Back to Trials
NCT05855200PHASE3Recruiting

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

GlaxoSmithKline

Start Date

8/1/2023

Completion Date

3/27/2031

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

Age Range: 18 years to No maximum

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 Criteria: * Has distant metastatic disease. * Has received prior medical therapy (chemotherapy, immunotherapy, biologic, or targeted therapy), radiation therapy or surgery for management of the current diagnosis of colon cancer * Has a tumor that, in the investigator's judgment is causing symptomatic bowel obstruction or otherwise requires urgent/emergent surgery at the time of screening. Participants with a history of colonic obstruction are eligible after obstruction is relieved by a diverting stoma (defunctioning ileostomy or colostomy). Patients with a history of colonic obstruction in the context of current colon cancer diagnosis and treated with colonic stents are not eligible. * 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 and/or history of radiation induced enteritis. * 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

Interventions

BIOLOGICAL

Dostarlimab

DRUG

CAPEOX

DRUG

FOLFOX

Interested in This Trial?

Contact the trial locations directly using the information below to learn more about enrollment.

Expressing interest lets you review the study and consent before we connect you with the research site.

Conditions

Colonic NeoplasmsNeoplasms, Colon

Locations

GSK Investigational Site

Tucson, Arizona 85715

United States

GSK Investigational Site

Los Angeles, California 90027

United States

GSK Investigational Site

New Haven, Connecticut 06520

United States

GSK Investigational Site

Washington D.C., District of Columbia 20010

United States

GSK Investigational Site

Deerfield Beach, Florida 33064

United States

GSK Investigational Site

Fort Lauderdale, Florida 33316

United States

GSK Investigational Site

Marietta, Georgia 30060

United States

GSK Investigational Site

Chicago, Illinois 60611

United States

GSK Investigational Site

Chicago, Illinois 60612

United States

GSK Investigational Site

Chicago, Illinois 60637

United States

GSK Investigational Site

Naperville, Illinois 60126

United States

GSK Investigational Site

Naperville, Illinois 60540

United States

GSK Investigational Site

Westwood, Kansas 66205

United States

GSK Investigational Site

Lexington, Kentucky 40503

United States

GSK Investigational Site

Louisville, Kentucky 40206

United States

GSK Investigational Site

Baton Rouge, Louisiana 70809

United States

GSK Investigational Site

Bethesda, Maryland 20817

United States

GSK Investigational Site

Ann Arbor, Michigan 48109

United States

GSK Investigational Site

Detroit, Michigan 48202

United States

GSK Investigational Site

Minneapolis, Minnesota 55455

United States

GSK Investigational Site

Joplin, Missouri 64804

United States

GSK Investigational Site

St Louis, Missouri 63128

United States

GSK Investigational Site

St Louis, Missouri 63141

United States

GSK Investigational Site

Grand Island, Nebraska 68803

United States

GSK Investigational Site

Omaha, Nebraska 68130

United States

GSK Investigational Site

Omaha, Nebraska 68198

United States

GSK Investigational Site

Lebanon, New Hampshire 03756

United States

GSK Investigational Site

New York, New York 10028

United States

GSK Investigational Site

New York, New York 10469

United States

GSK Investigational Site

New York, New York 11042

United States

GSK Investigational Site

New York, New York 11967

United States

GSK Investigational Site

The Bronx, New York 10461

United States

GSK Investigational Site

Durham, North Carolina 27710

United States

GSK Investigational Site

Akron, Ohio 44304

United States

GSK Investigational Site

Cincinnati, Ohio 45220

United States

GSK Investigational Site

Cleveland, Ohio 44111

United States

GSK Investigational Site

Cleveland, Ohio 44142

United States

GSK Investigational Site

Cleveland, Ohio 44196

United States

