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
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Trial Applicant
GlaxoSmithKline
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Sponsor
-
Trial scale
Multi-Regional Multi-Center
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Update
2026/06/23
Investigators and Locations
Co-Principal Investigator
- Been Ren Lin 無
- Chih-Hung Hsu 無
- TSUNG-HAO LIU 無
- YU-YUN SHAO 無
- 陳姿君 無
- 林宗哲 無
- 梁逸歆 無
- 鄭永銘 無
- 洪基翔 無
- 陳國興 無
The Actual Total Number of Participants Enrolled
0 Recruiting
The Actual Total Number of Participants Enrolled
0 Recruiting
The Actual Total Number of Participants Enrolled
0 Not yet recruiting
Principal Investigator
Yu-Min Yeh
Co-Principal Investigator
The Actual Total Number of Participants Enrolled
0 Recruiting
Condition/Disease
Colonic Neoplasms
Objectives
Primary Objective:
Evaluate the efficacy of dostarlimab versus SOC before and after surgery in patients with treatment-naïve T4N0 or stage III (resectable) dMMR/MSI-H colorectal cancer.
Secondary Objectives:
Evaluate the efficacy of preoperative adjuvant dostarlimab in patients with treatment-naïve T4N0 or stage III (resectable) dMMR/MSI-H colorectal cancer.
Estimate the difference in overall survival (OS) between patients receiving dostarlimab before and after surgery and those receiving SOC in patients with treatment-naïve T4N0 or stage III (resectable) dMMR/MSI-H colorectal cancer.
Evaluate the efficacy of dostarlimab versus SOC before and after surgery in patients with treatment-naïve T4N0 or stage III (resectable) dMMR/MSI-H colorectal cancer.
Secondary Objectives:
Evaluate the efficacy of dostarlimab versus SOC before and after surgery in patients with treatment-naïve T4N0 or stage III (resectable) colorectal cancer. Evaluation of the safety and tolerability of dostarlimab compared to SOC in subjects with dMMR/MSI-H colorectal cancer.
Description of the pharmacokinetics (PK) of dostarlimab in subjects with treatment-naïve T4N0 or stage III (resectable) dMMR/MSI-H colorectal cancer.
Assessment of the immunogenicity of dostarlimab in subjects with treatment-naïve T4N0 or stage III (resectable) dMMR/MSI-H colorectal cancer.
Test Drug
Injection
Active Ingredient
Dostarlimab
Dostarlimab
Dostarlimab
Dosage Form
Concentrate For Solution For Infusion
Dosage
50mg/1ml
50mg/1ml
50mg/1ml
Endpoints
• Event-free survival (EFS) of relapse assessed by blinded independent central review (BICR)
An event is defined as:
o Disease relapse based on radiological assessment by BICR
o Disease progression rendering the patient inoperable (local assessment)
o Disease relapse based on postoperative pathological assessment revealing a new lesion (local assessment)
o Death from any cause
o Treatment-related toxicities that render the subject unsuitable for surgery
An event is defined as:
o Disease relapse based on radiological assessment by BICR
o Disease progression rendering the patient inoperable (local assessment)
o Disease relapse based on postoperative pathological assessment revealing a new lesion (local assessment)
o Death from any cause
o Treatment-related toxicities that render the subject unsuitable 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
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 the current diagnosis of colon cancer
Has a tumor that, in the investigator's judgment is causing symptomatic bowel obstruction or otherwise requires urgent/emergent surgery at the time of screening. Participants with a history of colonic obstruction are eligible after obstruction is relieved by a diverting stoma (defunctioning ileostomy or colostomy). Patients with a history of colonic obstruction in the context of current colon cancer diagnosis and treated with colonic stents are not eligible.
Has undergone any major surgical procedure, open biopsy, or experienced significant traumatic injury within 28 days prior to randomization
Has any history of interstitial lung disease or pneumonitis and/or history of radiation induced enteritis.
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
Has distant metastatic disease.
Has received prior medical therapy (chemotherapy, immunotherapy, biologic, or targeted therapy), radiation therapy or surgery for management of the current diagnosis of colon cancer
Has a tumor that, in the investigator's judgment is causing symptomatic bowel obstruction or otherwise requires urgent/emergent surgery at the time of screening. Participants with a history of colonic obstruction are eligible after obstruction is relieved by a diverting stoma (defunctioning ileostomy or colostomy). Patients with a history of colonic obstruction in the context of current colon cancer diagnosis and treated with colonic stents are not eligible.
Has undergone any major surgical procedure, open biopsy, or experienced significant traumatic injury within 28 days prior to randomization
Has any history of interstitial lung disease or pneumonitis and/or history of radiation induced enteritis.
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
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Taiwan
12 participants
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Global
711 participants
