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

ReclutandoFase 3ClinicalTrials.gov

ID: NCT05855200Tipo: INTERVENTIONALInicio: 1 de ago de 2023Fin estimado: 27 de mar de 2031

Traducción no disponible, mostrando original

Resumen

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.

Elegibilidad

Edad mínima: 18 YearsSexo: ALL

Criterios de inclusión

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

Criterios de exclusión

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

Intervenciones

biological

Dostarlimab

Dostarlimab will be administered.

drug

CAPEOX

CAPEOX will be administered.

drug

FOLFOX

FOLFOX will be administered.

Ubicaciones

GSK Investigational Site

Buenos Aires, Argentina

US GSK Clinical Trials Call Center · GSKClinicalSupportHD@gsk.com · 877-379-3718

RECRUITING

GSK Investigational Site

Buenos Aires, Argentina

US GSK Clinical Trials Call Center · GSKClinicalSupportHD@gsk.com · 877-379-3718

RECRUITING

GSK Investigational Site

Buenos Aires, Argentina

US GSK Clinical Trials Call Center · GSKClinicalSupportHD@gsk.com · 877-379-3718

RECRUITING

GSK Investigational Site

Capital Federal, Argentina

US GSK Clinical Trials Call Center · GSKClinicalSupportHD@gsk.com · 877-379-3718

RECRUITING

GSK Investigational Site

Ciudad Autonoma de Buenos Aire, Argentina

COMPLETED

GSK Investigational Site

Córdoba, Argentina

US GSK Clinical Trials Call Center · GSKClinicalSupportHD@gsk.com · 877-379-3718

RECRUITING

GSK Investigational Site

Mar del Plata, Argentina

US GSK Clinical Trials Call Center · GSKClinicalSupportHD@gsk.com · 877-379-3718

RECRUITING

GSK Investigational Site

Rosario, Argentina

US GSK Clinical Trials Call Center · GSKClinicalSupportHD@gsk.com · 877-379-3718

RECRUITING

GSK Investigational Site

San Miguel de Tucumán, Argentina

US GSK Clinical Trials Call Center · GSKClinicalSupportHD@gsk.com · 877-379-3718

RECRUITING

GSK Investigational Site

Santa Fe, Argentina

US GSK Clinical Trials Call Center · GSKClinicalSupportHD@gsk.com · 877-379-3718

RECRUITING

Patrocinadores

PrincipalGlaxoSmithKline

Contactos

US GSK Clinical Trials Call Center

CONTACT

GSKClinicalSupportHD@gsk.com 877-379-3718

EU GSK Clinical Trials Call Center

CONTACT

GSKClinicalSupportHD@gsk.com +44 (0) 20 89904466

Aviso: La información de este ensayo proviene de fuentes públicas y tiene carácter exclusivamente informativo. No constituye asesoramiento médico, regulatorio ni de ningún otro tipo. Las traducciones son automatizadas y no poseen validez oficial. Consultá siempre con un profesional de la salud. Ver Términos de Uso.

A Phase 3, Open-Label, Randomized Study of Perioperative ... | EligiMed