Study of Perioperative Dostarlimab in Participants With Untreated T4N0 or Stage III dMMR/MSI-H Resectable Colon Cancer (AZUR-2)

GlaxoSmithKline (GSK)

Status and phase: Enrolling; Phase 3

Conditions: Colonic Neoplasms; Neoplasms, Colon

Treatments: Drug: FOLFOX; Biological: Dostarlimab; Drug: CAPEOX

Study type: Interventional

Funder types: Industry

Identifiers

NCT05855200

2023-503265-27-00 (Other Identifier)

219606

Details and patient eligibility

About

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.

Enrollment: 711 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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711 participants in 2 patient groups

Dostarlimab

Experimental group

Description:

Participants will receive Dostarlimab pre and post surgery

Treatment:

Biological: Dostarlimab

Standard of Care (SOC)

Active Comparator group

Description:

Participants will receive SOC (FOLFOX/CAPEOX) or undergo expectant observation post surgery.

Treatment:

Drug: CAPEOX

Drug: FOLFOX