Trial Review

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
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
Date last updated
27/08/2024

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
State/province [1] 0 0
Arizona
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Connecticut
Country [4] 0 0
United States of America
State/province [4] 0 0
District of Columbia
Country [5] 0 0
United States of America
State/province [5] 0 0
Florida
Country [6] 0 0
United States of America
State/province [6] 0 0
Georgia
Country [7] 0 0
United States of America
State/province [7] 0 0
Illinois
Country [8] 0 0
United States of America
State/province [8] 0 0
Kansas
Country [9] 0 0
United States of America
State/province [9] 0 0
Kentucky
Country [10] 0 0
United States of America
State/province [10] 0 0
Louisiana
Country [11] 0 0
United States of America
State/province [11] 0 0
Maryland
Country [12] 0 0
United States of America
State/province [12] 0 0
Michigan
Country [13] 0 0
United States of America
State/province [13] 0 0
Minnesota
Country [14] 0 0
United States of America
State/province [14] 0 0
Missouri
Country [15] 0 0
United States of America
State/province [15] 0 0
Nebraska
Country [16] 0 0
United States of America
State/province [16] 0 0
New Hampshire
Country [17] 0 0
United States of America
State/province [17] 0 0
New York
Country [18] 0 0
United States of America
State/province [18] 0 0
North Carolina
Country [19] 0 0
United States of America
State/province [19] 0 0
Ohio
Country [20] 0 0
United States of America
State/province [20] 0 0
Oklahoma
Country [21] 0 0
United States of America
State/province [21] 0 0
Pennsylvania
Country [22] 0 0
United States of America
State/province [22] 0 0
South Dakota
Country [23] 0 0
United States of America
State/province [23] 0 0
Tennessee
Country [24] 0 0
United States of America
State/province [24] 0 0
Texas
Country [25] 0 0
United States of America
State/province [25] 0 0
Virginia
Country [26] 0 0
United States of America
State/province [26] 0 0
Wisconsin
Country [27] 0 0
Argentina
State/province [27] 0 0
Buenos Aires
Country [28] 0 0
Argentina
State/province [28] 0 0
Capital Federal
Country [29] 0 0
Argentina
State/province [29] 0 0
Ciudad Autonoma de Buenos Aire
Country [30] 0 0
Argentina
State/province [30] 0 0
Cordoba
Country [31] 0 0
Argentina
State/province [31] 0 0
Mar del Plata
Country [32] 0 0
Argentina
State/province [32] 0 0
Rosario
Country [33] 0 0
Argentina
State/province [33] 0 0
Santa Fe
Country [34] 0 0
Belgium
State/province [34] 0 0
Aalst
Country [35] 0 0
Belgium
State/province [35] 0 0
Bruxelles
Country [36] 0 0
Belgium
State/province [36] 0 0
Edegem
Country [37] 0 0
Belgium
State/province [37] 0 0
Gent
Country [38] 0 0
Belgium
State/province [38] 0 0
Leuven
Country [39] 0 0
Belgium
State/province [39] 0 0
LiEge
Country [40] 0 0
Belgium
State/province [40] 0 0
Roeselare
Country [41] 0 0
Brazil
State/province [41] 0 0
Barretos
Country [42] 0 0
Brazil
State/province [42] 0 0
Lages
Country [43] 0 0
Brazil
State/province [43] 0 0
Natal
Country [44] 0 0
Brazil
State/province [44] 0 0
Porto Alegre
Country [45] 0 0
Brazil
State/province [45] 0 0
Salvador
Country [46] 0 0
Brazil
State/province [46] 0 0
Sao Jose do Rio Preto
Country [47] 0 0
Brazil
State/province [47] 0 0
Sao Paulo
Country [48] 0 0
Brazil
State/province [48] 0 0
Teresina
Country [49] 0 0
Brazil
State/province [49] 0 0
VitOria
Country [50] 0 0
Canada
State/province [50] 0 0
Edmonton
Country [51] 0 0
Canada
State/province [51] 0 0
Halifax
Country [52] 0 0
Canada
State/province [52] 0 0
Montreal
Country [53] 0 0
Canada
State/province [53] 0 0
Ottawa
Country [54] 0 0
Canada
State/province [54] 0 0
Toronto
Country [55] 0 0
China
State/province [55] 0 0
Beijing
Country [56] 0 0
China
State/province [56] 0 0
Changchun
Country [57] 0 0
China
State/province [57] 0 0
Changsha
Country [58] 0 0
China
State/province [58] 0 0
