Recruiting NCT05855200

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

Phase III Interventional Colonic Neoplasms Neoplasms, Colon

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied: The protocol lists: Dostarlimab, CAPEOX, FOLFOX.
Who it may be relevant to: Registry conditions: Colonic Neoplasms, Neoplasms, Colon. Basic parameters: from 18 years · All.
What needs checking: Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place: United States, Argentina, Australia, Belgium, Brazil +23
Next step: Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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.

Interventions

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

Primary outcome measures

Event-free Survival (EFS) Assessed by Blinded Independent Central Review (BICR) [Time frame: Up to approximately 5 years]

Secondary outcome measures (9)

Overall Survival (OS) [Time frame: Up to approximately 5 years]
Number of Participants with Pathological Response [Time frame: Up to approximately 5 years]
Event-free Survival (EFS) assessed by local assessment [Time frame: Up to approximately 5 years]
Number of Participants with treatment emergent adverse events (AEs), serious adverse events (SAEs), Immune-mediated Adverse Event (imAEs), AEs leading to death and AEs leading to discontinuation of study treatment [Time frame: Up to approximately 5 years]
Number of Participants with AEs and SAEs by Severity [Time frame: Up to approximately 5 years]
Serum Concentration of Dostarlimab [Time frame: Predose and End of Infusion (EoI) of Cycle 1 and EoI of Cycle 2 to Cycle 10 (each cycle is of 21 days)]
Serum Concentration of Dostarlimab at End of Infusion (C-EoI) [Time frame: End of Infusion (EoI) of Cycle 1 to Cycle 10 (each cycle is of 21 days)]
Serum Predose trough concentration (Ctrough) of Dostarlimab [Time frame: Predose of Cycle 1 to Cycle 10 (each cycle is of 21 days)]
Number of Participants with Anti-Drug Antibodies against Dostarlimab [Time frame: Up to approximately 5 years]

Eligibility 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

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation: Randomized
Model: Parallel assignment
Masking: Open label
Primary purpose: Treatment