臨床研究等提出・公開システム

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 (AZUR-2
)

Study of Perioperative Dostarlimab in Participants With Untreated T4N0 or Stage III dMMR/MSI-H Resectable Colon Cancer (AZUR-2) (AZUR-2)

Ishibashi Hideyasu

GlaxoSmithKline K.K.

Akasaka Intercity AIR, 1-8-1 Akasaka, Minato-ku, Tokyo, Japan

jp.gskjrct@gsk.com

Ishibashi Hideyasu

GlaxoSmithKline K.K.

Akasaka Intercity AIR, 1-8-1 Akasaka, Minato-ku, Tokyo, Japan

+81-120-561-007

jp.gskjrct@gsk.com

Recruiting

July. 18, 2023

Interventional

randomized controlled trial

open(masking not used)

active control

parallel assignment

treatment purpose

-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

-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

Both

Colon Cancer

Biological: Dostarlimab
Dostarlimab will be administered.
Drug: CAPEOX
CAPEOX will be administered.
Drug: FOLFOX
FOLFOX will be administered.

Event-free Survival (EFS) Assessed by Blinded Independent Central Review (BICR)

-Number of Participants with Pathological Response
-Overall Survival (OS)
-Event-free Survival (EFS) assessed by local assessment
-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
-Number of Participants with AEs and SAEs by Severity.
-Serum Concentration of Dostarlimab
-Serum Concentration of Dostarlimab at End of Infusion (C-EoI)
-Serum Predose trough concentration (Ctrough) of Dostarlimab
-Number of Participants with Anti-Drug Antibodies against Dostarlimab

+81-11-716-1161

June. 20, 2023

No

United Kingdom/United States/Argentina/Australia/Belgium/Brazil/Canada/China/Estonia/Finland/France/Germany/Greece/Italy/Korea, Republic of/Mexico/Netherlands/Norway/Panama/Portugal/Spain/Sweden/Taiwan/Turkey