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

Phase 3

Recruiting

• Conditions: Colonic Neoplasms; Neoplasms, Colon

• Registration Number: NCT05855200
• Lead Sponsor: GlaxoSmithKline

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-5-3
• Last Update Posted: 2 September 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 711

Inclusion Criteria

Inclusion Criteria:<br><br> - Has untreated pathologically confirmed colon adenocarcinoma<br><br> - Has resectable colon adenocarcinoma defined as clinically T4N0 or Stage III<br><br> - Has radiologically evaluable disease<br><br> - Has a tumor demonstrating the presence of either dMMR status or MSI-H<br><br>Exclusion Criteria:<br><br> - Has distant metastatic disease.<br><br> - Has received prior medical therapy (chemotherapy, immunotherapy, biologic, or<br> targeted therapy), radiation therapy or surgery for management of colon cancer<br><br> - Has a tumor that, in the investigator's judgment is causing symptomatic bowel<br> obstruction or otherwise requires urgent/emergent surgery<br><br> - Has undergone any major surgical procedure, open biopsy, or experienced significant<br> traumatic injury within 28 days prior to randomization<br><br> - Has any history of interstitial lung disease or pneumonitis<br><br> - Has cirrhosis or current unstable liver or biliary disease per investigator<br> assessment defined by the presence of ascites, encephalopathy, coagulopathy,<br> hypoalbuminemia, esophageal/gastric varices, or persistent jaundice<br><br> - Has a history of allogenic stem cell transplantation or organ transplantation<br><br> - Is receiving any other anticancer or experimental therapy. No other experimental<br> therapies (including but not limited to chemotherapy, radiation, hormonal treatment,<br> antibody therapy, immunotherapy, gene therapy, vaccine therapy, or other<br> experimental drugs) of any kind are permitted while the participant is receiving<br> study intervention<br><br> - Is pregnant, breastfeeding, or expecting to conceive children within the projected<br> duration of the study<br><br> - Has a history of severe allergic and/or anaphylactic reactions to chimeric, human or<br> humanized antibodies, fusion proteins, or known allergies to dostarlimab, or its<br> excipients, or any components of FOLFOX or CAPEOX

Exclusion Criteria

Not provided

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Event-free Survival (EFS) Assessed by Blinded Independent Central Review (BICR)

Secondary Outcome Measures

Name	Time	Method
Overall Survival (OS);Number of Participants with Pathological Response;Event-free Survival (EFS) assessed by local assessment;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;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