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

Authors
Category Primary study
Registry of TrialsJapan Primary Registry Network
Year 2023
INTERVENTION: Biological: Dostarlimab Dostarlimab will be administered. Drug: CAPEOX CAPEO Xwill be administered. Drug: FOLFOX FOLFO Xwill be administered. CONDITION: Colon Cancer 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 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
Epistemonikos ID: be4bb050141f322815bfa1e2ebc0051e8d08cd41
First added on: Aug 26, 2024