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Clinical Trials List

Protocol Number219606 (AZUR 2)

NCT Number(ClinicalTrials.gov Identfier)NCT05855200

Active

2023-08-01 - 2029-01-17

Phase III

Not yet recruiting1

Recruiting3

ICD-10C18.3

Malignant neoplasm of hepatic flexure

ICD-10Z51.12

Encounter for antineoplastic immunotherapy

ICD-9153.0

Malignant neoplasm of hepatic flexure colon

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

Trial Applicant

GlaxoSmithKline
Sponsor
Trial scale

Multi-Regional Multi-Center
Update

2026/02/01

Investigators and Locations

Principal Investigator Kun-Huei Yeh Division of Hematology & Oncology

National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Hung-Chih Hsu 無

Linkou Chang Gung Medical Foundation

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 陳鴻華無

Kaoshiung Chang Gung Memorial Hospital of the C.G.M.F.

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Not yet recruiting

Principal Investigator Yu-Min Yeh Division of General Internal Medicine

National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Condition/Disease

Untreated T4N0 or stage III mismatch repair-deficient (dMMR)/microsatellite instability-high (MSI-H) resectable colon cancer

Objectives

main target Evaluating the efficacy of dostarlimab compared with SOC before and after surgery in subjects with untreated T4N0 or stage III (resectable) dMMR/MSI-H colon cancer secondary goals Evaluating the efficacy of preoperative adjuvant dostarlimab in subjects with untreated T4N0 or stage III (resectable) dMMR/MSI-H colon cancer Estimated overall survival (OS) of dostarlimab before and after surgery versus SOC in subjects with untreated T4N0 or stage III (resectable) dMMR/MSI-H colon cancer differences in aspects Evaluating the efficacy of dostarlimab compared with SOC before and after surgery in subjects with untreated T4N0 or stage III (resectable) dMMR/MSI-H colon cancer To evaluate the safety and tolerability of dostarlimab compared with SOC in subjects with untreated T4N0 or stage III (resectable) dMMR/MSI-H colon cancer To describe the pharmacokinetics (PK) of dostarlimab in subjects with untreated T4N0 or stage III (resectable) dMMR/MSI-H colon cancer Determining the immunogenicity of dostarlimab in subjects with untreated T4N0 or stage III (resectable) dMMR/MSI-H colon cancer

Test Drug

JEMPERLI 500 mg concentrate for solution for infusion

Active Ingredient

Dostarlimab
Dostarlimab

Dosage Form

Concentrate For Solution For Infusion

Dosage

50mg/1ml
50mg/1ml

Endpoints

Event-free survival (EFS) for recurrence as assessed by blinded independent central review (BICR)
The event is defined as:
o Disease recurrence, radiological assessment based on BICR
o Progressive disease inoperable (local assessment)
o Disease recurrence, new lesions detected based on post-operative pathological evaluation (local assessment)
o Death from any cause
o Treatment-related toxicities that render the subject unfit for surgery

Inclution Criteria

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

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

The Estimated Number of Participants

Taiwan

12 participants
Global

711 participants