Study of Perioperative Dostarlimab in Participants With Untreated T4N0 or Stage III dMMR/MSI-H Resectable 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
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 18 Years and older
- Sex
- All sexes
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
Not stated in the study description — ask the study team about visits and procedures.
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This study tests dostarlimab given around the time of surgery compared with standard care. It is for people with untreated T4N0 or stage III colon cancer that can be removed by surgery and has certain gene repair changes called dMMR or MSI-H.
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.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- Have untreated colon adenocarcinoma, a type of colon cancer, confirmed by a tissue test.
- Have T4N0 or stage III colon cancer that can be removed by surgery.
- Have cancer that doctors can check using imaging scans.
- Have a tumor with dMMR or MSI-H, signs that cancer cells have trouble fixing errors in their genes.
Who can't join
- Have cancer that has spread to distant parts of the body.
- Have already had medicine, radiation, or surgery for this colon cancer, or are receiving other cancer treatment or experimental treatment.
- Have a tumor causing bowel blockage symptoms or needing urgent surgery. A past blockage relieved by a stoma (a surgical opening for stool) may be allowed. A blockage treated with a colon stent is not allowed.
- Had major surgery, an open surgical tissue sample, or a serious injury within 28 days before study group assignment.
- Have a history of lung tissue disease, lung inflammation, or bowel inflammation caused by radiation; or have liver scarring or unstable liver or bile duct disease.
- Have had a stem cell transplant from a donor or an organ transplant.
- Are pregnant, breastfeeding, or planning to conceive a child during the study.
- Have had severe allergic reactions to certain antibody or fusion protein medicines, or have known allergies to dostarlimab, its ingredients, or any part of the FOLFOX or CAPEOX chemotherapy treatments.
Simplified for readability. The official criteria below are what the study team uses.
Official 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
Study sites (49)
AZ
- GSK Investigational Site · Tucson, AZ 85715US GSK Clinical Trials Call Center · Study contact · 877-379-3718 · GSKClinicalSupportHD@gsk.comEU GSK Clinical Trials Call Centre · Study contact · +44 (0) 20 8990 4466 · GSKClinicalSupportHD@gsk.comManuel Modiano · Principal investigatorMore trials in Tucson
CA
- GSK Investigational Site · Los Angeles, CA 90027US GSK Clinical Trials Call Center · Study contact · 877-379-3718 · GSKClinicalSupportHD@gsk.comEU GSK Clinical Trials Call Centre · Study contact · +44 (0) 20 8990 4466 · GSKClinicalSupportHD@gsk.comGary Buchschacher Jr · Principal investigatorMore trials in Los Angeles
CT
- GSK Investigational Site · New Haven, CT 06520US GSK Clinical Trials Call Center · Study contact · 877-379-3718 · GSKClinicalSupportHD@gsk.comEU GSK Clinical Trials Call Centre · Study contact · +44 (0) 20 8990 4466 · GSKClinicalSupportHD@gsk.comJeremy Kortmansky · Principal investigatorMore trials in New Haven
DC
- GSK Investigational Site · Washington D.C., DC 20010More trials in Washington D.C.
FL
- GSK Investigational Site · Deerfield Beach, FL 33064More trials in Deerfield Beach
- GSK Investigational Site · Fort Lauderdale, FL 33316More trials in Fort Lauderdale
GA
- GSK Investigational Site · Marietta, GA 30060More trials in Marietta
IL
- GSK Investigational Site · Chicago, IL 60611US GSK Clinical Trials Call Center · Study contact · 877-379-3718 · GSKClinicalSupportHD@gsk.comEU GSK Clinical Trials Call Centre · Study contact · +44 (0) 20 8990 4466 · GSKClinicalSupportHD@gsk.comAl Benson Iii · Principal investigatorMore trials in Chicago
- GSK Investigational Site · Chicago, IL 60612US GSK Clinical Trials Call Center · Study contact · 877-379-3718 · GSKClinicalSupportHD@gsk.comEU GSK Clinical Trials Call Centre · Study contact · +44 (0) 20 8990 4466 · GSKClinicalSupportHD@gsk.comShikha Jain · Principal investigatorMore trials in Chicago
