Study of Perioperative Dostarlimab in Participants With Untreated T4N0 or Stage III dMMR/MSI-H Resectable Colon Cancer

Last updated: August 23, 2024
Sponsor: GlaxoSmithKline
Overall Status: Active - Recruiting

Phase

3

Condition

Colorectal Cancer

Colon Cancer

Neoplasms

Treatment

CAPEOX

FOLFOX

Dostarlimab

Clinical Study ID

NCT05855200
219606
2023-503265-27-00
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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

Exclusion

Exclusion Criteria:

  • Has distant metastatic disease.

  • Has received prior medical therapy (chemotherapy, immunotherapy, biologic, ortargeted therapy), radiation therapy or surgery for management of colon cancer

  • Has a tumor that, in the investigator's judgment is causing symptomatic bowelobstruction or otherwise requires urgent/emergent surgery

  • Has undergone any major surgical procedure, open biopsy, or experienced significanttraumatic 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 investigatorassessment 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 experimentaltherapies (including but not limited to chemotherapy, radiation, hormonal treatment,antibody therapy, immunotherapy, gene therapy, vaccine therapy, or otherexperimental drugs) of any kind are permitted while the participant is receivingstudy intervention

  • Is pregnant, breastfeeding, or expecting to conceive children within the projectedduration of the study

  • Has a history of severe allergic and/or anaphylactic reactions to chimeric, human orhumanized antibodies, fusion proteins, or known allergies to dostarlimab, or itsexcipients, or any components of FOLFOX or CAPEOX

Study Design

Total Participants: 711
Treatment Group(s): 3
Primary Treatment: CAPEOX
Phase: 3
Study Start date:
August 01, 2023
Estimated Completion Date:
December 25, 2030

Connect with a study center

  • GSK Investigational Site

    Ciudad Autonoma de Buenos Aires, Buenos Aires C1181ACH
    Argentina

    Site Not Available

  • GSK Investigational Site

    Ciudad de Buenos Aires, Buenos Aires C1431FWO
    Argentina

    Site Not Available

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    Buenos Aires, 1093
    Argentina

    Active - Recruiting

  • GSK Investigational Site

    Capital Federal, C1426ANZ
    Argentina

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    Ciudad Autonoma de Buenos Aire, C1431FWO
    Argentina

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    Cordoba, 5000
    Argentina

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    Mar del Plata, 7600
    Argentina

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    Rosario, S2002
    Argentina

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    Santa Fe, S3000FUJ
    Argentina

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    Waratah, New South Wales 2298
    Australia

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    Woolloongabba, Queensland 4102
    Australia

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    Heidelberg, 3084
    Australia

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    Melbourne, VIC 3004
    Australia

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    Newcastle, 2298
    Australia

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    St Leonards, 2065
    Australia

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    Woolangabba, 4102
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    Aalst, 9300
    Belgium

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    Anderlecht, 1070
    Belgium

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    Bruxelles, 1200
    Belgium

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    Edegem, 2650
    Belgium

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    Gent, 9000
    Belgium

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    Leuven, 3000
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    LiEge, 4000
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    Liège, 4000
    Belgium

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    Roeselare, 8800
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    Vitória, Espírito Santo 29043-260
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    Chengdu, 610041
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    Chongqing, 400042
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    Harbin, 150000
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    Kunming, 650106
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    Nanchang, 330006
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    Nice Cedex 2, 06189
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    Leipzig, Sachsen 04103
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    MUnchen, 81377
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    Monserrato, Sardegna 09042
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    Milano, 20162
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    Padova, 35128
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    Aichi, 464-8681
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    Kyoto, 606-8507
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    Korea, Republic of

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    Gyeonggi-do, 463712
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    Seoul, 06591
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    Ciudad de México, Estado De México 03810
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    Oaxaca de Juarez, Oaxaca 68020
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    Ciudad de Mexico, 03103
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    DF, 14000
    Mexico

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    Guadalajara, 44280
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    Mexico, 14000
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    Mexico City, 03100
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    Oaxaca, 68020
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    San Pedro Garza Garcia, 66220
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    Tijuana, 22010
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    Breda, 4818 CK
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    Maastricht, 6229 HX
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    Nijmegen, 6525 GA
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    Utrecht, 3584 CX
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    Bergen, 5021
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    Drammen, N-3004
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    Kristiansand, 4604
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    Lrenskog, 1478
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    Lørenskog, 1478
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    Stavanger, 4011
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    Tromsoe, 9019
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    Tromsø, 9019
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    Panama,
    Panama

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    Punta Pacifica Panama City Panama,
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    Almada, 2805-267
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    Coimbra, 3000-075
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    Lisboa, 1649-035
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    Majadahonda, Madrid 28222
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    Baracaldo/Vizcaya, 48903
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    Elche Alicante, 03203
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    Granada, 18014
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    Hospitalet de Llobregat (Barcelona), 08908
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    Jaén, 23007
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    Madrid, 28050
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    Eskilstuna, 63349
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  • GSK Investigational Site

    Wexford, Pennsylvania 15090
    United States

    Site Not Available

  • GSK Investigational Site

    Wynnewood, Pennsylvania 19096
    United States

    Active - Recruiting

  • GSK Investigational Site

    Spartanburg, South Carolina 29307
    United States

    Site Not Available

  • GSK Investigational Site

    Aberdeen, South Dakota 57401
    United States

    Site Not Available

  • GSK Investigational Site

    Pierre, South Dakota 57501
    United States

    Site Not Available

  • GSK Investigational Site

    Sioux Falls, South Dakota 57105
    United States

    Active - Recruiting

  • GSK Investigational Site

    Yankton, South Dakota 57078
    United States

    Site Not Available

  • GSK Investigational Site

    Nashville, Tennessee 37232
    United States

    Active - Recruiting

  • GSK Investigational Site

    Dallas, Texas 75235
    United States

    Active - Recruiting

  • GSK Investigational Site

    Richmond, Virginia 23229
    United States

    Active - Recruiting

  • GSK Investigational Site

    Appleton, Wisconsin 54911
    United States

    Active - Recruiting

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