GSK Investigational Site

Oklahoma City, Oklahoma 73104

United States

GSK Investigational Site

Oklahoma City, Oklahoma 73120

United States

GSK Investigational Site

Pittsburgh, Pennsylvania 15212

United States

GSK Investigational Site

Sioux Falls, South Dakota 57078

United States

GSK Investigational Site

Sioux Falls, South Dakota 57105

United States

GSK Investigational Site

Sioux Falls, South Dakota 57401

United States

GSK Investigational Site

Sioux Falls, South Dakota 57501

United States

GSK Investigational Site

Dallas, Texas 75235

United States

GSK Investigational Site

Dallas, Texas 75390

United States

GSK Investigational Site

Richmond, Virginia 23229

United States

GSK Investigational Site

Appleton, Wisconsin 54911

United States

GSK Investigational Site

Buenos Aires, 1093

Argentina

GSK Investigational Site

Buenos Aires, C1180AAX

Argentina

GSK Investigational Site

Buenos Aires, C1181ACH

Argentina

GSK Investigational Site

Capital Federal, C1426ANZ

Argentina

GSK Investigational Site

Ciudad Autonoma de Buenos Aire, C1431FWO

Argentina

GSK Investigational Site

Córdoba, 5000

Argentina

GSK Investigational Site

Mar del Plata, 7600

Argentina

GSK Investigational Site

Rosario, S2002

Argentina

GSK Investigational Site

San Miguel de Tucumán, T4000IHE

Argentina

GSK Investigational Site

Santa Fe, S3000FUJ

Argentina

GSK Investigational Site

Newcastle, New South Wales 2298

Australia

GSK Investigational Site

St Leonards, New South Wales 2065

Australia

GSK Investigational Site

Woolangabba, Queensland 4102

Australia

GSK Investigational Site

Heidelberg, Victoria 3084

Australia

GSK Investigational Site

Melbourne, Victoria 3004

Australia

GSK Investigational Site

Aalst, 9300

Belgium

GSK Investigational Site

Brussels, 1070

Belgium

GSK Investigational Site

Brussels, 1200

Belgium

GSK Investigational Site

Edegem, 2650

Belgium

GSK Investigational Site

Ghent, 9000

Belgium

GSK Investigational Site

Leuven, 3000

Belgium

GSK Investigational Site

Liège, 4000

Belgium

GSK Investigational Site

Roeselare, 8800

Belgium

GSK Investigational Site

Barretos, 14784-400

Brazil

GSK Investigational Site

Belém, 66.073-005

Brazil

GSK Investigational Site

Campo Grande, 79002-061

Brazil

GSK Investigational Site

Lages, 88501-001

Brazil

GSK Investigational Site

Natal, 59075-740

Brazil

GSK Investigational Site

Porto Alegre, 90610-000

Brazil

GSK Investigational Site

Salvador, 40414-120

Brazil

GSK Investigational Site

São José do Rio Preto, 15090-000

Brazil

GSK Investigational Site

São Paulo, 01509-010

Brazil

GSK Investigational Site

São Paulo, 04312903

Brazil

GSK Investigational Site

Teresina, 64049-200

Brazil

GSK Investigational Site

Vitória, 29043-260

Brazil

GSK Investigational Site

Edmonton, Alberta T6G 1Z2

Canada

GSK Investigational Site

Halifax, Nova Scotia B3H 1V7

Canada

GSK Investigational Site

Ottawa, Ontario K1H 8L6

Canada

GSK Investigational Site

Toronto, Ontario M5G 2M9

Canada

GSK Investigational Site

Montreal, Quebec H4A 3J1

Canada

GSK Investigational Site

Beijing, 100036

China

GSK Investigational Site

Beijing, 100083

China

GSK Investigational Site

Beijing, 100730

China

GSK Investigational Site

Changchun, 130021

China

GSK Investigational Site

Changsha, 410013

China

GSK Investigational Site

Chengdu, 610041

China

GSK Investigational Site

Chongqing, 400042

China

GSK Investigational Site

Chongqing, 400042

China

GSK Investigational Site

Guangzhou, 510060

China

GSK Investigational Site

Guangzhou, 510655

China

GSK Investigational Site

Hangzhou, 310016

China

GSK Investigational Site

Hangzhou, 310022

China

GSK Investigational Site

Hangzhou, 311100

China

GSK Investigational Site

Hangzhou,

China

GSK Investigational Site

Harbin, 150000

China

GSK Investigational Site

Jinan, 250117

China

GSK Investigational Site

Kunming, 650106

China

GSK Investigational Site

Meizhou, 514700

China

GSK Investigational Site

Nanchang, 330006

China

GSK Investigational Site

Nanchang, 330029

China

GSK Investigational Site

