Colonic Neoplasms, Neoplasms, Colon
Conditions
Keywords
JEMPERLI, Dostarlimab, dostarlimab-gxly, TSR-042, GSK4057190A, FOLFOX, CAPEOX, Colon Cancer, Resectable colon cancer, dMMR/MSI, Perioperative, Neoadjuvant, Adjuvant
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.
Interventions
BIOLOGICALDostarlimab
Dostarlimab will be administered.
DRUGCAPEOX
CAPEOX will be administered.
DRUGFOLFOX
FOLFOX will be administered.
Sponsors
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Masking description
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Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Event-free Survival (EFS) Assessed by Blinded Independent Central Review (BICR) | 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
| Measure | Time frame | Description |
|---|---|---|
| Overall Survival (OS) | Up to approximately 5 years | OS is defined as time from randomization to death from any cause |
| Number of Participants with Pathological Response | 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. |
| Event-free Survival (EFS) assessed by local assessment | 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 |
| 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 | Up to approximately 5 years | — |
| Number of Participants with AEs and SAEs by Severity | Up to approximately 5 years | — |
| Serum Concentration of Dostarlimab | Predose and End of Infusion (EoI) of Cycle 1 and EoI of Cycle 2 to Cycle 10 (each cycle is of 21 days) | — |
| Serum Concentration of Dostarlimab at End of Infusion (C-EoI) | End of Infusion (EoI) of Cycle 1 to Cycle 10 (each cycle is of 21 days) | — |
| Serum Predose trough concentration (Ctrough) of Dostarlimab | Predose of Cycle 1 to Cycle 10 (each cycle is of 21 days) | — |
| Number of Participants with Anti-Drug Antibodies against Dostarlimab | Up to approximately 5 years | — |
Countries
Argentina, Australia, Belgium, Brazil, Canada, China, Czechia, Estonia, Finland, France, Germany, Greece, India, Italy, Japan, Mexico, Netherlands, Norway, Panama, Poland, Portugal, South Korea, Spain, Sweden, Taiwan, Turkey (Türkiye), United Kingdom, United States
Contacts
CONTACTUS GSK Clinical Trials Call Center
CONTACTEU GSK Clinical Trials Call Center
STUDY_DIRECTORGSK Clinical Trials
GlaxoSmithKline
Outcome results
None listed