Colonic Neoplasms Clinical Trial
— AZUR-2Official 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
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.
| Status | Recruiting |
| Enrollment | 711 |
| Est. completion date | December 25, 2030 |
| Est. primary completion date | December 15, 2028 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | 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 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 enrollment - 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 |
| Country | Name | City | State |
|---|---|---|---|
| Argentina | GSK Investigational Site | Buenos Aires | |
| Argentina | GSK Investigational Site | Buenos Aires | |
| Argentina | GSK Investigational Site | Capital Federal | Buenos Aires |
| Argentina | GSK Investigational Site | Ciudad de Buenos Aires | Buenos Aires |
| Argentina | GSK Investigational Site | Cordoba | |
| Argentina | GSK Investigational Site | Mar del Plata | Buenos Aires |
| Argentina | GSK Investigational Site | Rosario | Santa Fe |
| Argentina | GSK Investigational Site | Santa Fe | |
| Australia | GSK Investigational Site | Heidelberg | Victoria |
| Australia | GSK Investigational Site | Melbourne | |
| Australia | GSK Investigational Site | St Leonards | New South Wales |
| Australia | GSK Investigational Site | Waratah | New South Wales |
| Australia | GSK Investigational Site | Woolloongabba | Queensland |
| Belgium | GSK Investigational Site | Aalst | |
| Belgium | GSK Investigational Site | Anderlecht | |
| Belgium | GSK Investigational Site | Bruxelles | |
| Belgium | GSK Investigational Site | Edegem | |
| Belgium | GSK Investigational Site | Gent | |
| Belgium | GSK Investigational Site | Leuven | |
| Belgium | GSK Investigational Site | Liège | |
| Belgium | GSK Investigational Site | Roeselare | |
| Brazil | GSK Investigational Site | Barretos | São Paulo |
| Brazil | GSK Investigational Site | Lages | Santa Catarina |
| Brazil | GSK Investigational Site | Natal | Rio Grande Do Norte |
| Brazil | GSK Investigational Site | Porto Alegre | Rio Grande Do Sul |
| Brazil | GSK Investigational Site | Salvador | Bahia |
| Brazil | GSK Investigational Site | Sao Jose do Rio Preto | São Paulo |
| Brazil | GSK Investigational Site | São Paulo | |
| Brazil | GSK Investigational Site | São Paulo | |
| Brazil | GSK Investigational Site | Teresina | Piauí |
| Brazil | GSK Investigational Site | Vitória | Espírito Santo |
| Canada | GSK Investigational Site | Edmonton | Alberta |
| Canada | GSK Investigational Site | Halifax | |
| Canada | GSK Investigational Site | Montreal | Quebec |
| Canada | GSK Investigational Site | Ottawa | Ontario |
| Canada | GSK Investigational Site | Toronto | Ontario |
| Estonia | GSK Investigational Site | Tallinn | |
| Estonia | GSK Investigational Site | Tallinn | |
| Estonia | GSK Investigational Site | Tartu | |
| Finland | GSK Investigational Site | Helsinki | |
| Finland | GSK Investigational Site | Tampere | |
| Finland | GSK Investigational Site | Turku | |
| France | GSK Investigational Site | Lyon | |
| France | GSK Investigational Site | Marseille Cedex 5 | |
| France | GSK Investigational Site | Nantes | |
| France | GSK Investigational Site | Nice Cedex 2 | |
| France | GSK Investigational Site | Paris | |
| France | GSK Investigational Site | Pessac cedex | |
| France | GSK Investigational Site | Rennes Cedex | |
| France | GSK Investigational Site | Rouen | |
| France | GSK Investigational Site | Saint-Priest en Jarez | |
| France | GSK Investigational Site | Suresnes | |
| France | GSK Investigational Site | Toulouse Cedex 9 | |
| France | GSK Investigational Site | Villejuif Cedex | |
| Germany | GSK Investigational Site | Berlin | |
| Germany | GSK Investigational Site | Duesseldorf | Nordrhein-Westfalen |
