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

NCT05855200
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Phase
Phase 3
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Recruitment status
Recruiting
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Participants
892
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Lead sponsor
GlaxoSmithKline
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Start date
2023-08-01
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Number of sites
266
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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.
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Short title
Study of Perioperative Dostarlimab in Participants With Untreated T4N0 or Stage III dMMR/MSI-H Resectable Colon Cancer
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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
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Control arm
Active comparator
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Registry reports results
No
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Listing at source
Listed
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Recruitment status
Recruiting
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Phase
Phase 3
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Study type
Interventional
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Completion date
2031-03-27
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First posted
2023-05-11
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Registry last updated
2026-01-23
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Primary completion date
2029-03-19
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Start date
2023-08-01
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Participants
892
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Participant count basis
Estimated
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Planned participants
892
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Protocol amendments
4
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Number of sites
266
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Data monitoring committee
Yes
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Registry sponsor category
Industry
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Lead sponsor
GlaxoSmithKline
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Source registry
ClinicalTrials.gov
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Registry ID
NCT05855200
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ClinicalTrials.gov ID
NCT05855200
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Registry record
Open registry record
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Allocation
Randomised
Model
Parallel groups
Purpose
Treatment
Masking
No masking
Masking description
Click here to enter text.
Sources for study design
clinicaltrials.gov

  1. Event-free Survival (EFS) Assessed by Blinded Independent Central Review (BICR)

    Timeframe: 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

  1. Overall Survival (OS)

    Timeframe: Up to approximately 5 years

    OS is defined as time from randomization to death from any cause

  2. Number of Participants with Pathological Response

    Timeframe: 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.

  3. Event-free Survival (EFS) assessed by local assessment

    Timeframe: 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-mediated Adverse Event (imAEs), AEs leading to death and AEs leading to discontinuation of study treatment

    Timeframe: Up to approximately 5 years

  5. Number of Participants with AEs and SAEs by Severity

    Timeframe: Up to approximately 5 years

  6. Serum Concentration of Dostarlimab

    Timeframe: 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)

    Timeframe: End of Infusion (EoI) of Cycle 1 to Cycle 10 (each cycle is of 21 days)

  8. Serum Predose trough concentration (Ctrough) of Dostarlimab

    Timeframe: Predose of Cycle 1 to Cycle 10 (each cycle is of 21 days)

  9. Number of Participants with Anti-Drug Antibodies against Dostarlimab

    Timeframe: Up to approximately 5 years

Sources for outcomes
clinicaltrials.gov

Sex
All
Age groups
Adults, Older adults
Minimum age
18 Years
Healthy volunteers
No

  • 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

  • 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
Sources for eligibility
clinicaltrials.gov

  • GSK Investigational SiteTucson, United StatesRecruiting
  • GSK Investigational SiteLos Angeles, United StatesRecruiting
  • GSK Investigational SiteNew Haven, United StatesRecruiting
  • GSK Investigational SiteWashington D.C., United StatesWithdrawn
  • GSK Investigational SiteDeerfield Beach, United StatesWithdrawn
  • GSK Investigational SiteFort Lauderdale, United StatesWithdrawn
  • GSK Investigational SiteMarietta, United StatesWithdrawn
  • GSK Investigational SiteChicago, United StatesRecruiting
  • GSK Investigational SiteChicago, United StatesRecruiting
  • GSK Investigational SiteChicago, United StatesWithdrawn
  • GSK Investigational SiteNaperville, United StatesRecruiting
  • GSK Investigational SiteNaperville, United StatesRecruiting
  • GSK Investigational SiteWestwood, United StatesRecruiting
  • GSK Investigational SiteLexington, United StatesWithdrawn
  • GSK Investigational SiteLouisville, United StatesWithdrawn
  • GSK Investigational SiteBaton Rouge, United StatesWithdrawn
  • GSK Investigational SiteBethesda, United StatesRecruiting
  • GSK Investigational SiteAnn Arbor, United StatesWithdrawn
  • GSK Investigational SiteDetroit, United StatesRecruiting
  • GSK Investigational SiteMinneapolis, United StatesRecruiting
  • GSK Investigational SiteJoplin, United StatesWithdrawn
  • GSK Investigational SiteSt Louis, United StatesWithdrawn
  • GSK Investigational SiteSt Louis, United StatesWithdrawn
  • GSK Investigational SiteGrand Island, United StatesRecruiting
  • GSK Investigational SiteOmaha, United StatesRecruiting

And 241 more, listed on the interactive page.

Sources for sites
clinicaltrials.gov

  • 2023
  • 2023-503265-27-00
Sources for references
clinicaltrials.gov

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