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.
Brief Title
Study of Perioperative Dostarlimab in Participants With Untreated T4N0 or Stage III dMMR/MSI-H Resectable Colon Cancer
Categories
Central Contacts
Central Contact Role
Contact
Central Contact Phone
877-379-3718
Central Contact Email
GSKClinicalSupportHD@gsk.com
Central Contact Role
Contact
Central Contact Phone
+44 (0) 20 89904466
Central Contact Email
GSKClinicalSupportHD@gsk.com
Completion Date
Completion Date Type
Estimated
Conditions
Colonic Neoplasms
Neoplasms, Colon
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 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
* 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 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
Inclusion 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
* 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
Gender
All
Gender Based
false
Keywords
JEMPERLI
Dostarlimab
dostarlimab-gxly
TSR-042
GSK4057190A
FOLFOX
CAPEOX
Colon Cancer
Resectable colon cancer
dMMR/MSI
Perioperative
Neoadjuvant
Adjuvant
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Estimated
Last Update Submit Date
Minimum Age
18 Years
NCT Id
NCT05855200
Org Class
Industry
Org Full Name
GlaxoSmithKline
Org Study Id
219606
Overall Status
Recruiting
Phases
Phase 3
Primary Completion Date
Primary Completion Date Type
Estimated
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
Primary Outcomes
Outcome Description
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
Outcome Measure
Event-free Survival (EFS) Assessed by Blinded Independent Central Review (BICR)
Outcome Time Frame
Up to approximately 5 years
Secondary Ids
Secondary Id
2023-503265-27-00
Secondary Outcomes
Outcome Description
OS is defined as time from randomization to death from any cause
Outcome Time Frame
Up to approximately 5 years
Outcome Measure
Overall Survival (OS)
Outcome Description
Pathological response will be categorized as a complete pathologic response, major pathologic response, partial pathologic response, or negligible pathologic response.
Outcome Time Frame
Up to approximately 5 years
Outcome Measure
Number of Participants with Pathological Response
Outcome Description
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
Outcome Time Frame
Up to approximately 5 years
Outcome Measure
Event-free Survival (EFS) assessed by local assessment
Outcome Time Frame
Up to approximately 5 years
Outcome Measure
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
Outcome Time Frame
Up to approximately 5 years
Outcome Measure
Number of Participants with AEs and SAEs by Severity
Outcome 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)
Outcome Measure
Serum Concentration of Dostarlimab
Outcome Time Frame
End of Infusion (EoI) of Cycle 1 to Cycle 10 (each cycle is of 21 days)
Outcome Measure
Serum Concentration of Dostarlimab at End of Infusion (C-EoI)
Outcome Time Frame
Predose of Cycle 1 to Cycle 10 (each cycle is of 21 days)
Outcome Measure
Serum Predose trough concentration (Ctrough) of Dostarlimab
Outcome Time Frame
Up to approximately 5 years
Outcome Measure
Number of Participants with Anti-Drug Antibodies against Dostarlimab
Start Date
Start Date Type
Actual
Status Verified Date
First Post Date
First Post Date Type
Actual
First Submit Date
First Submit QC Date
Std Ages
Adult
Older Adult
Maximum Age Number (converted to Years and rounded down)
999
Minimum Age Number (converted to Years and rounded down)
18
Investigators
Investigator Type
Principal Investigator
Investigator Name
Fernand Bteich
Investigator Email
fbteich@montefiore.org