Study of Perioperative Dostarlimab in Participants With Untreated T4N0 or Stage III dMMR/MSI-H Resectable Colon Cancer (AZUR-2)
Colonic Neoplasms, Neoplasms, Colon
About this trial
This is an interventional treatment trial for Colonic Neoplasms focused on measuring JEMPERLI, Dostarlimab, dostarlimab-gxly, TSR-042, GSK4057190A, FOLFOX, CAPEOX, Colon Cancer, Resectable colon cancer, dMMR/MSI, Perioperative, Neoadjuvant, Adjuvant
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 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 enrollment 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
Sites / Locations
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Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
Dostarlimab
Standard of Care (SOC)
Participants will receive Dostarlimab pre and post surgery
Participants will receive SOC (FOLFOX/CAPEOX) or undergo expectant observation post surgery.