Chengdu
Country [59] 0 0
China
State/province [59] 0 0
Chongqing
Country [60] 0 0
China
State/province [60] 0 0
Guangzhou
Country [61] 0 0
China
State/province [61] 0 0
Hangzhou
Country [62] 0 0
China
State/province [62] 0 0
Harbin
Country [63] 0 0
China
State/province [63] 0 0
Jinan
Country [64] 0 0
China
State/province [64] 0 0
Kunming
Country [65] 0 0
China
State/province [65] 0 0
Meizhou
Country [66] 0 0
China
State/province [66] 0 0
Nanchang
Country [67] 0 0
China
State/province [67] 0 0
Shanghai
Country [68] 0 0
China
State/province [68] 0 0
Shenyang
Country [69] 0 0
China
State/province [69] 0 0
Shenzhen
Country [70] 0 0
China
State/province [70] 0 0
Taiyuan
Country [71] 0 0
China
State/province [71] 0 0
Tianjin
Country [72] 0 0
China
State/province [72] 0 0
Wuhan
Country [73] 0 0
China
State/province [73] 0 0
Xiamen
Country [74] 0 0
China
State/province [74] 0 0
Yangzhou
Country [75] 0 0
China
State/province [75] 0 0
Zhengzhou
Country [76] 0 0
Estonia
State/province [76] 0 0
Tallinn
Country [77] 0 0
Estonia
State/province [77] 0 0
Tartu
Country [78] 0 0
Finland
State/province [78] 0 0
Helsinki
Country [79] 0 0
Finland
State/province [79] 0 0
Tampere
Country [80] 0 0
Finland
State/province [80] 0 0
Turku
Country [81] 0 0
France
State/province [81] 0 0
Lyon
Country [82] 0 0
France
State/province [82] 0 0
Marseille Cedex 5
Country [83] 0 0
France
State/province [83] 0 0
Nantes cedex 1
Country [84] 0 0
France
State/province [84] 0 0
Paris
Country [85] 0 0
France
State/province [85] 0 0
Pessac cedex
Country [86] 0 0
France
State/province [86] 0 0
Rennes Cedex
Country [87] 0 0
France
State/province [87] 0 0
Rouen Cedex
Country [88] 0 0
France
State/province [88] 0 0
Saint-Priest en Jarez
Country [89] 0 0
France
State/province [89] 0 0
Suresnes
Country [90] 0 0
France
State/province [90] 0 0
Toulouse Cedex 9
Country [91] 0 0
France
State/province [91] 0 0
Villejuif Cedex
Country [92] 0 0
Germany
State/province [92] 0 0
Berlin
Country [93] 0 0
Germany
State/province [93] 0 0
Duesseldorf
Country [94] 0 0
Germany
State/province [94] 0 0
Frankfurt
Country [95] 0 0
Germany
State/province [95] 0 0
Halle
Country [96] 0 0
Germany
State/province [96] 0 0
Luebeck
Country [97] 0 0
Germany
State/province [97] 0 0
Mannheim
Country [98] 0 0
Germany
State/province [98] 0 0
MUnchen
Country [99] 0 0
Germany
State/province [99] 0 0
Munchen
Country [100] 0 0
Greece
State/province [100] 0 0
Athens
Country [101] 0 0
Greece
State/province [101] 0 0
Thessaloniki
Country [102] 0 0
Italy
State/province [102] 0 0
Cagliari
Country [103] 0 0
Italy
State/province [103] 0 0
Genova
Country [104] 0 0
Italy
State/province [104] 0 0
Milano
Country [105] 0 0
Italy
State/province [105] 0 0
Napoli
Country [106] 0 0
Italy
State/province [106] 0 0
Padova
Country [107] 0 0
Italy
State/province [107] 0 0
Pisa
Country [108] 0 0
Italy
State/province [108] 0 0
Reggio Emilia
Country [109] 0 0
Italy
State/province [109] 0 0
Roma
Country [110] 0 0
Italy
State/province [110] 0 0
Rozzano MI
Country [111] 0 0
Japan
State/province [111] 0 0
Aichi
Country [112] 0 0
Japan
State/province [112] 0 0
Chiba
Country [113] 0 0
Japan
State/province [113] 0 0
Fukuoka
Country [114] 0 0
Japan
State/province [114] 0 0
Hokkaido
Country [115] 0 0
Japan
State/province [115] 0 0
Hyogo
Country [116] 0 0
Japan
State/province [116] 0 0
Ibaraki
Country [117] 0 0
Japan
State/province [117] 0 0
Kanagawa
Country [118] 0 0
Japan
State/province [118] 0 0
Kyoto
Country [119] 0 0
Japan
State/province [119] 0 0
Okayama
Country [120] 0 0
Japan
State/province [120] 0 0
Osaka
Country [121] 0 0
Japan
State/province [121] 0 0
Shizuoka
Country [122] 0 0
Japan
State/province [122] 0 0
Tokyo
Country [123] 0 0
Korea, Republic of
State/province [123] 0 0
Daegu
Country [124] 0 0
Korea, Republic of
State/province [124] 0 0
Gyeonggi-do
Country [125] 0 0
Korea, Republic of
State/province [125] 0 0
Seoul
Country [126] 0 0
Mexico
