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Study of Perioperative Dostar...

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

Last Updated: 2026-01-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE3

Total Enrollment

892 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-08-01

Study Completion Date

2031-03-27

Brief Summary

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The primary purpose of this study is to evaluate the efficacy of perioperative dostarlimab compared with standard of care (SOC) in participants with untreated T4N0 or Stage III (resectable), defective mismatch repair/ microsatellite instability high (dMMR/MSI-H) colon cancer.

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Detailed Description

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Conditions

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Colonic Neoplasms Neoplasms, Colon

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

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Study Groups

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Dostarlimab

Participants will receive Dostarlimab pre and post surgery

Group Type EXPERIMENTAL

Dostarlimab

Intervention Type BIOLOGICAL

Dostarlimab will be administered.

Standard of Care (SOC)

Participants will receive SOC (FOLFOX/CAPEOX) or undergo expectant observation post surgery.

Group Type ACTIVE_COMPARATOR

CAPEOX

Intervention Type DRUG

CAPEOX will be administered.

FOLFOX

Intervention Type DRUG

FOLFOX will be administered.

Interventions

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Dostarlimab

Dostarlimab will be administered.

Intervention Type BIOLOGICAL

CAPEOX

CAPEOX will be administered.

Intervention Type DRUG

FOLFOX

FOLFOX will be administered.

Intervention Type DRUG

Eligibility Criteria

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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

* 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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

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US GSK Clinical Trials Call Center

Role: CONTACT

[email protected]

877-379-3718

EU GSK Clinical Trials Call Center

Role: CONTACT

[email protected]

Explore related publications, articles, or registry entries linked to this study.

Starling N, Elez E, Strickler JH, Benson A, Oki E, Mendez G, Ferreiro R, Lau YL, Kawazoe A, Tian M, Campbell N, Cohen DN, Edwards K, Stjepanovic N, Seligmann JF. A Phase III study of perioperative dostarlimab in patients with dMMR/MSI-H resectable colon cancer: AZUR-2 study design. Future Oncol. 2026 Jan 6:1-9. doi: 10.1080/14796694.2025.2606910. Online ahead of print.

Reference Type DERIVED

PMID: 41492912 (View on PubMed)

Other Identifiers

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2023-503265-27-00

Identifier Type: CTIS

Identifier Source: secondary_id

219606

Identifier Type: -

Identifier Source: org_study_id

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Study Results

Basic Information

Brief Summary

Related Clinical Trials

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Detailed Description

Conditions

Study Design

Study Groups

Dostarlimab

Dostarlimab

Standard of Care (SOC)

CAPEOX

FOLFOX

Interventions

Dostarlimab

CAPEOX

FOLFOX

Eligibility Criteria

Inclusion Criteria

Exclusion Criteria

Sponsors

GlaxoSmithKline

Responsible Party

Principal Investigators

GSK Clinical Trials

Locations

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