RecruitingPhase 3

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

CA

CT

DC

FL

GA

IL

KS

KY

LA

MD

MI

MN

MO

NC

NE

NH

NY

OH

OK

PA

SD

TX

VA

WI