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Trial record 1 of 1 for:    219606
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Study of Perioperative Dostarlimab in Participants With Untreated T4N0 or Stage III dMMR/MSI-H Resectable Colon Cancer (AZUR-2)

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ClinicalTrials.gov Identifier: NCT05855200
Recruitment Status : Recruiting
First Posted : May 11, 2023
Last Update Posted : February 20, 2024
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Colonic Neoplasms Neoplasms, Colon Biological: Dostarlimab Drug: CAPEOX Drug: FOLFOX Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 711 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Masking Description: Click here to enter text.
Primary Purpose: Treatment
Official 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
Actual Study Start Date : August 2, 2023
Estimated Primary Completion Date : December 15, 2028
Estimated Study Completion Date : December 25, 2030

Resource links provided by the National Library of Medicine

Drug Information available for: Dostarlimab

Arms and Interventions
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Arm Intervention/treatment
Experimental: Dostarlimab
Participants will receive Dostarlimab pre and post surgery
 Biological: Dostarlimab
Dostarlimab will be administered.
Active Comparator: Standard of Care (SOC)
Participants will receive SOC (FOLFOX/CAPEOX) or undergo expectant observation post surgery.
 Drug: CAPEOX
CAPEOX will be administered.

Drug: FOLFOX
FOLFOX will be administered.


Outcome Measures
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Primary Outcome Measures :
  1. Event-free Survival (EFS) Assessed by Blinded Independent Central Review (BICR) [ Time Frame: Up to approximately 5 years ]
    EFS is defined as the time from randomization to either disease recurrence or death due to any cause or treatment related toxicity that results in the participant not being suitable for surgery


Secondary Outcome Measures :
  1. Number of Participants with Pathological Response [ Time Frame: Up to approximately 5 years ]
    Pathological response will be categorized as a complete pathologic response, major pathologic response, partial pathologic response, or negligible pathologic response.

  2. Overall Survival (OS) [ Time Frame: Up to approximately 5 years ]
    OS is defined as time from randomization to death from any cause

  3. Event-free Survival (EFS) assessed by local assessment [ Time Frame: Up to approximately 5 years ]
    EFS is defined as the time from randomization to either disease recurrence or death due to any cause or treatment related toxicity that results in the participant not being suitable for surgery

  4. Number of Participants with treatment emergent adverse events (AEs), serious adverse events (SAEs), Immune-related Adverse Event (irAEs), AEs leading to death and AEs leading to discontinuation of study treatment [ Time Frame: Up to approximately 5 years ]
  5. Number of Participants with AEs and SAEs by Severity [ Time Frame: Up to approximately 5 years ]
  6. Serum Concentration of Dostarlimab [ Time Frame: Predose and End of Infusion (EoI) of Cycle 1 and EoI of Cycle 2 to Cycle 10 (each cycle is of 21 days) ]
  7. Serum Concentration of Dostarlimab at End of Infusion (C-EoI) [ Time Frame: End of Infusion (EoI) of Cycle 1 to Cycle 10 (each cycle is of 21 days) ]
  8. Serum Predose trough concentration (Ctrough) of Dostarlimab [ Time Frame: Predose of Cycle 1 to Cycle 10 (each cycle is of 21 days) ]
  9. Number of Participants with Anti-Drug Antibodies against Dostarlimab [ Time Frame: Up to approximately 5 years ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05855200


Contacts
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Contact: US GSK Clinical Trials Call Center 877-379-3718 GSKClinicalSupportHD@gsk.com
Contact: EU GSK Clinical Trials Call Center +44 (0) 20 89904466 GSKClinicalSupportHD@gsk.com

Locations
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Sponsors and Collaborators
GlaxoSmithKline
Investigators
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Study Director: GSK Clinical Trials GlaxoSmithKline
More Information
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Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT05855200    
Other Study ID Numbers: 219606
2023-503265-27-00 ( Other Identifier: European Medicines Agency )
First Posted: May 11, 2023    Key Record Dates
Last Update Posted: February 20, 2024
Last Verified: February 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Qualified researchers may request access to anonymized individual patient-level data (IPD) and related study documents of the eligible studies via the Data Sharing Portal. Details on GSK's data sharing criteria can be found at: https://www.gsk.com/en-gb/innovation/trials/data-transparency/
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Time Frame: Anonymized IPD will be made available within 6 months of publication of primary, key secondary and safety results for studies in product with approved indication(s) or terminated asset(s) across all indications.
Access Criteria: Anonymized IPD is shared with researchers whose proposals are approved by an Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension may be granted, when justified, for up to 6 months.
URL: https://www.gsk.com/en-gb/innovation/trials/data-transparency/

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by GlaxoSmithKline:
JEMPERLI
Dostarlimab
dostarlimab-gxly
TSR-042
GSK4057190A
FOLFOX
CAPEOX
 Colon Cancer
Resectable colon cancer
dMMR/MSI
Perioperative
Neoadjuvant
Adjuvant
Additional relevant MeSH terms:
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Neoplasms
Colonic Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
 Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Dostarlimab
Antineoplastic Agents