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RecruitingLast updated: 28 March 2024

AZUR-2: This study is evaluating whether receiving treatment with a monoclonal antibody, called Dostarlimab, before and after surgery is more effective than the current standard of care treatment in people with previously untreated cancer of the colonA 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

Clinical summary

Summary

This study is recruiting people with previously untreated T4N0 or Stage III, defective mismatch repair / microsatellite instability high colon cancer.

Eligible participants will be randomly allocated to one of two treatment arms.

In the Experimental Arm, participants will receive Dostarlimab pre and post surgery to remove their cancer.

In the Active Comparator Arm, participants will receive standard of care with one of two chemotherapy regimens (FOLFOX or CAPEOX), or undergo expectant observation post surgery.

Conditions

This trial is treating patients with untreated colon cancer that is able to be removed by surgery and is demonstrating the presence of either dMMR status or MSI-H

Cancer

Bowel Cancers Lower gastrointestinal tract

Age

People18+

Phase

III

Trial Acronym

AZUR-2

More information

Trial Identifiers

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Trial sponsor

GlaxoSmithKline

Scientific Title

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

Eligibility

Inclusion

  • 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

  • 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

Inclusion

  • You have been diagnosed with cancer, but have not received any treatment.
  • Your cancer has not spread to other parts of the body.

Exclusion

  • You have certain types of non-cancer medical conditions.
  • You have had certain treatments, surgical procedures or drugs.
Message

Clinical trials have complex eligibility criteria.

Ask your doctor if this trial could be right for you.

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