| Germany | GSK Investigational Site | Frankfurt | Hessen |
| Germany | GSK Investigational Site | Halle | Sachsen-Anhalt |
| Germany | GSK Investigational Site | Leipzig | Sachsen |
| Germany | GSK Investigational Site | Luebeck | Schleswig-Holstein |
| Germany | GSK Investigational Site | Mannheim | Baden-Wuerttemberg |
| Germany | GSK Investigational Site | Marburg | Hessen |
| Germany | GSK Investigational Site | Muenchen | Bayern |
| Greece | GSK Investigational Site | Athens | |
| Greece | GSK Investigational Site | Thessaloniki | |
| Greece | GSK Investigational Site | Thessaloniki | |
| Hungary | GSK Investigational Site | Debrecen | |
| Italy | GSK Investigational Site | Genova | Liguria |
| Italy | GSK Investigational Site | Milano | Lombardia |
| Italy | GSK Investigational Site | Monserrato | Sardegna |
| Italy | GSK Investigational Site | Napoli | Campania |
| Italy | GSK Investigational Site | Padova | Veneto |
| Italy | GSK Investigational Site | Pisa | Toscana |
| Italy | GSK Investigational Site | Reggio Emilia | Emilia Romagna |
| Italy | GSK Investigational Site | Roma | Lazio |
| Italy | GSK Investigational Site | Roma | Lazio |
| Italy | GSK Investigational Site | Rozzano (MI) | Lombardia |
| Japan | GSK Investigational Site | Aichi | |
| Japan | GSK Investigational Site | Chiba | |
| Japan | GSK Investigational Site | Fukuoka | |
| Japan | GSK Investigational Site | Hokkaido | |
| Japan | GSK Investigational Site | Hyogo | |
| Japan | GSK Investigational Site | Ibaraki | |
| Japan | GSK Investigational Site | Kanagawa | |
| Japan | GSK Investigational Site | Kanagawa | |
| Japan | GSK Investigational Site | Kyoto | |
| Japan | GSK Investigational Site | Okayama | |
| Japan | GSK Investigational Site | Osaka | |
| Japan | GSK Investigational Site | Osaka | |
| Japan | GSK Investigational Site | Osaka | |
| Japan | GSK Investigational Site | Osaka | |
| Japan | GSK Investigational Site | Shizuoka | |
| Japan | GSK Investigational Site | Tokyo | |
| Korea, Republic of | GSK Investigational Site | Daegu | |
| Korea, Republic of | GSK Investigational Site | Seoul | |
| Korea, Republic of | GSK Investigational Site | Seoul | |
| Korea, Republic of | GSK Investigational Site | Seoul | |
| Korea, Republic of | GSK Investigational Site | Seoul | |
| Korea, Republic of | GSK Investigational Site | Sungnam | |
| Mexico | GSK Investigational Site | Ciudad de México | Estado De México |
| Mexico | GSK Investigational Site | Guadalajara | Jalisco |
| Mexico | GSK Investigational Site | Guadalajara | Jalisco |
| Mexico | GSK Investigational Site | Mexico | |
| Mexico | GSK Investigational Site | Oaxaca de Juarez | Oaxaca |
| Mexico | GSK Investigational Site | San Pedro Garza Garcia | Nuevo Leon |
| Mexico | GSK Investigational Site | Tijuana | Baja California |
| Netherlands | GSK Investigational Site | Breda | |
| Netherlands | GSK Investigational Site | Maastricht | |
| Netherlands | GSK Investigational Site | Nijmegen | |
| Netherlands | GSK Investigational Site | Utrecht | |
| Norway | GSK Investigational Site | Bergen | |
| Norway | GSK Investigational Site | Drammen | |
| Norway | GSK Investigational Site | Lørenskog | |
| Norway | GSK Investigational Site | Oslo | |
| Norway | GSK Investigational Site | Stavanger | |
| Norway | GSK Investigational Site | Tromsø | |
| Panama | GSK Investigational Site | Panama | |
| Portugal | GSK Investigational Site | Almada | |
| Portugal | GSK Investigational Site | Coimbra | |
| Portugal | GSK Investigational Site | Lisboa | |
| Spain | GSK Investigational Site | Baracaldo/Vizcaya | |
| Spain | GSK Investigational Site | Barcelona | |
| Spain | GSK Investigational Site | Barcelona | |
| Spain | GSK Investigational Site | Barcelona | |
