RecruitingPhase 3NCT05855200
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
Sponsor
GlaxoSmithKline
Enrollment
892 participants
Start Date
Aug 1, 2023
Study Type
INTERVENTIONAL
Conditions
Summary
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.
Eligibility
Min Age: 18 Years
Inclusion Criteria4
- 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 Criteria10
- 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
Interventions
BIOLOGICALDostarlimab
Dostarlimab will be administered.
DRUGCAPEOX
CAPEOX will be administered.
DRUGFOLFOX
FOLFOX will be administered.
Locations(266)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT05855200
Related Trials
A Study of Neoadjuvant Dostarlimab Plus Capecitabine Plus Oxaliplatin (CAPEOX) Vs CAPEOX With Previously Untreated T4N0 or Stage III Mismatch Repair Proficient (MMRp)/Microsatellite Stable (MSS) Colon Cancer
NCT0656778231 locations
Anti-Mesothelin TNaive/SCM hYP218 (TNhYP218) CAR T Cells in Participants With Mesothelin-Expressing Solid Tumors Including Mesothelioma
NCT068856971 location
Strategies for Optimizing a Mailed FIT Program in Appalachia
NCT071739851 location
Adaptive Randomization of Aerobic Exercise During Chemotherapy in Colon Cancer
NCT057731443 locations
Endoscopic Resection of Gastrointestinal Neoplasms
NCT047802561 location