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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
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
Secondary ID [1] 0 0
2023-503265-27-00
Secondary ID [2] 0 0
219606
Universal Trial Number (UTN)
Trial acronym
AZUR-2
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Colonic Neoplasms 0 0
Neoplasms, Colon 0 0
Condition category
Condition code
Cancer 0 0 0 0
Bowel - Back passage (rectum) or large bowel (colon)

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 0 0
Treatment: Other
Intervention code [2] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Event-free Survival (EFS) Assessed by Blinded Independent Central Review (BICR)
Timepoint [1] 0 0
Up to approximately 5 years
Secondary outcome [1] 0 0
Overall Survival (OS)
Timepoint [1] 0 0
Up to approximately 5 years
Secondary outcome [2] 0 0
Number of Participants with Pathological Response
Timepoint [2] 0 0
Up to approximately 5 years
Secondary outcome [3] 0 0
Event-free Survival (EFS) assessed by local assessment
Timepoint [3] 0 0
Up to approximately 5 years
Secondary outcome [4] 0 0
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
Timepoint [4] 0 0
Up to approximately 5 years
Secondary outcome [5] 0 0
Number of Participants with AEs and SAEs by Severity
Timepoint [5] 0 0
Up to approximately 5 years
Secondary outcome [6] 0 0
Serum Concentration of Dostarlimab
Timepoint [6] 0 0
Predose and End of Infusion (EoI) of Cycle 1 and EoI of Cycle 2 to Cycle 10 (each cycle is of 21 days)
Secondary outcome [7] 0 0
Serum Concentration of Dostarlimab at End of Infusion (C-EoI)
Timepoint [7] 0 0
End of Infusion (EoI) of Cycle 1 to Cycle 10 (each cycle is of 21 days)
Secondary outcome [8] 0 0
Serum Predose trough concentration (Ctrough) of Dostarlimab
Timepoint [8] 0 0
Predose of Cycle 1 to Cycle 10 (each cycle is of 21 days)
Secondary outcome [9] 0 0
Number of Participants with Anti-Drug Antibodies against Dostarlimab
Timepoint [9] 0 0
Up to approximately 5 years

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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/08/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
25/12/2030
Actual
Sample size
Target
711
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
GSK Investigational Site - Heidelberg
Recruitment hospital [2] 0 0
GSK Investigational Site - Melbourne
Recruitment hospital [3] 0 0
GSK Investigational Site - Newcastle
Recruitment hospital [4] 0 0
GSK Investigational Site - St Leonards
Recruitment hospital [5] 0 0
GSK Investigational Site - Woolangabba
Recruitment postcode(s) [1] 0 0
3084 - Heidelberg
Recruitment postcode(s) [2] 0 0
VIC 3004 - Melbourne
Recruitment postcode(s) [3] 0 0
2298 - Newcastle
Recruitment postcode(s) [4] 0 0
2065 - St Leonards
Recruitment postcode(s) [5] 0 0
4102 - Woolangabba
Recruitment outside Australia
Country [1] 0 0
United States of America
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Arizona
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California
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Connecticut
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Michigan
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Missouri
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Nebraska
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Tallinn
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Tartu
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Helsinki
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Toulouse Cedex 9
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Punta Pacifica Panama City Panama
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Chelmsford
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Hull
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Leeds West Yorkshire
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Manchester
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Sutton

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
GlaxoSmithKline
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
GSK Clinical Trials
Address 0 0
GlaxoSmithKline
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
US GSK Clinical Trials Call Center
Address 0 0
Country 0 0
Phone 0 0
877-379-3718
Fax 0 0
Email 0 0
GSKClinicalSupportHD@gsk.com
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
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)
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.
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.
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: https://www.gsk.com/en-gb/innovation/trials/data-transparency/


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