| Spain | GSK Investigational Site | Barcelona | |
| Spain | GSK Investigational Site | Córdoba | |
| Spain | GSK Investigational Site | Elche | |
| Spain | GSK Investigational Site | Granada | |
| Spain | GSK Investigational Site | Jaén | |
| Spain | GSK Investigational Site | Las Palmas De Gran Canaria | |
| Spain | GSK Investigational Site | Madrid | |
| Spain | GSK Investigational Site | Madrid | |
| Spain | GSK Investigational Site | Madrid | |
| Spain | GSK Investigational Site | Madrid | |
| Spain | GSK Investigational Site | Madrid | |
| Spain | GSK Investigational Site | Majadahonda | Madrid |
| Spain | GSK Investigational Site | Málaga | |
| Spain | GSK Investigational Site | Oviedo | Asturias |
| Spain | GSK Investigational Site | Pamplona | |
| Spain | GSK Investigational Site | San Sebastian | |
| Spain | GSK Investigational Site | Santander | |
| Spain | GSK Investigational Site | Sevilla | |
| Spain | GSK Investigational Site | Valencia | |
| Spain | GSK Investigational Site | Valencia | |
| Spain | GSK Investigational Site | Zaragoza | |
| Sweden | GSK Investigational Site | Eskilstuna | |
| Sweden | GSK Investigational Site | Götebrog | |
| Sweden | GSK Investigational Site | Linköping | |
| Sweden | GSK Investigational Site | Malmö | |
| Sweden | GSK Investigational Site | Stockholm | |
| Sweden | GSK Investigational Site | Stockholm | |
| Sweden | GSK Investigational Site | Uppsala | |
| Taiwan | GSK Investigational Site | Kaohsiung | |
| Taiwan | GSK Investigational Site | Tainan | |
| Taiwan | GSK Investigational Site | Taipei | |
| Taiwan | GSK Investigational Site | Taoyuan City | |
| Turkey | GSK Investigational Site | Ankara | |
| Turkey | GSK Investigational Site | Ankara | |
| Turkey | GSK Investigational Site | Istanbul | |
| United Kingdom | GSK Investigational Site | Birmingham | |
| United Kingdom | GSK Investigational Site | Chelmsford | Essex |
| United Kingdom | GSK Investigational Site | Cheltenham | Gloucestershire |
| United Kingdom | GSK Investigational Site | Cottingham | |
| United Kingdom | GSK Investigational Site | Edinburgh | |
| United Kingdom | GSK Investigational Site | Leeds | |
| United Kingdom | GSK Investigational Site | London | |
| United Kingdom | GSK Investigational Site | London | |
| United Kingdom | GSK Investigational Site | Manchester | Greater Manchester |
| United Kingdom | GSK Investigational Site | Sutton | |
| United States | GSK Investigational Site | Aberdeen | South Dakota |
| United States | GSK Investigational Site | Akron | Ohio |
| United States | GSK Investigational Site | Ann Arbor | Michigan |
| United States | GSK Investigational Site | Baton Rouge | Louisiana |
| United States | GSK Investigational Site | Bethesda | Maryland |
| United States | GSK Investigational Site | Bronx | New York |
| United States | GSK Investigational Site | Bronx | New York |
| United States | GSK Investigational Site | Chicago | Illinois |
| United States | GSK Investigational Site | Chicago | Illinois |
| United States | GSK Investigational Site | Chicago | Illinois |
| United States | GSK Investigational Site | Cincinnati | Ohio |
| United States | GSK Investigational Site | Cleveland | Ohio |
| United States | GSK Investigational Site | Dallas | Texas |
| United States | GSK Investigational Site | Detroit | Michigan |
| United States | GSK Investigational Site | Durham | North Carolina |
| United States | GSK Investigational Site | Elmhurst | Illinois |
| United States | GSK Investigational Site | Fort Lauderdale | Florida |
| United States | GSK Investigational Site | Greenville | North Carolina |
| United States | GSK Investigational Site | Greenville | South Carolina |
| United States | GSK Investigational Site | Lebanon | New Hampshire |
