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

Description

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.

Conditions

Colonic Neoplasms, Neoplasms, Colon

Study Overview

Study Details

Study 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.

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

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

Condition
Colonic Neoplasms
Intervention / Treatment

-

Contacts and Locations

Tucson

GSK Investigational Site, Tucson, Arizona, United States, 85715

Los Angeles

GSK Investigational Site, Los Angeles, California, United States, 90027

New Haven

GSK Investigational Site, New Haven, Connecticut, United States, 06520

Washington

GSK Investigational Site, Washington, District of Columbia, United States, 20010

Deerfield Beach

GSK Investigational Site, Deerfield Beach, Florida, United States, 33064

Fort Lauderdale

GSK Investigational Site, Fort Lauderdale, Florida, United States, 33316

Marietta

GSK Investigational Site, Marietta, Georgia, United States, 30060

Chicago

GSK Investigational Site, Chicago, Illinois, United States, 60611

Chicago

GSK Investigational Site, Chicago, Illinois, United States, 60612

Chicago

GSK Investigational Site, Chicago, Illinois, United States, 60637

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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 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 randomization
  • * 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

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

GlaxoSmithKline,

GSK Clinical Trials, STUDY_DIRECTOR, GlaxoSmithKline

Study Record Dates

2030-12-25