A Phase 2 Study With Dostarlimab Monotherapy in Participants With Untreated Stage II/III dMMR/MSI-H Locally Advanced Rectal Cancer (AZUR-1)

JRCT ID: jRCT2031220656

Registered date:23/02/2023

Basic Information

• Recruitment status: Pending
• Health condition(s) or Problem(s) studied: Rectal cancer
• Date of first enrollment: 31/03/2023
• Target sample size: 100
• Countries of recruitment: United Kingdom,Japan
• Study type: Interventional

Intervention(s)

Dostarlimab
Dostarlimab will be administered.

Outcome(s)

• Primary Outcome: The efficacy of dostarlimab in participants with Stage II/III (locally advanced) dMMR/MSI-H rectal cancer.
• Secondary Outcome: The efficacy, safety, immunogenicity and PK of dostarlimab in participants with Stage II/III (locally advanced) dMMR/MSI-H rectal cancer.

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

-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

Exclude criteria

-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 Barre 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

Related Information

• Primary Sponsor: Ishibashi Hideyasu