| United States | GSK Investigational Site | Lexington | Kentucky |
| United States | GSK Investigational Site | Los Angeles | California |
| United States | GSK Investigational Site | Louisville | Kentucky |
| United States | GSK Investigational Site | Marietta | Georgia |
| United States | GSK Investigational Site | Minneapolis | Minnesota |
| United States | GSK Investigational Site | Naperville | Illinois |
| United States | GSK Investigational Site | Nashville | Tennessee |
| United States | GSK Investigational Site | New Haven | Connecticut |
| United States | GSK Investigational Site | New Hyde Park | New York |
| United States | GSK Investigational Site | New York | New York |
| United States | GSK Investigational Site | New York | New York |
| United States | GSK Investigational Site | Oklahoma City | Oklahoma |
| United States | GSK Investigational Site | Omaha | Nebraska |
| United States | GSK Investigational Site | Omaha | Nebraska |
| United States | GSK Investigational Site | Pierre | South Dakota |
| United States | GSK Investigational Site | Pittsburgh | Pennsylvania |
| United States | GSK Investigational Site | Richmond | Virginia |
| United States | GSK Investigational Site | Shirley | New York |
| United States | GSK Investigational Site | Sioux Falls | South Dakota |
| United States | GSK Investigational Site | Tucson | Arizona |
| United States | GSK Investigational Site | Washington | District of Columbia |
| United States | GSK Investigational Site | Westwood | Kansas |
| United States | GSK Investigational Site | Wynnewood | Pennsylvania |
| United States | GSK Investigational Site | Yankton | South Dakota |
| Lead Sponsor | Collaborator |
|---|---|
| GlaxoSmithKline |
United States, Argentina, Australia, Belgium, Brazil, Canada, Estonia, Finland, France, Germany, Greece, Hungary, Italy, Japan, Korea, Republic of, Mexico, Netherlands, Norway, Panama, Portugal, Spain, Sweden, Taiwan, Turkey, United Kingdom,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Event-free Survival (EFS) Assessed by Blinded Independent Central Review (BICR) | 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 | Up to approximately 5 years | |
| Secondary | Number of Participants with Pathological Response | Pathological response will be categorized as a complete pathologic response, major pathologic response, partial pathologic response, or negligible pathologic response. | Up to approximately 5 years | |
| Secondary | Overall Survival (OS) | OS is defined as time from randomization to death from any cause | Up to approximately 5 years | |
| Secondary | Event-free Survival (EFS) assessed by local assessment | 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 | Up to approximately 5 years | |
| Secondary | Number of Participants with treatment emergent adverse events (AEs), serious adverse events (SAEs), Immune-related Adverse Event (irAEs), AEs leading to death and AEs leading to discontinuation of study treatment | Up to approximately 5 years | ||
| Secondary | Number of Participants with AEs and SAEs by Severity | Up to approximately 5 years | ||
| Secondary | Serum Concentration of Dostarlimab | Predose and End of Infusion (EoI) of Cycle 1 and EoI of Cycle 2 to Cycle 10 (each cycle is of 21 days) | ||
| Secondary | Serum Concentration of Dostarlimab at End of Infusion (C-EoI) | End of Infusion (EoI) of Cycle 1 to Cycle 10 (each cycle is of 21 days) | ||
| Secondary | Serum Predose trough concentration (Ctrough) of Dostarlimab | Predose of Cycle 1 to Cycle 10 (each cycle is of 21 days) | ||
| Secondary | Number of Participants with Anti-Drug Antibodies against Dostarlimab | Up to approximately 5 years |
| Status | Clinical Trial | Phase | |
|---|---|---|---|
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