RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood 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.

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

Quick Facts

Study Start:2023-08-01
Study Completion:2030-12-25
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05855200

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.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Has untreated pathologically confirmed colon adenocarcinoma
  2. * Has resectable colon adenocarcinoma defined as clinically T4N0 or Stage III
  3. * Has radiologically evaluable disease
  4. * Has a tumor demonstrating the presence of either dMMR status or MSI-H
  1. * Has distant metastatic disease.
  2. * Has received prior medical therapy (chemotherapy, immunotherapy, biologic, or targeted therapy), radiation therapy or surgery for management of colon cancer
  3. * Has a tumor that, in the investigator's judgment is causing symptomatic bowel obstruction or otherwise requires urgent/emergent surgery
  4. * Has undergone any major surgical procedure, open biopsy, or experienced significant traumatic injury within 28 days prior to randomization
  5. * Has any history of interstitial lung disease or pneumonitis
  6. * 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
  7. * Has a history of allogenic stem cell transplantation or organ transplantation
  8. * 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
  9. * Is pregnant, breastfeeding, or expecting to conceive children within the projected duration of the study
  10. * 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

Contacts and Locations

Study Contact

US GSK Clinical Trials Call Center
CONTACT
877-379-3718
GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Center
CONTACT
+44 (0) 20 89904466
GSKClinicalSupportHD@gsk.com

Principal Investigator

GSK Clinical Trials
STUDY_DIRECTOR
GlaxoSmithKline

Study Locations (Sites)

GSK Investigational Site
Tucson, Arizona, 85715
United States
GSK Investigational Site
Los Angeles, California, 90027
United States
GSK Investigational Site
New Haven, Connecticut, 06520
United States
GSK Investigational Site
Washington, District of Columbia, 20010
United States
GSK Investigational Site
Deerfield Beach, Florida, 33064
United States
GSK Investigational Site
Fort Lauderdale, Florida, 33316
United States
GSK Investigational Site
Marietta, Georgia, 30060
United States
GSK Investigational Site
Chicago, Illinois, 60611
United States
GSK Investigational Site
Chicago, Illinois, 60612
United States
GSK Investigational Site
Chicago, Illinois, 60637
United States
GSK Investigational Site
Naperville, Illinois, 60126
United States
GSK Investigational Site
Naperville, Illinois, 60540
United States
GSK Investigational Site
Westwood, Kansas, 66205
United States
GSK Investigational Site
Lexington, Kentucky, 40503
United States
GSK Investigational Site
Louisville, Kentucky, 40206
United States
GSK Investigational Site
Baton Rouge, Louisiana, 70809
United States
GSK Investigational Site
Bethesda, Maryland, 20817
United States
GSK Investigational Site
Ann Arbor, Michigan, 48109
United States
GSK Investigational Site
Detroit, Michigan, 48202
United States
GSK Investigational Site
Minneapolis, Minnesota, 55455
United States
GSK Investigational Site
Joplin, Missouri, 64804
United States
GSK Investigational Site
Saint Louis, Missouri, 63128
United States
GSK Investigational Site
Saint Louis, Missouri, 63141
United States
GSK Investigational Site
Omaha, Nebraska, 68130
United States
GSK Investigational Site
Omaha, Nebraska, 68198
United States
GSK Investigational Site
Omaha, Nebraska, 68803
United States
GSK Investigational Site
Lebanon, New Hampshire, 03756
United States
GSK Investigational Site
Bronx, New York, 10461
United States
GSK Investigational Site
New York, New York, 10028
United States
GSK Investigational Site
New York, New York, 10065
United States
GSK Investigational Site
New York, New York, 10469
United States
GSK Investigational Site
New York, New York, 11042
United States
GSK Investigational Site
New York, New York, 11967
United States
GSK Investigational Site
Durham, North Carolina, 27710
United States
GSK Investigational Site
Greenville, North Carolina, 27834
United States
GSK Investigational Site
Akron, Ohio, 44304
United States
GSK Investigational Site
Cincinnati, Ohio, 45220
United States
GSK Investigational Site
Cleveland, Ohio, 44111
United States
GSK Investigational Site
Cleveland, Ohio, 44142
United States
GSK Investigational Site
Cleveland, Ohio, 44196
United States
GSK Investigational Site
Oklahoma City, Oklahoma, 73104
United States
GSK Investigational Site
Oklahoma City, Oklahoma, 73120
United States
GSK Investigational Site
Pittsburgh, Pennsylvania, 15212
United States
GSK Investigational Site
Wynnewood, Pennsylvania, 19096
United States
GSK Investigational Site
Sioux Falls, South Dakota, 57078
United States
GSK Investigational Site
Sioux Falls, South Dakota, 57105
United States
GSK Investigational Site
Sioux Falls, South Dakota, 57401
United States
GSK Investigational Site
Sioux Falls, South Dakota, 57501
United States
GSK Investigational Site
Nashville, Tennessee, 37232
United States
GSK Investigational Site
Dallas, Texas, 75235
United States
GSK Investigational Site
Dallas, Texas, 75390-8565
United States
GSK Investigational Site
Richmond, Virginia, 23229
United States
GSK Investigational Site
Appleton, Wisconsin, 54911
United States

Collaborators and Investigators

Sponsor: GlaxoSmithKline

  • GSK Clinical Trials, STUDY_DIRECTOR, GlaxoSmithKline

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-08-01
Study Completion Date2030-12-25

Study Record Updates

Study Start Date2023-08-01
Study Completion Date2030-12-25

Terms related to this study

Keywords Provided by Researchers

  • JEMPERLI
  • Dostarlimab
  • dostarlimab-gxly
  • TSR-042
  • GSK4057190A
  • FOLFOX
  • CAPEOX
  • Colon Cancer
  • Resectable colon cancer
  • dMMR/MSI
  • Perioperative
  • Neoadjuvant
  • Adjuvant

Additional Relevant MeSH Terms

  • Colonic Neoplasms
  • Neoplasms, Colon