- GSK Investigational Site · Chicago, IL 60637More trials in Chicago
- GSK Investigational Site · Naperville, IL 60126US GSK Clinical Trials Call Center · Study contact · 877-379-3718 · GSKClinicalSupportHD@gsk.comEU GSK Clinical Trials Call Centre · Study contact · +44 (0) 20 8990 4466 · GSKClinicalSupportHD@gsk.comAndrew Wiele · Principal investigatorMore trials in Naperville
- GSK Investigational Site · Naperville, IL 60540US GSK Clinical Trials Call Center · Study contact · 877-379-3718 · GSKClinicalSupportHD@gsk.comEU GSK Clinical Trials Call Centre · Study contact · +44 (0) 20 8990 4466 · GSKClinicalSupportHD@gsk.comAndrew Wiele · Principal investigatorMore trials in Naperville
KS
- GSK Investigational Site · Westwood, KS 66205US GSK Clinical Trials Call Center · Study contact · 877-379-3718 · GSKClinicalSupportHD@gsk.comEU GSK Clinical Trials Call Centre · Study contact · +44 (0) 20 8990 4466 · GSKClinicalSupportHD@gsk.comBenjamin Martin · Principal investigatorMore trials in Westwood
KY
- GSK Investigational Site · Lexington, KY 40503More trials in Lexington
- GSK Investigational Site · Louisville, KY 40206More trials in Louisville
LA
- GSK Investigational Site · Baton Rouge, LA 70809More trials in Baton Rouge
MD
- GSK Investigational Site · Bethesda, MD 20817US GSK Clinical Trials Call Center · Study contact · 877-379-3718 · GSKClinicalSupportHD@gsk.comEU GSK Clinical Trials Call Centre · Study contact · +44 (0) 20 8990 4466 · GSKClinicalSupportHD@gsk.comMark Goldstein · Principal investigatorMore trials in Bethesda
MI
- GSK Investigational Site · Ann Arbor, MI 48109More trials in Ann Arbor
- GSK Investigational Site · Detroit, MI 48202US GSK Clinical Trials Call Center · Study contact · 877-379-3718 · GSKClinicalSupportHD@gsk.comEU GSK Clinical Trials Call Centre · Study contact · +44 (0) 20 8990 4466 · GSKClinicalSupportHD@gsk.comMaria Diab · Principal investigatorMore trials in Detroit
MN
- GSK Investigational Site · Minneapolis, MN 55455US GSK Clinical Trials Call Center · Study contact · 877-379-3718 · GSKClinicalSupportHD@gsk.comEU GSK Clinical Trials Call Centre · Study contact · +44 (0) 20 8990 4466 · GSKClinicalSupportHD@gsk.comAjay Prakash · Principal investigatorMore trials in Minneapolis
MO
- GSK Investigational Site · Joplin, MO 64804More trials in Joplin
- GSK Investigational Site · St Louis, MO 63128More trials in St Louis
- GSK Investigational Site · St Louis, MO 63141More trials in St Louis
NC
- GSK Investigational Site · Durham, NC 27710US GSK Clinical Trials Call Center · Study contact · 877-379-3718 · GSKClinicalSupportHD@gsk.comEU GSK Clinical Trials Call Centre · Study contact · +44 (0) 20 8990 4466 · GSKClinicalSupportHD@gsk.comJohn Strickler · Principal investigatorMore trials in Durham
NE
- GSK Investigational Site · Grand Island, NE 68803US GSK Clinical Trials Call Center · Study contact · 877-379-3718 · GSKClinicalSupportHD@gsk.comEU GSK Clinical Trials Call Centre · Study contact · +44 (0) 20 8990 4466 · GSKClinicalSupportHD@gsk.comTimothy Huyck · Principal investigatorMore trials in Grand Island
- GSK Investigational Site · Omaha, NE 68130US GSK Clinical Trials Call Center · Study contact · 877-379-3718 · GSKClinicalSupportHD@gsk.comEU GSK Clinical Trials Call Centre · Study contact · +44 (0) 20 8990 4466 · GSKClinicalSupportHD@gsk.comTimothy Huyck · Principal investigatorMore trials in Omaha
- GSK Investigational Site · Omaha, NE 68198More trials in Omaha
NH
- GSK Investigational Site · Lebanon, NH 03756More trials in Lebanon
NY
- GSK Investigational Site · New York, NY 10028US GSK Clinical Trials Call Center · Study contact · 877-379-3718 · GSKClinicalSupportHD@gsk.comEU GSK Clinical Trials Call Centre · Study contact · +44 (0) 20 8990 4466 · GSKClinicalSupportHD@gsk.comRichard Zuniga · Principal investigatorMore trials in New York
- GSK Investigational Site · New York, NY 10469US GSK Clinical Trials Call Center · Study contact · 877-379-3718 · GSKClinicalSupportHD@gsk.comEU GSK Clinical Trials Call Centre · Study contact · +44 (0) 20 8990 4466 · GSKClinicalSupportHD@gsk.comRichard Zuniga · Principal investigatorMore trials in New York