Shanghai, 200032

China

GSK Investigational Site

Shanghai, 200032

China

GSK Investigational Site

Shenzhen, 518036

China

GSK Investigational Site

Taiyuan, 030013

China

GSK Investigational Site

Tianjin, 300000

China

GSK Investigational Site

Wuhan, 430030

China

GSK Investigational Site

Xiamen, 361004

China

GSK Investigational Site

Yangzhou, 225001

China

GSK Investigational Site

Zhengzhou, 450052

China

GSK Investigational Site

Hradec Králové, 500 05

Czechia

GSK Investigational Site

Nový Jičín, 741 01

Czechia

GSK Investigational Site

Prague, 150 06

Czechia

GSK Investigational Site

Tallinn, 11312

Estonia

GSK Investigational Site

Tallinn, 13419

Estonia

GSK Investigational Site

Tartu, 50501

Estonia

GSK Investigational Site

Helsinki, 00029

Finland

GSK Investigational Site

Tampere, 33520

Finland

GSK Investigational Site

Turku, 20521

Finland

GSK Investigational Site

Lyon, 69008

France

GSK Investigational Site

Marseille, 13385

France

GSK Investigational Site

Nantes, 44093

France

GSK Investigational Site

Paris, 75015

France

GSK Investigational Site

Pessac, 33604

France

GSK Investigational Site

Rennes, 35042

France

GSK Investigational Site

Rouen, 76000

France

GSK Investigational Site

Saint-Priest-en-Jarez, 42270

France

GSK Investigational Site

Suresnes, 92150

France

GSK Investigational Site

Toulouse, 31059

France

GSK Investigational Site

Villejuif, 94805

France

GSK Investigational Site

Berlin, 13353

Germany

GSK Investigational Site

Düsseldorf, 40225

Germany

GSK Investigational Site

Frankfurt, 60488

Germany

GSK Investigational Site

Halle, 06120

Germany

GSK Investigational Site

Lübeck, 23562

Germany

GSK Investigational Site

Mannheim, 68167

Germany

GSK Investigational Site

München, 81377

Germany

GSK Investigational Site

München, 81737

Germany

GSK Investigational Site

Athens, 11528

Greece

GSK Investigational Site

Thessaloniki, 54639

Greece

GSK Investigational Site

Thessaloniki, 570 10

Greece

GSK Investigational Site

Bengaluru, Karnataka 560076

India

GSK Investigational Site

Ludhiana, Punjab 141123

India

GSK Investigational Site

Belagavi, 590010

India

GSK Investigational Site

Hyderabad, 500034

India

GSK Investigational Site

Nashik, 422002

India

GSK Investigational Site

Pune, 411040

India

GSK Investigational Site

Cagliari, 09042

Italy

GSK Investigational Site

Genova, 16132

Italy

GSK Investigational Site

Milan, 20162

Italy

GSK Investigational Site

Naples, 80131

Italy

GSK Investigational Site

Padova, 35128

Italy

GSK Investigational Site

Pisa, 56126

Italy

GSK Investigational Site

Reggio Emilia, 40123

Italy

GSK Investigational Site

Roma, 00152

Italy

GSK Investigational Site

Roma, 00168

Italy

GSK Investigational Site

Rozzano MI, 20089

Italy

GSK Investigational Site

Aichi, 464-8681

Japan

GSK Investigational Site

Chiba, 277-8577

Japan

GSK Investigational Site

Fukuoka, 812-8582

Japan

GSK Investigational Site

Hokkaido, 060-8648

Japan

GSK Investigational Site

Hyōgo, 650-0047

Japan

GSK Investigational Site

Ibaraki, 309-1793

Japan

GSK Investigational Site

Kanagawa, 216-8511

Japan

GSK Investigational Site

Kanagawa, 232-0024

Japan

GSK Investigational Site

Kyoto, 606-8507

Japan

GSK Investigational Site

Okayama, 710-8602

Japan

GSK Investigational Site

Osaka, 540-0006

Japan

GSK Investigational Site

Osaka, 541-8567

Japan

GSK Investigational Site

Osaka, 558-8558

Japan

GSK Investigational Site

Osaka, 565-0871

Japan

GSK Investigational Site

Osaka, 573-1191

Japan

GSK Investigational Site

Shizuoka, 411-8777

Japan

GSK Investigational Site

Tokyo, 104-0045

Japan

GSK Investigational Site

Tokyo, 135-8550

Japan

GSK Investigational Site

DF, 14000

Mexico

GSK Investigational Site

Guadalajara, 44280

Mexico

GSK Investigational Site

Guadalajara, 44650

Mexico

GSK Investigational Site

Mexico City, 03100

Mexico

GSK Investigational Site

Oaxaca City, 68020

Mexico

GSK Investigational Site

San Pedro Garza García, 66220

Mexico

GSK Investigational Site

