CAPEOX
Treatment: Drugs - FOLFOX
Experimental: Dostarlimab - Participants will receive Dostarlimab pre and post surgery
Active comparator: Standard of Care (SOC) - Participants will receive SOC (FOLFOX/CAPEOX) or undergo expectant observation post surgery.
Treatment: Other: Dostarlimab
Dostarlimab will be administered.
Treatment: Drugs: CAPEOX
CAPEOX will be administered.
Treatment: Drugs: FOLFOX
FOLFOX will be administered.
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Intervention code [1]
0
0
Treatment: Other
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Intervention code [2]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Event-free Survival (EFS) Assessed by Blinded Independent Central Review (BICR)
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Assessment method [1]
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EFS is defined as the time from randomization to either disease recurrence or death due to any cause or treatment related toxicity that results in the participant not being suitable for surgery
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Timepoint [1]
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Up to approximately 5 years
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Secondary outcome [1]
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Overall Survival (OS)
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Assessment method [1]
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OS is defined as time from randomization to death from any cause
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Timepoint [1]
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Up to approximately 5 years
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Secondary outcome [2]
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Number of Participants with Pathological Response
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Assessment method [2]
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Pathological response will be categorized as a complete pathologic response, major pathologic response, partial pathologic response, or negligible pathologic response.
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Timepoint [2]
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Up to approximately 5 years
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Secondary outcome [3]
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Event-free Survival (EFS) assessed by local assessment
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Assessment method [3]
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EFS is defined as the time from randomization to either disease recurrence or death due to any cause or treatment related toxicity that results in the participant not being suitable for surgery
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Timepoint [3]
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Up to approximately 5 years
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Secondary outcome [4]
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Number of Participants with treatment emergent adverse events (AEs), serious adverse events (SAEs), Immune-mediated Adverse Event (imAEs), AEs leading to death and AEs leading to discontinuation of study treatment
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Assessment method [4]
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0
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Timepoint [4]
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Up to approximately 5 years
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Secondary outcome [5]
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Number of Participants with AEs and SAEs by Severity
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Assessment method [5]
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0
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Timepoint [5]
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Up to approximately 5 years
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Secondary outcome [6]
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Serum Concentration of Dostarlimab
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Assessment method [6]
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0
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Timepoint [6]
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Predose and End of Infusion (EoI) of Cycle 1 and EoI of Cycle 2 to Cycle 10 (each cycle is of 21 days)
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Secondary outcome [7]
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Serum Concentration of Dostarlimab at End of Infusion (C-EoI)
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Assessment method [7]
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0
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Timepoint [7]
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End of Infusion (EoI) of Cycle 1 to Cycle 10 (each cycle is of 21 days)
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Secondary outcome [8]
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Serum Predose trough concentration (Ctrough) of Dostarlimab
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Assessment method [8]
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0
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Timepoint [8]
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Predose of Cycle 1 to Cycle 10 (each cycle is of 21 days)
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Secondary outcome [9]
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Number of Participants with Anti-Drug Antibodies against Dostarlimab
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Assessment method [9]
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Timepoint [9]
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Up to approximately 5 years
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Eligibility
Key inclusion criteria
* Has untreated pathologically confirmed colon adenocarcinoma
* Has resectable colon adenocarcinoma defined as clinically T4N0 or Stage III
* Has radiologically evaluable disease
* Has a tumor demonstrating the presence of either dMMR status or MSI-H
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
* Has distant metastatic disease.