- GSK Investigational Site · New York, NY 11042US GSK Clinical Trials Call Center · Study contact · 877-379-3718 · GSKClinicalSupportHD@gsk.comEU GSK Clinical Trials Call Centre · Study contact · +44 (0) 20 8990 4466 · GSKClinicalSupportHD@gsk.comRichard Zuniga · Principal investigatorMore trials in New York
- GSK Investigational Site · New York, NY 11967US GSK Clinical Trials Call Center · Study contact · 877-379-3718 · GSKClinicalSupportHD@gsk.comEU GSK Clinical Trials Call Centre · Study contact · +44 (0) 20 8990 4466 · GSKClinicalSupportHD@gsk.comRichard Zuniga · Principal investigatorMore trials in New York
- GSK Investigational Site · The Bronx, NY 10461US GSK Clinical Trials Call Center · Study contact · 877-379-3718 · GSKClinicalSupportHD@gsk.comEU GSK Clinical Trials Call Centre · Study contact · +44 (0) 20 8990 4466 · GSKClinicalSupportHD@gsk.comFernand Bteich · Principal investigatorMore trials in The Bronx
OH
- GSK Investigational Site · Akron, OH 44304US GSK Clinical Trials Call Center · Study contact · 877-379-3718 · GSKClinicalSupportHD@gsk.comEU GSK Clinical Trials Call Centre · Study contact · +44 (0) 20 8990 4466 · GSKClinicalSupportHD@gsk.comSameer Mahesh · Principal investigatorMore trials in Akron
- GSK Investigational Site · Cincinnati, OH 45220US GSK Clinical Trials Call Center · Study contact · 877-379-3718 · GSKClinicalSupportHD@gsk.comEU GSK Clinical Trials Call Centre · Study contact · +44 (0) 20 8990 4466 · GSKClinicalSupportHD@gsk.comBenjamin Kuritzky · Principal investigatorMore trials in Cincinnati
- GSK Investigational Site · Cleveland, OH 44111More trials in Cleveland
- GSK Investigational Site · Cleveland, OH 44142More trials in Cleveland
- GSK Investigational Site · Cleveland, OH 44196More trials in Cleveland
OK
- GSK Investigational Site · Oklahoma City, OK 73104More trials in Oklahoma City
- GSK Investigational Site · Oklahoma City, OK 73120More trials in Oklahoma City
PA
- GSK Investigational Site · Pittsburgh, PA 15212More trials in Pittsburgh
SD
- GSK Investigational Site · Sioux Falls, SD 57078US GSK Clinical Trials Call Center · Study contact · 877-379-3718 · GSKClinicalSupportHD@gsk.comEU GSK Clinical Trials Call Centre · Study contact · +44 (0) 20 8990 4466 · GSKClinicalSupportHD@gsk.comHeidi McKean · Principal investigatorMore trials in Sioux Falls
- GSK Investigational Site · Sioux Falls, SD 57105US GSK Clinical Trials Call Center · Study contact · 877-379-3718 · GSKClinicalSupportHD@gsk.comEU GSK Clinical Trials Call Centre · Study contact · +44 (0) 20 8990 4466 · GSKClinicalSupportHD@gsk.comHeidi McKean · Principal investigatorMore trials in Sioux Falls
- GSK Investigational Site · Sioux Falls, SD 57401US GSK Clinical Trials Call Center · Study contact · 877-379-3718 · GSKClinicalSupportHD@gsk.comEU GSK Clinical Trials Call Centre · Study contact · +44 (0) 20 8990 4466 · GSKClinicalSupportHD@gsk.comHeidi McKean · Principal investigatorMore trials in Sioux Falls
- GSK Investigational Site · Sioux Falls, SD 57501US GSK Clinical Trials Call Center · Study contact · 877-379-3718 · GSKClinicalSupportHD@gsk.comEU GSK Clinical Trials Call Centre · Study contact · +44 (0) 20 8990 4466 · GSKClinicalSupportHD@gsk.comHeidi McKean · Principal investigatorMore trials in Sioux Falls
TX
- GSK Investigational Site · Dallas, TX 75235More trials in Dallas
- GSK Investigational Site · Dallas, TX 75390More trials in Dallas
VA
- GSK Investigational Site · Richmond, VA 23229US GSK Clinical Trials Call Center · Study contact · 877-379-3718 · GSKClinicalSupportHD@gsk.comEU GSK Clinical Trials Call Centre · Study contact · +44 (0) 20 8990 4466 · GSKClinicalSupportHD@gsk.comPurvi Shah · Principal investigatorMore trials in Richmond
WI
- GSK Investigational Site · Appleton, WI 54911US GSK Clinical Trials Call Center · Study contact · 877-379-3718 · GSKClinicalSupportHD@gsk.comEU GSK Clinical Trials Call Centre · Study contact · +44 (0) 20 8990 4466 · GSKClinicalSupportHD@gsk.comJoyce Philip · Principal investigatorMore trials in Appleton