State/province [126] 0 0
DF
Country [127] 0 0
Mexico
State/province [127] 0 0
Guadalajara
Country [128] 0 0
Mexico
State/province [128] 0 0
Mexico City
Country [129] 0 0
Mexico
State/province [129] 0 0
Oaxaca
Country [130] 0 0
Mexico
State/province [130] 0 0
San Pedro Garza Garcia
Country [131] 0 0
Mexico
State/province [131] 0 0
Tijuana
Country [132] 0 0
Netherlands
State/province [132] 0 0
Breda
Country [133] 0 0
Netherlands
State/province [133] 0 0
Maastricht
Country [134] 0 0
Netherlands
State/province [134] 0 0
Nijmegen
Country [135] 0 0
Netherlands
State/province [135] 0 0
Utrecht
Country [136] 0 0
Norway
State/province [136] 0 0
Bergen
Country [137] 0 0
Norway
State/province [137] 0 0
Drammen
Country [138] 0 0
Norway
State/province [138] 0 0
Kristiansand
Country [139] 0 0
Norway
State/province [139] 0 0
Lrenskog
Country [140] 0 0
Norway
State/province [140] 0 0
Oslo
Country [141] 0 0
Norway
State/province [141] 0 0
Stavanger
Country [142] 0 0
Norway
State/province [142] 0 0
Tromsoe
Country [143] 0 0
Panama
State/province [143] 0 0
Punta Pacifica Panama City Panama
Country [144] 0 0
Portugal
State/province [144] 0 0
Almada
Country [145] 0 0
Portugal
State/province [145] 0 0
Coimbra
Country [146] 0 0
Portugal
State/province [146] 0 0
Lisboa
Country [147] 0 0
Spain
State/province [147] 0 0
BaracaldoVizcaya
Country [148] 0 0
Spain
State/province [148] 0 0
Barcelona
Country [149] 0 0
Spain
State/province [149] 0 0
COrdoba
Country [150] 0 0
Spain
State/province [150] 0 0
Elche Alicante
Country [151] 0 0
Spain
State/province [151] 0 0
Granada
Country [152] 0 0
Spain
State/province [152] 0 0
JaEn
Country [153] 0 0
Spain
State/province [153] 0 0
L'Hospitalet De Llobrega
Country [154] 0 0
Spain
State/province [154] 0 0
Las Palmas De Gran Canar
Country [155] 0 0
Spain
State/province [155] 0 0
Madrid
Country [156] 0 0
Spain
State/province [156] 0 0
MAlaga
Country [157] 0 0
Spain
State/province [157] 0 0
Oviedo
Country [158] 0 0
Spain
State/province [158] 0 0
Pamplona
Country [159] 0 0
Spain
State/province [159] 0 0
San Sebastian
Country [160] 0 0
Spain
State/province [160] 0 0
Santander
Country [161] 0 0
Spain
State/province [161] 0 0
Sevilla
Country [162] 0 0
Spain
State/province [162] 0 0
Valencia
Country [163] 0 0
Spain
State/province [163] 0 0
Zaragoza
Country [164] 0 0
Sweden
State/province [164] 0 0
Eskilstuna
Country [165] 0 0
Sweden
State/province [165] 0 0
Goteborg
Country [166] 0 0
Sweden
State/province [166] 0 0
Linkoping
Country [167] 0 0
Sweden
State/province [167] 0 0
Malmo
Country [168] 0 0
Sweden
State/province [168] 0 0
Stockholm
Country [169] 0 0
Sweden
State/province [169] 0 0
Umea
Country [170] 0 0
Sweden
State/province [170] 0 0
Uppsala
Country [171] 0 0
Taiwan
State/province [171] 0 0
Kaohsiung
Country [172] 0 0
Taiwan
State/province [172] 0 0
Tainan
Country [173] 0 0
Taiwan
State/province [173] 0 0
Taipei
Country [174] 0 0
Taiwan
State/province [174] 0 0
Taoyuan
Country [175] 0 0
Turkey
State/province [175] 0 0
Ankara
Country [176] 0 0
Turkey
State/province [176] 0 0
Istanbul
Country [177] 0 0
United Kingdom
State/province [177] 0 0
Birmingham
Country [178] 0 0
United Kingdom
State/province [178] 0 0
Chelmsford
Country [179] 0 0
United Kingdom
State/province [179] 0 0
Cheltenham
Country [180] 0 0
United Kingdom
State/province [180] 0 0
Edinburgh
Country [181] 0 0
United Kingdom
State/province [181] 0 0
Hull
Country [182] 0 0
United Kingdom
State/province [182] 0 0
Leeds West Yorkshire
Country [183] 0 0
United Kingdom
State/province [183] 0 0
London
Country [184] 0 0
United Kingdom
State/province [184] 0 0
Manchester
Country [185] 0 0
United Kingdom
State/province [185] 0 0
Sutton

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

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/study/NCT05855200
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
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT05855200