Tijuana, 22010

Mexico

GSK Investigational Site

Breda, 4818 CK

Netherlands

GSK Investigational Site

Maastricht, 6229 HX

Netherlands

GSK Investigational Site

Nijmegen, 6525 GA

Netherlands

GSK Investigational Site

Utrecht, 3584 CX

Netherlands

GSK Investigational Site

Bergen, 5021

Norway

GSK Investigational Site

Kristiansand, 4604

Norway

GSK Investigational Site

Lrenskog, 1474

Norway

GSK Investigational Site

Oslo, 0407

Norway

GSK Investigational Site

Stavanger, 4011

Norway

GSK Investigational Site

Tromsø, 9019

Norway

GSK Investigational Site

Punta Pacifica Panama City Panama,

Panama

GSK Investigational Site

Bydgoszcz, 85-048

Poland

GSK Investigational Site

Warsaw, 02-034

Poland

GSK Investigational Site

Almada, 2805-267

Portugal

GSK Investigational Site

Coimbra, 3000-075

Portugal

GSK Investigational Site

Lisbon, 1649-035

Portugal

GSK Investigational Site

Daegu, 41404

South Korea

GSK Investigational Site

Gyeonggi-do, 463712

South Korea

GSK Investigational Site

Seoul, 06351

South Korea

GSK Investigational Site

Seoul, 06591

South Korea

GSK Investigational Site

Seoul, 138-736

South Korea

GSK Investigational Site

Badajoz, 06080

Spain

GSK Investigational Site

BaracaldoVizcaya, 48903

Spain

GSK Investigational Site

Barcelona, 08026

Spain

GSK Investigational Site

Barcelona, 08035

Spain

GSK Investigational Site

Barcelona, 08036

Spain

GSK Investigational Site

Córdoba, 14004

Spain

GSK Investigational Site

Donostia / San Sebastian, 20080

Spain

GSK Investigational Site

Elche Alicante, 03203

Spain

GSK Investigational Site

Granada, 18014

Spain

GSK Investigational Site

Jaén, 23007

Spain

GSK Investigational Site

L'Hospitalet de Llobrega, 08908

Spain

GSK Investigational Site

Las Palmas de Gran Canar, 35016

Spain

GSK Investigational Site

Madrid, 28006

Spain

GSK Investigational Site

Madrid, 28009

Spain

GSK Investigational Site

Madrid, 28034

Spain

GSK Investigational Site

Madrid, 28040

Spain

GSK Investigational Site

Madrid, 28040

Spain

GSK Investigational Site

Madrid, 28041

Spain

GSK Investigational Site

Madrid, 28046

Spain

GSK Investigational Site

Madrid, 28050

Spain

GSK Investigational Site

Madrid, 28222

Spain

GSK Investigational Site

Málaga, 29010

Spain

GSK Investigational Site

Oviedo, 33011

Spain

GSK Investigational Site

Pamplona, 31008

Spain

GSK Investigational Site

Santander, 39011

Spain

GSK Investigational Site

Seville, 41013

Spain

GSK Investigational Site

Valencia, 46009

Spain

GSK Investigational Site

Valencia, 46010

Spain

GSK Investigational Site

Valencia, 46014

Spain

GSK Investigational Site

Zaragoza, 50009

Spain

GSK Investigational Site

Eskilstuna, 63349

Sweden

GSK Investigational Site

Gothenburg, SE-413 45

Sweden

GSK Investigational Site

Linköping, SE-581 85

Sweden

GSK Investigational Site

Malmö, 20502

Sweden

GSK Investigational Site

Stockholm, 11219

Sweden

GSK Investigational Site

Stockholm, 11883

Sweden

GSK Investigational Site

Uppsala, SE-751 85

Sweden

GSK Investigational Site

Kaohsiung City, 833

Taiwan

GSK Investigational Site

Tainan, 704

Taiwan

GSK Investigational Site

Taipei, 100

Taiwan

GSK Investigational Site

Taoyuan, 333

Taiwan

GSK Investigational Site

Ankara, 06010

Turkey (Türkiye)

GSK Investigational Site

Ankara, 06230

Turkey (Türkiye)

GSK Investigational Site

Ankara,

Turkey (Türkiye)

GSK Investigational Site

Istanbul, 34722

Turkey (Türkiye)

GSK Investigational Site

Birmingham, B9 5SS

United Kingdom

GSK Investigational Site

Chelmsford, CM1 7ET

United Kingdom

GSK Investigational Site

Cheltenham, GL53 7AN

United Kingdom

GSK Investigational Site

Edinburgh, EH4 2XU

United Kingdom

GSK Investigational Site

Hull, HU16 5JQ

United Kingdom

GSK Investigational Site

Leeds West Yorkshire, LS9 7TF

United Kingdom

GSK Investigational Site

London, NW3 2QG

United Kingdom

GSK Investigational Site

London, SW3 6JJ

United Kingdom

GSK Investigational Site

Manchester, M20 4BX

United Kingdom

GSK Investigational Site

Sutton, SM2 5PT

United Kingdom