* Has received prior medical therapy (chemotherapy, immunotherapy, biologic, or targeted therapy), radiation therapy or surgery for management of colon cancer
* Has a tumor that, in the investigator's judgment is causing symptomatic bowel obstruction or otherwise requires urgent/emergent surgery
* Has undergone any major surgical procedure, open biopsy, or experienced significant traumatic injury within 28 days prior to randomization
* Has any history of interstitial lung disease or pneumonitis
* Has cirrhosis or current unstable liver or biliary disease per investigator assessment defined by the presence of ascites, encephalopathy, coagulopathy, hypoalbuminemia, esophageal/gastric varices, or persistent jaundice
* Has a history of allogenic stem cell transplantation or organ transplantation
* 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
* Is pregnant, breastfeeding, or expecting to conceive children within the projected duration of the study
* 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, or any components of FOLFOX or CAPEOX
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/08/2023
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
25/12/2030
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Actual
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Sample size
Target
711
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
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Recruitment hospital [1]
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GSK Investigational Site - Heidelberg
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GSK Investigational Site - Melbourne
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GSK Investigational Site - Newcastle
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Recruitment hospital [4]
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GSK Investigational Site - St Leonards
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Recruitment hospital [5]
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GSK Investigational Site - Woolangabba
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Recruitment postcode(s) [1]
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3084 - Heidelberg
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Recruitment postcode(s) [2]
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VIC 3004 - Melbourne
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Recruitment postcode(s) [3]
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2298 - Newcastle
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Recruitment postcode(s) [4]
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2065 - St Leonards
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Recruitment postcode(s) [5]
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4102 - Woolangabba
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Recruitment outside Australia
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Japan
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State/province [121]
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Shizuoka
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Japan
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Tokyo
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Korea, Republic of
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Daegu
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Korea, Republic of
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Gyeonggi-do
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Korea, Republic of
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Seoul
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Mexico
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DF
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Mexico
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Guadalajara
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Mexico
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Mexico City
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Mexico
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Oaxaca
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Mexico
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San Pedro Garza Garcia
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Mexico
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Tijuana
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Netherlands
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Breda
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Netherlands
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Maastricht
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Nijmegen
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Utrecht
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Norway
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Bergen
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Drammen
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Norway
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Kristiansand
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Norway
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Lrenskog
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Norway
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Oslo
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Norway
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Stavanger
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Norway
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Tromsoe
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Panama
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Punta Pacifica Panama City Panama
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Portugal
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Almada
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Portugal
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Coimbra
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Portugal
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Lisboa
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Spain
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BaracaldoVizcaya
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Spain
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Barcelona
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Spain
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COrdoba
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Spain
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Elche Alicante
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Spain
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Granada
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Spain
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JaEn
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Spain
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L'Hospitalet De Llobrega
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Spain
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Las Palmas De Gran Canar
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Spain
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Madrid
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Spain
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MAlaga
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Oviedo
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Spain
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Pamplona
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San Sebastian
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Santander
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Spain
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Sevilla
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Valencia
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Spain
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Zaragoza
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Sweden
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Eskilstuna
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Sweden
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Goteborg
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Sweden
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Linkoping
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Sweden
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Malmo
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Sweden
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Stockholm
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Sweden
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Umea
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Sweden
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Uppsala
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Kaohsiung
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Tainan
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Taipei
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Taoyuan
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Turkey
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Ankara
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Turkey
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Istanbul
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United Kingdom
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Birmingham
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United Kingdom
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Chelmsford
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United Kingdom
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Cheltenham
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United Kingdom
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Edinburgh
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United Kingdom
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Hull
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United Kingdom
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Leeds West Yorkshire
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United Kingdom
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London
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United Kingdom
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Manchester
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United Kingdom
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Sutton
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
GlaxoSmithKline
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Address
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Ethics approval
Ethics application status
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Summary
Brief summary
The primary purpose of this study is to evaluate the efficacy of perioperative dostarlimab compared with standard of care (SOC) in participants with untreated T4N0 or Stage III (resectable), defective mismatch repair/ microsatellite instability high (dMMR/MSI-H) colon cancer.
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Trial website
https://clinicaltrials.gov/study/NCT05855200
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
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GSK Clinical Trials
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Address
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GlaxoSmithKline
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Contact person for public queries
Name
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US GSK Clinical Trials Call Center
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Address
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Phone
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877-379-3718
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[email protected]
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Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
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What data in particular will be shared?
Qualified researchers may request access to anonymized individual patient-level data (IPD) and related study documents of the eligible studies via the Data Sharing Portal. Details on GSK's data sharing criteria can be found at: https://www.gsk.com/en-gb/innovation/trials/data-transparency/
Supporting document/s available: Study protocol, Statistical analysis plan (SAP), Informed consent form (ICF), Clinical study report (CSR)
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When will data be available (start and end dates)?
Anonymized IPD will be made available within 6 months of publication of primary, key secondary and safety results for studies in product with approved indication(s) or terminated asset(s) across all indications.
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Available to whom?
Anonymized IPD is shared with researchers whose proposals are approved by an Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension may be granted, when justified, for up to 6 months.
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Available for what types of analyses?
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How or where can data be obtained?
IPD available at link: https://www.gsk.com/en-gb/innovation/trials/data-transparency/
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What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT05855200