Groupe d'Etude en Oncologie du Quebec

Titre	A Phase 2, Single-Arm, Open-Label Study With Dostarlimab Monotherapy in Participants With Untreated Stage II/III dMMR/MSI-H Locally Advanced Rectal Cancer
Protocole ID	GSK-219369 (AZUR1)
ClinicalTrials.gov ID	NCT05723562
Type(s) de cancer	Côlon et rectum
Phase	Phase II
Stade	Localement avancé
Type étude	Clinique
Médicament	Dostarlimab
Institution	CENTRE HOSPITALIER DE L'UNIVERSITE DE MONTREAL
Ville	Montréal
Investigateur(trice) principal(e)	Dre Francine Aubin
Coordonnateur(trice)	Chantal Gosselin 514-890-8000 poste 24892
Statut	Actif en recrutement
Date d'activation	03-05-2023
Critètes d'éligibilité	Participant has histologically confirmed Stage II to III (T3-T4, N0, or T any, N+), locally advanced rectal cancer Participant has radiologically and endoscopically evaluable disease. Participant has a tumor which can be categorized as dMMR or MSI-H by local or central assessment
Critètes d'exclusion	Participant has distant metastatic disease. Participant has received prior radiation therapy, systemic therapy, or surgery for management of rectal cancer. Participant has any history of interstitial lung disease or pneumonitis Participant has experienced any of the following with prior immunotherapy: any irAE of Grade ≥3, immune-related severe neurologic events of any grade (e.g., myasthenic syndrome/myasthenia gravis, encephalitis, Guillain Barré Syndrome, or transverse myelitis), exfoliative dermatitis of any grade (Stevens-Johnson Syndrome, toxic epidermal necrolysis, or DRESS syndrome), or myocarditis of any grade. Non clinically significant laboratory abnormalities are not exclusionary. Participant has a known additional malignancy that progressed or required active treatment within the past 2 years. Exceptions include adequately treated superficial skin cancers, superficial bladder cancers, and other in situ cancers. Participant has an active autoimmune disease that has required systemic treatment in the past 2 years (i.e., with use of disease-modifying agents, corticosteroids, or immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment. Participant has a history of severe allergic and/or anaphylactic reactions to chimeric, human or humanized antibodies, fusion proteins, or has known allergies to dostarlimab or its excipients.

Groupe d'étude en oncologie du Québec