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

JRCT ID: jRCT2011230016

Registered date:05/07/2023

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Colon Cancer
• Date of first enrollment: 04/12/2023
• Target sample size: 50
• Countries of recruitment: United Kingdom,Japan
• Study type: Interventional

Intervention(s)

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

Outcome(s)

• Primary Outcome: Event-free Survival (EFS) Assessed by Blinded Independent Central Review (BICR)

Secondary Outcome

-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

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include 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

Exclude 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

Related Information

• Primary Sponsor: Ishibashi Hideyasu