Health Trials

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

ConditionsColonic NeoplasmsNeoplasms, Colon
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorGlaxoSmithKline

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Dostarlimab

    Biological/Vaccine

    Dostarlimab will be administered.

  • CAPEOX

    Drug

    CAPEOX will be administered.

  • FOLFOX

    Drug

    FOLFOX will be administered.

Treatment groups

892 Participants
are divided into 2 treatment groups
Group A: DostarlimabExperimental treatment 1 intervention
Group B: Standard of Care (SOC)Active comparator 2 interventions

Trial outcomes

Primary outcomes

1

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

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

Time frame
Up to approximately 5 years

Secondary outcomes

1

Overall Survival (OS)

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

Time frame
Up to approximately 5 years
2

Number of Participants with Pathological Response

Pathological response will be categorized as a complete pathologic response, major pathologic response, partial pathologic response, or negligible pathologic response.

Time frame
Up to approximately 5 years
3

Event-free Survival (EFS) assessed by local assessment

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

Time frame
Up to approximately 5 years
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

Time frame
Up to approximately 5 years

Other outcomes

Locations

1

Map coordinates are unavailable for these locations. Locations are shown below instead.

GSK Investigational SiteRecruiting Punta Pacifica Panama City PanamaPanamaPanama

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

GlaxoSmithKline

Lead sponsor

Source ClinicalTrials.gov
Apply now